Recruiting
Phase 1

Observational Study

Sponsor:

Florida International University

Code:

NCT05857969

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

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Functional Precision Medicine

Study Details

Brief summary:

Functional precision medicine (FPM) is a relatively new approach to cancer therapy based on direct exposure of patient- isolated tumor cells to clinically approved drugs and integrates ex vivo drug sensitivity testing (DST) and genomic profiling to determine the optimal individualized therapy for cancer patients. In this study, we will enroll relapsed or refractory pediatric cancer patients with tissue available for DST and genomic profiling from the South Florida area, which is 69% Hispanic and 18% Black. Tumor cells collected from tissue taken during routine biopsy or surgery will be tested.

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

Study ID

NCT05857969

Start date

Feb 22, 2023

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Feb 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers) Subjects willing to have a blood draw or buccal swab done for the purposes of genetic testing Subjects or their parents or legal guardians willing to sign informed consent Subjects aged 7 to 17 willing to sign assent

Exclusion Criteria:

  • 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.

Patients with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Functional Precision Medicine for Chemorefractory or relapsed patients

We intend to enroll chemorefractory or relapsed pediatric patients with all types of cancers where tumor tissue would be available for functional precision medicine that integrates ex vivo drug screening and genomic profiling. The results of the drug sensitivity assay and genetic screening will be used to inform treating physician about patient-specific drug sensitivity or resistance guiding best therapy choices.

Interventions

Functional Precision Medicine

Ex Vivo Drug Sensitivity Testing + Genomic Tumor Profiling

Primary outcome measure

  • Percentage of Patients that receive Functional Precision Medicine (FPM)-guided treatment options [ Time Frame: Up to 6 years ]

Central Contacts and Locations

Central contacts

Diana Azzam, PhD

305-348-9043fpmlab@fiu.edu

Lillian Garvin

800-533-1792exvivotrial@nicklaushealth.org

Locations

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Darika Sartmatova

800-533-1792exvivotrial@nicklaushealth.org

Lillian Garvin

800-533-1792exvivotrial@nicklaushealth.org

More Information

Sponsor

Florida International University

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • ex vivo drug sensitivity assay
  • genomic profiling
  • Functional precision medicine
  • Biomarker development

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Florida International University on 2026-08-26.