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Functional Precision Medicine for Recurrent or Refractory Childhood Cancers

This study is looking at a new approach called Functional Precision Medicine (FPM) for children and young adults (up to 21 years old) with recurrent (cancer that has come back) or refractory (cancer that hasn't responded to treatment) acute myeloid leukemia, acute lymphoblastic leukemia, large cell lymphoma, or Hodgkin lymphoma. FPM involves testing your tumor cells with different approved drugs outside the body (ex vivo drug sensitivity testing) and looking at your tumor's genetic makeup (genomic tumor profiling). The goal is to see how often FPM can provide personalized treatment options and recommendations. This study aims to enroll 65 participants from the South Florida area.

Study design
This interventional study plans to enroll 65 participants. It is not specified if it's a randomized or single-arm study.
What's involved
You would need to have a suspected or confirmed diagnosis of recurrent or refractory cancer and be scheduled for or have recently had a biopsy or bone marrow aspirate. You would also need to be willing to have a blood draw or buccal swab.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the percentage of patients who receive FPM-guided treatment options for up to 6 years.

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NCT05857969

Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

Recruiting
PHASE1Ages 1–21InterventionalTreatment
Florida International University
~65 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Functional Precision Medicine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Patients that receive Functional Precision Medicine (FPM)-guided treatment options
Measured over Up to 6 years

Conditions

Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Large Cell Lymphoma
Refractory Childhood Acute Lymphoblastic Leukemia
Refractory Childhood Hodgkin Lymphoma
Refractory Childhood Malignant Germ Cell Neoplasm
Recurrent Childhood Brain Tumor
Recurrent Childhood Brainstem Glioma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Soft Tissue Sarcoma
Recurrent Childhood Ependymoma
Recurrent Childhood Lymphoblastic Lymphoma
Recurrent Childhood Gliosarcoma
Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Refractory Childhood Malignant Solid Neoplasm
Recurrent Childhood Malignant Solid Neoplasm
Recurrent Childhood Malignant Neoplasm
Refractory Childhood Malignant Neoplasm

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Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaBrain NeoplasmBrain Stem GliomaChronic Myeloid Leukemia, BCR-ABL1 PositiveEpendymomaGliosarcomaHematologic NeoplasmHodgkin's GranulomaLarge Cell LymphomaLymphoblastic LymphomaMalignant Germ Cell TumorRhabdomyosarcomaSoft Tissue SarcomaSolid NeoplasmBCR/ABL1 Fusion Gene

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Diana Azzam · PRINCIPAL_INVESTIGATOR · Florida International University
  • Maggie Fader · PRINCIPAL_INVESTIGATOR · Nicklaus Children's Hospital

Who to contact

Diana Azzam, PhD
[email protected]
305-348-9043
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients aged 21 years or younger at the time of enrollment on this study of any gender, race or ethnicity.

Exclusion

Subjects who do not have malignant tissue available and accessible The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.

What this trial measures

  • Percentage of Patients that receive Functional Precision Medicine (FPM)-guided treatment optionsUp to 6 years

    This study will be considered successful (feasibility demonstrated) if it is possible to choose and initiate a monotherapy or combination drug regimen based on functional and/or genomics data within 4 weeks in at least 39 out of 65 patients (60%). To achieve at least 90% power, the null hypothesis will be rejected when at least 39 out of 65 patients receive treatment recommendations through functional and/or genomics data within 4 weeks on the study. With that outcome, we would have 95% confidence that the true feasibility rate is at least 40% (95% CI: 0.4905 to 1).