Sophic Logo gordian knotPediatric Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in December 2025


Powered by Sophic Starlight


Disclaimer and Important Notice:

Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is provided for educational and consulting purposes only. This report is not a substitute for professional medical advice, diagnosis, or treatment. Sophic shall not be held responsible for any interpretation, application, or use of this report beyond these purposes.

The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. Reports are provided entirely free of charge, and patients should never be billed or charged for access to this information. Users agree to reference Sophic in any publication, presentation, or publicity that incorporates or relies upon information from Sophic Starlight Cancer Clinical Trials Intelligence Reports.


1: Summary data from new trials identified for Pediatric Cancer.


Overview

Number of Trials: 25

These 25 trials span diverse oncology and supportive care interventions. Pediatric and young adult cancers dominate, including brain tumors (gliomas, medulloblastoma, DIPG), sarcomas (Ewing, osteosarcoma, rhabdomyosarcoma), leukemias (ALL, T-cell malignancies), and solid tumors (neuroblastoma, hepatocellular carcinoma). Adult trials address breast, ovarian, endometrial, cervical, multiple myeloma, and metastatic cancers. Interventions include novel CAR-T therapies, oncolytic viruses, targeted small molecules (RBM39 degraders, MET inhibitors, kinase inhibitors), radiation (hypofractionated, short-course), imaging agents (18F-Fluciclovine, MeFAMP-PET), digital health tools, genetic testing platforms, and supportive care (aspirin for endometrial inflammation, negative pressure wound therapy, virtual reality for fear of progression). Several trials test experimental agents lacking FDA approval (AMXT 1501, ST-01156, M032 oncolytic HSV, VP-102 for warts, broccoli microgreens). Trials emphasize precision medicine (genomic profiling, MRD monitoring), immunotherapy combinations, and quality-of-life interventions.

Common Criteria Across Trials

Common Inclusion

  • Age-specific criteria (pediatric: ≥1-2 years to ≤21 years; AYA: 18-39 years; adults: ≥18 years)
  • Histologically confirmed malignancy or radiographic diagnosis (DIPG)
  • Measurable or evaluable disease
  • Performance status: Karnofsky/Lansky ≥50-70
  • Adequate organ function (renal: GFR/CrCl ≥50-70 mL/min/1.73m²; hepatic: bilirubin ≤1.5-3× ULN, AST/ALT ≤3-5× ULN; cardiac: LVEF ≥50% or SF ≥27%; hematologic: ANC ≥750-1000/µL, platelets ≥50,000-100,000/µL, Hgb ≥7-9 g/dL)
  • Recovery from prior therapy toxicities
  • Informed consent/assent
  • Negative pregnancy test for females of childbearing potential
  • Contraception agreement during study and post-treatment (typically 3-6 months)

Common Exclusion

  • Active uncontrolled infection (bacterial, fungal, viral; exceptions for HBV/HCV in some trials)
  • HIV positivity (unless controlled with specific criteria)
  • Pregnancy or breastfeeding
  • Concurrent investigational agents or anticancer therapy
  • Uncontrolled cardiac disease (NYHA III/IV, recent MI, arrhythmias)
  • CNS disease (active metastases, uncontrolled seizures, or CNS-3 leukemia in some trials)
  • Prior organ transplantation (in immunotherapy trials)
  • Systemic corticosteroids >0.5 mg/kg/day prednisone equivalent (within 7-28 days)
  • Active autoimmune disease or GVHD (>Grade II acute or active chronic)
  • Psychiatric or social situations limiting compliance
  • Hypersensitivity to study agents or related compounds

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT06907485

A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration

Organization/Sponsor: University of Pittsburgh


Example patient: A 9-year-old boy with newly diagnosed pilocytic astrocytoma on MRI requiring surgical resection, with normal blood counts and organ function, no history of porphyria, and able to swallow oral medication.

Phase N/A

Interventions

  • Drug: Aminolevulinic acid hydrochloride
    Summary: A porphyrin precursor converted to protoporphyrin IX that accumulates in tumor cells and fluoresces under specific light wavelengths, enabling visualization during surgical resection of brain tumors (FDA label, NCI Thesaurus).

Key Inclusion

  • New or recurrent primary pediatric brain tumor requiring resection
  • Age 2-17 years and 182 days
  • Various tumor types including astrocytoma, ependymoma, medulloblastoma, PNET, ATRT
  • Normal organ and marrow function
  • Leukocytes >3,000/mL and platelets >100,000/mL
  • Ability to swallow 5-ALA solution
  • Written informed consent from guardian

Key Exclusion

  • Unable to swallow 5-ALA solution
  • Radiographic tumors of the brain stem
  • History of allergic reactions to 5-ALA or similar compounds
  • Personal or family history of porphyria
  • Pregnant or breastfeeding
  • Uncontrolled infection or cardiac disease
  • Prior history of GI perforation, diverticulitis, or peptic ulcer disease

NCT07246590

COVE-2: A Phase 3, Double-blind, Randomized, Vehicle-controlled Study to Evaluate the Efficacy and Safety of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris)

Organization/Sponsor: Verrica Pharmaceuticals Inc.


Example patient: A 7-year-old immunocompetent boy with three common warts on his hands, no history of wart treatment in the past 90 days, and no systemic medical conditions.

Phase 3

Interventions

  • Drug: VP-102
    Summary: VP-102 is a topical cantharidin-based drug for treating common warts and molluscum contagiosum, applied directly to wart lesions (Source: Web Search).
  • Drug: Vehicle
    Summary: A substance used as a medium for pharmaceutical administration, serving as placebo control (Source: NCI Thesaurus).

Key Inclusion

  • Male or female patients ≥2 years of age
  • Immunocompetent
  • Minimum of 1 treatable common wart (verruca vulgaris) of any size and height
  • Common warts located anywhere except eye area, lips, oral cavity, nasal cavity, inside ears, soles of feet, subungual spaces, or anogenital area
  • No systemic or dermatologic disorder interfering with study results
  • Agree to refrain from swimming or bathing until study drug removed after each treatment
  • Agree not to use any other wart-removing products during study
  • Provide written informed consent or assent

Key Exclusion

  • Plantar warts, external genital warts, subungual warts, or warts within 10 mm of mucosal surface
  • Systemically immunosuppressed or systemic immunosuppressive medication within 30 days
  • Previous treatment of common warts within 90 days before treatment
  • More common warts than can be covered with 2 study drug applicators (approximately 3000 mm²)
  • Active malignancy or undergoing treatment for any malignancy
  • Epidermodysplasia verruciformis
  • Hypersensitivity to study drug or excipients
  • Pregnant or breastfeeding

NCT07188532

Biologically-Adapted, Dose-Escalated Accelerated Radiotherapy for Ewing Sarcoma (BEAR) Genomic-based

Organization/Sponsor: Mayo Clinic


Example patient: A 12-year-old with newly diagnosed skeletal Ewing sarcoma of the femur, Karnofsky score 80, no prior cancer treatment, willing to provide tumor biopsy and blood samples for genomic profiling.

Phase N/A

Interventions

  • Radiation: Radiation Therapy
    Summary: Exposure of target tissue to radiation for curative or palliative cancer treatment, often combined with other therapies (NCI Thesaurus).
  • Procedure: Questionnaire Administration
    Summary: Collection of patient-reported data through structured questionnaires for outcome assessment (NCI Thesaurus).
  • Diagnostic: Positron Emission Tomography
    Summary: Imaging using positron-emitting radionuclides attached to metabolically active substances to detect gamma radiation and reveal tissue metabolic activity (NCI Thesaurus).
  • Diagnostic: Magnetic Resonance Imaging
    Summary: Imaging using radiofrequency waves and magnetic fields to provide detailed pictures of organs and tissues for diagnosing cancer and other conditions (NCI Thesaurus).
  • Radiation: Hypofractionated Radiation Therapy
    Summary: Radiation treatment using larger doses per fraction delivered less frequently than daily (NCI Thesaurus).
  • Radiation: External Beam Radiation Therapy
    Summary: Delivery of high-energy radiation beams to tumors from outside the body (NCI Thesaurus).
  • Procedure: Electronic Health Record Review
    Summary: Assessment and analysis of data contained in electronic health records for research purposes (NCI Thesaurus).
  • Radiation: Dose-escalated Radiation Therapy
    Summary: Radiation therapy using higher doses than conventional treatment to improve tumor control (NCI Thesaurus).
  • Procedure: Definitive Surgical Resection
    Summary: Surgical removal of tumor chosen as optimal treatment considering all therapeutic options (NCI Thesaurus).
  • Radiation: Conventional Radiotherapy
    Summary: Radiotherapy using minimal imaging support such as X-ray films for positioning (NCI Thesaurus).
  • Diagnostic: Computed Tomography
    Summary: X-ray imaging with computer reconstruction to create cross-sectional body scans (NCI Thesaurus).
  • Drug: Chemotherapy
    Summary: Use of synthetic or natural chemicals for disease treatment, particularly cancer (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Gathering of biological samples for testing, diagnostic, or research purposes (NCI Thesaurus).

Key Inclusion

  • Histological confirmation of Ewing sarcoma (skeletal or extra-skeletal)
  • Age ≥ 2 years
  • Lansky or Karnofsky performance status ≥ 70
  • Willing to provide blood samples for correlative research
  • Cohort A: Willing to provide biopsy for Mayo Complete Solid Tumor Panel

Key Exclusion

  • Prior chemotherapy or radiotherapy interfering with current treatment
  • Receiving investigational agent for primary neoplasm
  • Other active malignancy ≤ 1 year prior to registration
  • Severe co-morbid systemic illness interfering with treatment
  • Active uncontrolled infection or symptomatic heart failure
  • Pregnant or nursing patients

NCT07032545

Metabotyping of a Functional Food, Broccoli Microgreen, in Obese Breast Cancer Survivors

Organization/Sponsor: University of Maryland, Baltimore


Example patient: A 52-year-old obese female with Stage II breast cancer, 18 months post-chemotherapy and radiation, BMI 34 kg/m², no GI conditions or cruciferous vegetable allergies.

Phase N/A

Interventions

  • Dietary Supplement: Broccoli microgreen (BMG)
    Summary: Broccoli microgreen is a nutrient-rich plant with antioxidant and anti-inflammatory properties targeting obesity and inflammation in breast cancer survivors (Source: Web Search).

Key Inclusion

  • Female
  • Diagnosis of breast cancer (Stage I-III)
  • 2 to 60 months post-curative treatment (surgery, chemotherapy, and/or radiation)
  • BMI > 30 kg/m² (obese classification)
  • Willing to avoid cruciferous vegetables during the study

Key Exclusion

  • Contraindications to nutrition intervention (GI conditions, medication requirements, pregnancy, breastfeeding, eating disorder history)
  • Allergy or intolerance to cruciferous vegetables
  • Currently taking broccoli extract supplements

NCT07197554

A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies

Organization/Sponsor: SEED Therapeutics, Inc.


Example patient: A 17-year-old with metastatic Ewing sarcoma, ECOG status 1, with measurable lung lesions, adequate organ function, no prior RBM39 inhibitors, and resolved prior chemotherapy toxicities.

Phase 1

Interventions

  • Drug: ST-01156
    Summary: ST-01156 is a small molecule RBM39 degrader that targets undruggable proteins by inducing degradation of RBM39, a splicing factor, for treatment of advanced solid malignancies including Ewing sarcoma; has orphan drug status (Source: Web Search).

Key Inclusion

  • Age ≥18 years, or ≥16 years for Ewing sarcoma or malignancies with biological rationale
  • Metastatic or locally advanced and unresectable solid tumor
  • At least 1 measurable lesion or evaluable disease per RECIST v1.1
  • ECOG performance status ≤2
  • Adequate organ function

Key Exclusion

  • Prior radiotherapy within 2 weeks of treatment
  • Known active CNS metastases or carcinomatous meningitis
  • Anticancer therapy or investigational agent within 14 days or 5 half-lives
  • Major surgery within 28 days
  • Unresolved toxicities from prior anticancer therapies except alopecia and peripheral neuropathy
  • Previously received RBM39 inhibitor or degrader

NCT05555550

Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)

Organization/Sponsor: Children's Hospital of Philadelphia


Example patient: A 9-year-old child with NF1 and a 2 cm brainstem low-grade glioma, Lansky score 60, weighing 25 kg, starting carboplatin and vincristine therapy.

Phase N/A

Interventions

  • Diagnostic Agent: 18F-Fluciclovine
    Summary: A synthetic L-leucine analogue radiolabeled with fluorine F-18 that enters tumor cells via L-type amino acid transporters and accumulates without metabolism, enabling PET imaging of tumors with increased metabolic needs (NCI Thesaurus, FDA label).

Key Inclusion

  • Low grade glioma WHO grade I-II brainstem or supratentorial
  • Evaluable disease at least 1x1 cm on MRI
  • Scheduled to receive systemic therapy for LGG
  • Karnofsky ≥50 if >16 years or Lansky ≥50 if ≤16 years
  • Age 1 to 21 years at registration
  • Biopsy confirmed unless NF1 with classic appearance

Key Exclusion

  • Inability to tolerate imaging procedures
  • Pregnant participants
  • Weight less than 8 kg
  • Cannot avoid contact with pregnant women or infants for 12 hours post-injection
  • Abnormal kidney function or creatinine ≥CTCAE grade 2
  • Primary spinal cord tumors

NCT06910124

Alpe d'Huez Study: A Parallel Two-Cohort Study of Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse Genomic-based

Organization/Sponsor: University of Miami


Example patient: A 58-year-old with newly-diagnosed multiple myeloma who achieved VGPR after induction therapy with bortezomib-lenalidomide-dexamethasone followed by autologous stem cell transplant, currently on lenalidomide maintenance for 8 months but remains MRD-positive by NGS testing.

Phase N/A

Interventions

  • Drug: Lenalidomide
    Summary: Lenalidomide is a thalidomide analog immunomodulatory agent that inhibits TNF-alpha, stimulates T cells, reduces VEGF and bFGF, inhibits angiogenesis, and promotes G1 arrest and apoptosis in malignant cells. It is indicated for multiple myeloma treatment with dexamethasone and carries significant teratogenic risk requiring REMS program adherence. Source: FDA label, NCI Thesaurus.
  • Biological: Linvoseltamab
    Summary: Linvoseltamab-gcpt is a BCMA-directed CD3 T-cell engaging bispecific antibody that bridges BCMA-expressing tumor cells to cytotoxic T-lymphocytes, promoting CTL-mediated killing of malignant plasma cells. It is indicated for relapsed/refractory multiple myeloma after four prior therapies under accelerated approval. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • Newly-diagnosed multiple myeloma per IMWG criteria
  • Received triplet or quadruplet therapy with IMiD, PI, and/or anti-CD38
  • Receiving lenalidomide maintenance therapy ≤12 months
  • Cohort 1: PR, VGPR, or CR but MRD+ by NGS clonoseq assay
  • Cohort 2: Relapse from CR post-induction but not meeting IMWG progression criteria
  • ECOG Performance Status ≤3
  • ANC ≥1000/µL, platelets ≥50,000/µL, hemoglobin ≥8 g/dL
  • Adequate hepatic and renal function

Key Exclusion

  • Prior systemic MM therapies other than initial IMiD/PI/anti-CD38/HDM-ASCT combination
  • Receiving other investigational agents unless approved by PI
  • HIV-positive with AIDS-defining conditions or detectable viral load
  • Active hepatitis B or hepatitis C infection
  • NYHA stage III/IV heart failure or MI within 3 months
  • Active infection or uncontrolled intercurrent illness within 2 weeks
  • History of seizure within 12 months unless deemed low risk
  • Active malignancy other than MM requiring treatment in past 6 months

NCT07186192

Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor-T Cell (CAR-T)Therapy

Organization/Sponsor: City of Hope Medical Center


Example patient: A 52-year-old adult with relapsed diffuse large B-cell lymphoma scheduled for outpatient CAR-T therapy with a spouse committed to living with them during the study period.

Phase N/A

Interventions

  • Behavioral: Best Practice
    Summary: Standard of care treatment recommendations expected to benefit the greatest number of patients within a specific group (NCI Thesaurus).
  • Behavioral: Questionnaire Administration
    Summary: Administration of questionnaires to collect patient-reported data and outcomes (NCI Thesaurus).
  • Device: Health Telemonitoring
    Summary: Remote monitoring of patient health status using video, audio, and telecommunication methods from a distant site (NCI Thesaurus).
  • Behavioral: Educational Intervention
    Summary: Educational activities designed to prevent disease or alter disease course in patients or populations (NCI Thesaurus).

Key Inclusion

  • Age ≥ 18 years old
  • Relapsed or refractory hematologic malignancy
  • Scheduled to receive outpatient standard of care CAR-T therapy
  • Has a family caregiver committed to living with patient during study
  • Ability to read and understand English or Spanish
  • Documented informed consent

Key Exclusion

  • Employee under direct/indirect supervision of PI or co-investigator
  • Direct study team member

NCT06465199

A Dose Escalation Study Using Eflornithine (DFMO) and AMXT 1501 Followed by a Randomized Controlled Trial of DFMO With or Without AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas

Organization/Sponsor: Milton S. Hershey Medical Center


Example patient: A 15-year-old with relapsed high-risk neuroblastoma after multi-agent chemotherapy and immunotherapy, currently stable on salvage therapy with bone marrow involvement <40%, performance score of 70, and normal cardiac and renal function.

Phase 1, Phase 2

Interventions

  • Drug: AMXT 1501 Dicaprate
    Summary: Orally bioavailable polyamine transport inhibitor that blocks polyamine uptake into tumor cells, decreasing intratumoral polyamine concentrations, inhibiting proliferation, inducing apoptosis, and potentially reversing immune suppression in the tumor microenvironment (NCI Thesaurus).
  • Drug: Eflornithine (DFMO)
    Summary: Irreversibly inhibits ornithine decarboxylase, blocking polyamine biosynthesis required for tumor cell formation and proliferation, and inducing apoptosis by disrupting chromatin environments that promote neoplastic transformation (NCI Thesaurus).

Key Inclusion

  • Maximum 21 years of age at diagnosis
  • Relapsed/refractory neuroblastoma, ETMR, ATRT, Ewing sarcoma, or osteosarcoma; or newly diagnosed DIPG
  • DIPG subjects must start >30 and ≤60 days after standard radiation therapy
  • Subjects with active disease must have stable disease or better on recent treatment
  • Able to swallow capsules
  • Lansky or Karnofsky Performance Scale ≥60
  • Adequate organ function including ANC ≥750/μL, normal cardiac troponin and BNP, QTcF ≤470 msec
  • eGFR ≥70 mL/min/1.73 m2

Key Exclusion

  • BSA <0.25 m2
  • Currently receiving other investigational drugs or anticancer agents
  • Uncontrolled infection
  • DIPG subjects with progression or recurrence after initial radiation
  • Subjects with metastatic DIPG
  • Pregnant or lactating subjects without agreement to stop breastfeeding
  • Unable to comply with safety monitoring requirements
  • Active graft versus host disease if prior allogeneic transplant

NCT07196644

A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification Genomic-based

Organization/Sponsor: AbbVie


Example patient: A 58-year-old with metastatic gastric cancer harboring MET amplification confirmed by FoundationOne CDx, ECOG status 1, with stable brain metastases after radiation, who progressed on standard chemotherapy.

Phase 2

Interventions

  • Drug: Telisotuzumab Adizutecan
    Summary: An antibody-drug conjugate targeting c-Met receptor with a topoisomerase inhibitor payload. Upon binding c-Met on tumor cells, the ADC is internalized and releases the topoisomerase inhibitor, blocking DNA replication and killing cancer cells. Source: NCI Thesaurus.

Key Inclusion

  • Locally advanced or metastatic solid tumors with documented MET amplification
  • MET amplification confirmed by local NGS or FoundationOne CDx
  • ECOG Performance Status 0 to 1
  • Measurable disease per RECIST v1.1 or RANO criteria
  • Received prior systemic therapy with no satisfactory alternative
  • CNS metastases must be asymptomatic or radiologically stable

Key Exclusion

  • Current, historical, or suspected interstitial lung disease or pneumonitis requiring steroids
  • Life expectancy less than 12 weeks
  • Major life-threatening conditions

NCT07220993

Novel Unedited Allo Cell Therapy For High Risk T-Cell Malignancies Using CD7-Specific Car Expressed On T Cells (NEO-CRIMSON)

Organization/Sponsor: Baylor College of Medicine


Example patient: A 42-year-old with relapsed T-ALL 90 days post-haploidentical HSCT, CD7-positive disease by flow cytometry, Karnofsky score 70%, no active GVHD, and original donor available for CAR T-cell manufacturing.

Phase N/A

Interventions

  • Biological: CD7.CAR/28zeta T Cells
    Summary: Allogeneic T-lymphocytes engineered to express a CD7-directed CAR with CD28 and CD3-zeta costimulatory domains, targeting CD7-expressing tumor cells for lysis in T-cell leukemias and lymphomas (NCI Thesaurus).

Key Inclusion

  • Recurrent T-ALL, T-LL, or T-NHL with ≥20% CD7-positive tumor cells
  • Relapsed post-allogeneic related donor HSCT
  • Prior allogeneic donor available for CD7.CAR T-cell manufacture
  • Suitable for allogeneic HSCT with suitable donor identified
  • Age ≤75 years
  • ≥60 days post-allogeneic HSCT at treatment
  • Karnofsky or Lansky score ≥60%
  • Available partially-HLA matched EBV-specific T cell line

Key Exclusion

  • Active GVHD >Grade II or chronic GVHD >mild severity
  • Corticosteroids >0.5mg/kg prednisone equivalent
  • Immunosuppressive treatment for GVHD within 28 days
  • Uncontrolled viral reactivation (EBV, CMV, Adv, BK, HHV-6)
  • CNS-3 disease or CNS abnormalities
  • LVEF <50% or cardiac dysfunction NYHA III/IV
  • Pregnant or lactating
  • Tumor location risking airway obstruction

NCT07076498

Phase 1 Trial of Engineered HSV-1 M032 in Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation Genomic-based

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 5-year-old child with newly diagnosed H3 K27M-mutant diffuse midline glioma of the pons, 6 weeks post-radiation, with a 2.5 cm surgically accessible tumor and Lansky score of 70.

Phase 1

Interventions

  • Biological: M032
    Summary: M032 is a genetically engineered oncolytic HSV-1 with ICP34.5 deletion expressing IL-12. It selectively replicates in tumor cells causing viral lysis and promotes immune activation via IL-12 secretion, activating NK cells and CTL responses against tumor cells. Source: NCI Thesaurus.

Key Inclusion

  • Age ≥ 36 months
  • Newly diagnosed diffuse midline glioma H3 K27M mutant or pontine DMG
  • Received standard radiation 4-8 weeks prior to enrollment
  • Tumor 1.0-4.0 cm diameter and surgically accessible
  • Lansky score ≥ 60 (age <16) or Karnofsky ≥ 60 (age ≥16)
  • Adequate hematologic, renal, and liver function
  • No immunosuppressive therapy including corticosteroids at enrollment
  • Recovered from acute treatment-related toxicities

Key Exclusion

  • Previously received other investigational agents
  • Untreated symptomatic hydrocephalus
  • Primary spinal cord tumor
  • Pregnant or lactating females
  • Active herpes infection with symptoms
  • Known HIV or immune deficiency
  • Concurrent antiviral therapy against HSV
  • Live vaccine within 30 days prior to treatment

NCT07222735

Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas

Organization/Sponsor: St. Jude Children's Research Hospital


Example patient: A 14-year-old with relapsed osteosarcoma expressing B7-H3 after completing first-line chemotherapy, with lung metastases amenable to radiation and performance score of 70.

Phase N/A

Interventions

  • Radiation: Radiation Therapy
    Summary: Hypofractionated radiation therapy targeting tumor lesions to enhance CAR T cell efficacy; involves exposure of target tissue to radiation for curative or palliative cancer treatment (NCI Thesaurus).
  • Biological: B7-H3-CAR T Cells
    Summary: Autologous CAR T cells engineered to target B7-H3 (CD276), a tumor-associated antigen expressed on sarcomas; designed to recognize and kill B7-H3-positive cancer cells (NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Alkylating agent used for lymphodepletion prior to CAR T cell infusion; converted to active metabolites that cross-link DNA, inhibiting replication and causing cell death (FDA label, NCI Thesaurus).
  • Drug: Fludarabine
    Summary: Fluorinated nucleoside analog for lymphodepletion; inhibits DNA synthesis via fludarabine triphosphate, blocking DNA polymerase and primase to suppress immune cells before CAR T infusion (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≤21 years old
  • B7-H3+ sarcoma (osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or non-rhabdomyosarcoma soft tissue sarcoma) with H score ≥100
  • Relapsed or refractory disease after standard first-line therapy
  • At least one lesion amenable to hypofractionated radiation therapy
  • Karnofsky or Lansky performance score ≥60
  • Adequate cardiac function (LVEF ≥50%)
  • Adequate renal, hepatic, and pulmonary function
  • Recovered from grade III-IV non-hematologic acute toxicities

Key Exclusion

  • Known primary immunodeficiency or HIV positivity
  • Severe uncontrolled bacterial, viral, or fungal infection
  • Active malignancy other than B7-H3+ sarcoma being treated
  • Rapidly progressive disease near critical structures
  • Presence of intracranial or spinal cord disease
  • Systemic steroid therapy >0.5 mg/kg/day methylprednisolone equivalent within 7 days of CAR T infusion
  • Systemic therapy within 14 days that interferes with CAR product activity
  • Radiation therapy within 4 weeks prior to protocol therapy start

NCT07091617

AYA Access Study: An Enhanced eHealth and Chat-Bot Enabled Delivery Model for Clinical Genetic Services in Community AYA Cancer Patients Genomic-based

Organization/Sponsor: Alliance for Clinical Trials in Oncology


Example patient: A 28-year-old Spanish-speaking woman with newly diagnosed BRCA-positive metastatic breast cancer who meets NCCN guidelines for genetic testing and has no cognitive impairment.

Phase N/A

Interventions

  • Procedure: Telemedicine
    Summary: Uses telecommunications technology to provide or enhance health care services by accessing databases, linking clinics to hospitals, or transmitting diagnostic images remotely (NCI Thesaurus).
  • Diagnostic Test: Genetic Testing
    Summary: Isolates and tests DNA to detect genetic alterations or defects that may predispose to future disease development (NCI Thesaurus).
  • Behavioral: Internet-Based Intervention
    Summary: Program using the internet to alter, modify, or eliminate a behavior (NCI Thesaurus).
  • Behavioral: Educational Intervention
    Summary: Educational activity intended to prevent disease or alter disease course in a patient or population (NCI Thesaurus).
  • Other: Patient Navigation
    Summary: Healthcare service designed to guide patients through the healthcare system and reduce barriers to timely screening, diagnosis, treatment, and supportive care (NCI Thesaurus).
  • Other: Interview
    Summary: Conversation regarding background, personal and professional details, and opinions on specific subjects posed by the interviewer (NCI Thesaurus).
  • Other: Survey Administration
    Summary: Presenting a survey, questionnaire, or similar item to a person to obtain their responses (NCI Thesaurus).

Key Inclusion

  • Age 18-39 years at enrollment
  • AYA cancer patients and survivors with diagnosis at any age ≤39 years
  • Any stage of diagnosis including newly diagnosed, in treatment, or survivorship
  • Able to speak and read English or Spanish
  • Meet NCCN guidelines for genetic testing assessment
  • Includes patients with metastatic cancer (BRCA+, MSI-high/Lynch Syndrome)

Key Exclusion

  • Known diagnosis of dementia or cognitive impairment
  • Impaired decision-making capacity
  • Psychiatric or developmental disorder affecting cognitive or emotional functions significantly
  • Unable to understand genetic test results and implications for patient and family

NCT06701812

Evaluation of Digoxin for Relapsed Non-WNT, Non-SHH Medulloblastoma Genomic-based

Organization/Sponsor: H. Lee Moffitt Cancer Center and Research Institute


Example patient: A 7-year-old child with relapsed Group 3 medulloblastoma confirmed by methylation profiling, previously treated with chemotherapy and craniospinal radiation, now with measurable spinal metastases and stable neurologic function.

Phase N/A

Interventions

  • Drug: Digoxin
    Summary: Digoxin is a cardiac glycoside that inhibits sodium-potassium ATPase, increasing intracellular calcium to enhance cardiac contractility and slow AV node conduction. In cancer, it induces tumor cell apoptosis via mitochondrial cytochrome c and caspases 8 and 3. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • Age >12 months and <30 years
  • Relapsed non-WNT, non-SHH medulloblastoma confirmed by CAP/CLIA certified assay
  • At least one prior course of chemotherapy and irradiation
  • Measurable residual disease on MRI (at least 2 times slice thickness)
  • Lansky or Karnofsky performance status ≥50%
  • Normal organ and marrow function
  • No evidence of Wolff-Parkinson-White syndrome or high-grade AV block
  • Stable neurologic status for ≥7 days prior to enrollment

Key Exclusion

  • Receiving concurrent anticancer or investigational agents
  • Taking digoxin during treatment for initial diagnosis or relapse
  • History of allergic reactions to digoxin or similar compounds
  • Serious or inadequately controlled cardiac arrhythmias
  • Taking medications that interfere with digoxin metabolism
  • Uncontrolled intercurrent illness or significant organ dysfunction
  • Pregnant or unwilling to stop breastfeeding
  • Psychiatric illness or social situations limiting compliance

NCT06771830

A Rapid Diagnostic of Risk in Hospitalized Pediatric Patients to Improve Outcomes Using Machine Learning

Organization/Sponsor: University of Wisconsin, Madison


Example patient: A 7-year-old hospitalized patient with acute respiratory distress being monitored with the eCART system to predict risk of clinical deterioration.

Phase N/A

Interventions

  • Clinical Decision Support Tool: Pediatric eCART
    Summary: Pediatric eCART is a machine learning clinical decision support tool that analyzes electronic health record data to identify hospitalized children under 18 at high risk for life-threatening outcomes such as cardiac arrest (Source: Web Search).

Key Inclusion

  • Pediatric patients under 18 years of age
  • Eligible for pediatric eCART scoring
  • Inpatient locations
  • UW Health nurses who interact with eCART during patient care

Key Exclusion

  • Patients ineligible for pediatric eCART scoring
  • Neonates and birth encounters
  • UW Health nurses no longer employed at UW Health

NCT07147179

Pilot Trial of Short Course Radiotherapy for Primary or Secondary CNS Malignancies

Organization/Sponsor: Abramson Cancer Center at Penn Medicine


Example patient: A 15-year-old with metastatic osteosarcoma to the brain with multiple intracranial lesions, Lansky score 50, requiring palliative radiation after prior systemic therapy failure.

Phase N/A

Interventions

  • Radiation: Short Course Radiotherapy
    Summary: Chemoradiotherapy delivering 25 Gy in 5 fractions over 1 week with concomitant chemotherapy as radiosensitizer for palliative CNS malignancies (NCI Thesaurus).

Key Inclusion

  • Age 21 years or below
  • Lansky performance status >= 40
  • Incurable malignancy metastatic to brain or recurrent within brain
  • At least 1 targetable intracranial lesion on imaging
  • Multidisciplinary consensus for palliative intent radiation
  • Prior radiation in planned treatment area allowed

Key Exclusion

  • Radiotherapy for curative intent
  • Serious uncontrolled systemic or psychiatric disorders
  • Planned for proton radiation

NCT05676489

MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors

Organization/Sponsor: University of Alabama at Birmingham


Example patient: A 52-year-old male with recurrent grade IV glioblastoma previously treated with radiation, presenting with a 1.5-cm enhancing lesion on MRI, ECOG performance status 1, and normal renal function.

Phase N/A

Interventions

  • Diagnostic: [F-18]MeFAMP PET
    Summary: A radioconjugate of non-natural amino acid MeFAMP labeled with fluorine F-18 for PET imaging. Selectively taken up by tumor cells via amino acid transport system due to increased protein synthesis, accumulates without incorporation into proteins, enabling visualization of rapidly proliferating cancer cells. Source: NCI Thesaurus.

Key Inclusion

  • 18 years of age or older
  • Life expectancy greater than 12 weeks
  • Grade III or IV glioma previously treated with radiation (HGG cohort)
  • Enhancing lesion at least 1-cm suspicious for recurrent glioma (HGG cohort)
  • At least one brain metastasis from melanoma, lung, or breast cancer measuring 1-cm or greater (Metastasis cohort)
  • Plan for stereotactic radiation therapy within 2 weeks (Metastasis cohort)
  • ECOG performance score of 2 or better (HGG and Metastasis cohorts)
  • Normal CMP, CBC, and ECG at baseline (Dosimetry cohort)

Key Exclusion

  • Use of investigational drug within 3 months prior
  • Pregnancy or breast feeding
  • Inability to complete PET scans
  • Significant renal or hepatic dysfunction (GFR < 60 mL/min)
  • Major medical problems interfering with biodistribution (Dosimetry cohort)

NCT07194044

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes Genomic-based

Organization/Sponsor: H. Lee Moffitt Cancer Center and Research Institute


Example patient: A 14-year-old with newly diagnosed widely metastatic Ewing sarcoma involving bone and liver who has started one cycle of vincristine, doxorubicin, and cyclophosphamide, with adequate organ function and tissue available for molecular testing.

Phase N/A

Interventions

  • Drug: Liposomal doxorubicin
    Summary: Liposomal anthracycline topoisomerase II inhibitor that prevents DNA replication by stabilizing topoisomerase-DNA complexes; indicated for platinum-resistant ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma; requires monitoring for cardiotoxicity and myelosuppression (FDA label, NCI Thesaurus).
  • Drug: Etoposide
    Summary: Semisynthetic podophyllotoxin derivative and topoisomerase II inhibitor that causes DNA strand breaks and prevents replication; indicated for refractory testicular tumors and small cell lung cancer; acts primarily in G2 and S phases (FDA label, NCI Thesaurus).
  • Drug: Temozolomide
    Summary: Oral alkylating agent that converts to MTIC, methylating DNA at O6 and N7 guanine positions; indicated for glioblastoma and anaplastic astrocytoma; penetrates CNS well; requires monitoring for myelosuppression and secondary malignancies (FDA label, NCI Thesaurus).
  • Drug: Topotecan
    Summary: Semisynthetic camptothecin derivative and topoisomerase I inhibitor that stabilizes enzyme-DNA complexes during S phase, producing lethal double-strand breaks; indicated for small cell lung cancer and cervical cancer with cisplatin (FDA label, NCI Thesaurus).
  • Drug: Cabozantinib
    Summary: Oral multi-kinase inhibitor targeting MET, RET, VEGFR 1-3, KIT, FLT-3, TIE-2, TRKB, and AXL; inhibits tumor growth and angiogenesis; indicated for progressive metastatic medullary thyroid cancer (FDA label, NCI Thesaurus).
  • Drug: Irinotecan
    Summary: Camptothecin prodrug converted to SN-38, a topoisomerase I inhibitor 1000-fold more potent than parent compound; stabilizes topoisomerase-DNA complex causing breaks; indicated for metastatic colorectal cancer; S-phase specific agent (FDA label, NCI Thesaurus).
  • Drug: Actinomycin
    Summary: Chromopeptide antibiotic from Streptomyces that intercalates into DNA minor groove and inhibits topoisomerase II; indicated for Wilms tumor, rhabdomyosarcoma, Ewing sarcoma, testicular cancer, and gestational trophoblastic neoplasia in combination regimens (FDA label, NCI Thesaurus).
  • Drug: Ifosfamide
    Summary: Nitrogen mustard analog and alkylating prodrug activated by hepatic hydroxylation; forms DNA crosslinks preventing strand separation and replication; indicated for third-line germ cell testicular cancer; requires concurrent mesna to prevent hemorrhagic cystitis (FDA label, NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Nitrogen mustard alkylating agent converted in liver to active metabolites that bind DNA, inhibiting replication; indicated for lymphomas, leukemias, breast and ovarian cancers, and pediatric minimal change nephrotic syndrome; requires monitoring for hemorrhagic cystitis and myelosuppression (FDA label, NCI Thesaurus).
  • Drug: Doxorubicin
    Summary: Anthracycline antibiotic from Streptomyces that intercalates DNA and inhibits topoisomerase II, preventing replication; also generates oxygen free radicals; indicated for breast cancer, leukemias, lymphomas, and solid tumors; dose-dependent cardiotoxicity requires monitoring (FDA label, NCI Thesaurus).
  • Drug: Vincristine
    Summary: Vinca alkaloid from Vinca rosea that binds microtubules irreversibly, disrupting mitotic spindle formation and arresting cells in metaphase; indicated for acute leukemia, Hodgkin's and non-Hodgkin's lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor (FDA label, NCI Thesaurus).

Key Inclusion

  • Age >1 year
  • Widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma
  • New histologic diagnosis
  • Sufficient tissue for correlative testing (flash frozen, FFPE block, or unstained slides)
  • May have started initial VDC cycle but not ifosfamide/etoposide
  • Adequate organ function
  • Contraception agreement for reproductive-age patients
  • Ability to provide informed consent or assent

Key Exclusion

  • Localized disease or lung-only metastases for Ewing sarcoma
  • CNS tumors (primary or metastatic)
  • Receiving other investigational cancer agents
  • History of cancer treated with myelosuppressive chemotherapy or radiation
  • Receiving additional medicines for cancer treatment
  • Uncontrolled intercurrent illness
  • Pregnancy or breastfeeding
  • Unable to comply with safety monitoring

NCT07226102

An E-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer

Organization/Sponsor: City of Hope Medical Center


Example patient: A 52-year-old English-speaking woman with stage III triple negative breast cancer diagnosed 4 months ago, currently in remission but experiencing severe fear of cancer progression with a Fear of Progression score of 38.

Phase N/A

Interventions

  • Behavioral: Virtual Technology Intervention
    Summary: Uses an immersive, computer-generated environment for interaction and navigation to address fear of cancer progression (NCI Thesaurus).
  • Procedure: Survey Administration
    Summary: Presents surveys and questionnaires to obtain patient responses for assessment purposes (NCI Thesaurus).
  • Procedure: Interview
    Summary: Structured conversation to gather background, personal details, and opinions from participants (NCI Thesaurus).
  • Behavioral: Internet-Based Intervention
    Summary: Uses internet-delivered programs to modify or eliminate maladaptive behaviors related to fear of progression (NCI Thesaurus).
  • Behavioral: Educational Intervention
    Summary: Educational activities intended to prevent disease or alter disease course in cancer patients (NCI Thesaurus).
  • Behavioral: Behavioral Intervention
    Summary: Uses operant conditioning with rewards and punishments to help patients reduce contribution to painful stimuli (NCI Thesaurus).

Key Inclusion

  • Women with stage III or IV gynecologic or breast cancer
  • At least 2 months from initial diagnosis
  • High-risk disease including carcinosarcoma, triple negative breast cancer
  • Fear of Progression Short-Form score ≥34 indicating dysfunctional levels
  • Age 18 or older
  • Able to read and understand English
  • Patients in remission or with progressive disease

Key Exclusion

  • Enrolled in hospice
  • Major depression as assessed by PHQ-9
  • Non-English speaking
  • Unable to comply with study procedures

NCT07257419

CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+ T Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma

Organization/Sponsor: St. Jude Children's Research Hospital


Example patient: A 14-year-old with high-risk CD19+ B-cell ALL in second complete remission with adequate cardiac and renal function, no matched sibling donor available, and a haploidentical parent donor.

Phase N/A

Interventions

  • Device: CliniMACS System
    Summary: A proprietary flow cytometry system using anti-CD34 antibodies to isolate CD34+ cells from apheresis specimens for cell processing (NCI Thesaurus).
  • Biological: Filgrastim
    Summary: Recombinant human granulocyte colony-stimulating factor that stimulates neutrophil production and release from bone marrow to prevent chemotherapy-induced neutropenia and mobilize stem cells (FDA label, NCI Thesaurus).
  • Drug: Melphalan
    Summary: Bifunctional alkylating agent that cross-links DNA at guanine N7 position, inhibiting DNA/RNA synthesis for conditioning prior to transplant (FDA label, NCI Thesaurus).
  • Drug: Mesna
    Summary: Cytoprotective sulfhydryl compound that detoxifies and inactivates urotoxic metabolites of chemotherapy agents to prevent hemorrhagic cystitis (FDA label, NCI Thesaurus).
  • Drug: Thiotepa
    Summary: Alkylating agent converted to reactive ethylenimine groups that cross-link DNA at guanine bases, inducing apoptosis for conditioning chemotherapy (FDA label, NCI Thesaurus).
  • Drug: Fludarabine
    Summary: Fluorinated nucleoside analog that inhibits DNA polymerase, ribonucleotide reductase, and DNA primase to disrupt DNA synthesis for conditioning regimen (FDA label, NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Alkylating agent converted to active metabolites that cross-link DNA, inhibiting replication and providing immunosuppression for transplant conditioning (FDA label, NCI Thesaurus).
  • Biological: Anti-Thymocyte Globulin (Rabbit)
    Summary: Rabbit-derived immunoglobulin that binds T-lymphocyte surface antigens causing T-cell depletion and immunosuppression to prevent graft-versus-host disease (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≤21 years
  • High risk CD19+ B-cell ALL in CR1, CR2, CR3 or subsequent remission
  • Left ventricular ejection fraction >40% or shortening fraction ≥25%
  • Creatinine clearance or GFR ≥50 ml/min/1.73m²
  • Karnofsky or Lansky performance score ≥50
  • At least single haplotype matched (≥4 of 8) family donor
  • Donor at least 18 years of age
  • Prior CNS leukemia must be treated and in CNS CR

Key Exclusion

  • Suitable HLA-identical sibling or 12/12 matched unrelated donor available
  • Any other active malignancy
  • Prior allogeneic HCT at any time
  • Autologous HCT within previous 6 months
  • Pregnant or breast feeding
  • Severe uncontrolled bacterial, fungal or viral infection

NCT06654466

Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing Genomic-based

Organization/Sponsor: Nest Genomics


Example patient: A 32-year-old English-speaking woman receiving care at Dana Farber with a BRCA1 pathogenic variant identified on prior testing, currently cancer-free and not undergoing active treatment.

Phase N/A

Interventions

  • Software Platform: Nest
    Summary: EMR-integrated platform using AI to streamline genomic data management and deliver longitudinal genetics-based care for cancer patients with pathogenic variants. Source: Web Search.

Key Inclusion

  • Ages 18-49 years
  • Pathogenic or likely pathogenic variant from prior cancer genetic testing
  • Increased cancer risk warranting clinical management
  • English-speaking and reading
  • Receiving care at Dana Farber Cancer Institute
  • Not in active cancer therapy at time of approach

Key Exclusion

  • Age less than 18 or greater than 49 years
  • No prior genetic testing for hereditary cancer syndromes
  • Genetic testing with no pathogenic or likely pathogenic variant identified
  • Non-English speaking and reading
  • Not receiving care at Dana Farber Cancer Institute
  • Active cancer with therapy in progress

NCT07102797

ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence

Organization/Sponsor: Massachusetts General Hospital


Example patient: A 10-year-old pre-menarchal girl with BMI at 90th percentile and maternal history of PCOS, without diabetes or cardiac conditions, seeking to improve metabolic health through physical activity.

Phase N/A

Interventions

  • Behavioral: ActiveGirls Physical Activity Program (Delayed Lower Intensity)
    Summary: A delayed, lower-intensity virtual exercise program with personalized routines aimed at improving exercise capacity and well-being in at-risk girls (source: Web Search).
  • Behavioral: ActiveGirls Physical Activity Program (Full)
    Summary: A full-intensity structured physical activity program for girls aged 8-12 targeting hormone health and diabetes risk reduction through exercise routines (source: Web Search).

Key Inclusion

  • Female, ages 8-12 years old
  • Pre-menarchal at baseline
  • At risk for PCOS/insulin resistance
  • History of maternal PCOS or gestational diabetes
  • BMI ≥85th percentile
  • History of premature adrenarche
  • Small for gestational age (<10th percentile)
  • English-speaking child and caregiver

Key Exclusion

  • Taking metformin, GLP-1R agonist, insulin, or GnRH agonist
  • Type 1 or Type 2 diabetes
  • Congenital adrenal hyperplasia or adrenal tumor
  • Growth hormone deficiency
  • Uncontrolled hypothyroidism (TSH >7.0 mIU/mL)
  • Cardiovascular, neurologic, or musculoskeletal conditions limiting physical activity
  • Severe congenital heart disease, cystic fibrosis, cerebral palsy
  • Significant cardiac, hepatic, oncologic, inflammatory, or psychiatric disease

NCT07148050

Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells Genomic-based

Organization/Sponsor: Seattle Children's Hospital


Example patient: A 9-year-old with relapsed GPC3-positive hepatoblastoma after two prior treatment lines, Lansky score 70%, no active infections, and adequate organ function.

Phase N/A

Interventions

  • Biological: SC-CAR.GPC3xIL15.21 CAR T cells
    Summary: CAR T cells targeting GPC3-positive pediatric solid tumors, armored with IL-15 and IL-21 to enhance T-cell activity and proliferation, tested for hepatoblastoma and rhabdomyosarcoma to reduce tumor burden (Web Search).

Key Inclusion

  • Diagnosis of solid tumor expressing GPC3
  • Lansky or Karnofsky score ≥60%
  • Life expectancy >16 weeks
  • Refractory or relapsed disease after upfront therapy and at least one salvage treatment
  • Adequate organ function and laboratory values
  • Recovered from acute toxic effects of prior chemotherapy
  • For hepatocellular carcinoma: Barcelona Liver Cancer Stage A, B or C
  • For hepatocellular carcinoma: Child-Pugh Turcotte Score <7

Key Exclusion

  • History of hypersensitivity to murine protein products or presence of HAMA
  • History of organ transplantation
  • Known HIV positivity
  • Active bacterial, fungal, or viral infection (except Hepatitis B or C)
  • Active autoimmune or inflammatory disorder
  • Pregnancy or lactation
  • Systemic steroid treatment ≥0.5 mg/kg/day prednisone equivalent
  • Congestive heart failure (NYHA Class III or IV) or myocardial infarction within 6 months

NCT06446661

Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Adults With Acute Lymphoblastic Leukemia Using Text Messages

Organization/Sponsor: University of Chicago


Example patient: A 22-year-old with newly diagnosed ALL starting maintenance therapy with mercaptopurine and methotrexate on a CALGB 10403 protocol who owns a cell phone.

Phase N/A

Interventions

  • Behavioral: Low Intensity Text Messaging
    Summary: Daily automated text message reminders sent to patients and caregivers to improve adherence to oral chemotherapy during maintenance therapy (Summary of Web Search).
  • Behavioral: No Text Messaging
    Summary: Control arm with no text message intervention, representing standard communication strategies for patient and family support (Summary of Web Search).
  • Behavioral: High Intensity
    Summary: High-intensity text messaging intervention with increased frequency or content to enhance medication adherence in maintenance therapy (Summary of Web Search).

Key Inclusion

  • Age 15-39 years at initial ALL diagnosis
  • Diagnosed with ALL
  • Receiving pediatric-based regimen with maintenance mercaptopurine and methotrexate
  • Enrollment prior to start of maintenance phase

Key Exclusion

  • Patient or caregiver lacks cell phone that receives text messages
  • Patient does not wish to participate