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NCT05857969
Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling
Phase 1 trial testing Functional Precision Medicine in Recurrent Childhood Acute Myeloid Leukemia in 65 participants. Currently enrolling.
22 February 2028
Quick facts
| Lead sponsor | Florida International University |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 22 February 2023 |
| Primary completion | 22 February 2028 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Functional Precision Medicine
Conditions studied
- Recurrent Childhood Acute Myeloid Leukemia — all drugs for Recurrent Childhood Acute Myeloid Leukemia →
- Recurrent Childhood Acute Lymphoblastic Leukemia — all drugs for Recurrent Childhood Acute Lymphoblastic Leukemia →
- Recurrent Childhood Large Cell Lymphoma — all drugs for Recurrent Childhood Large Cell Lymphoma →
- Refractory Childhood Acute Lymphoblastic Leukemia — all drugs for Refractory Childhood Acute Lymphoblastic Leukemia →
Sponsor
Florida International University
Who can join
Adults 1 Day to 21, any sex, with Recurrent Childhood Acute Myeloid Leukemia or Recurrent Childhood Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Feasibility of functional precision medicine for guiding treatment of relapsed or refractory pediatric cancers.
Acanda De La Rocha AM, Berlow NE, Fader M, Coats ER, et al · · 2024 · cited 40× · PMID 38605166 · DOI 10.1038/s41591-024-02848-4 -
Functional precision medicine: the future of cancer care.
Acanda de la Rocha AM, Berlow NE, Azzam DJ. · · 2025 · cited 5× · PMID 39567286 · DOI 10.1016/j.molmed.2024.10.015 -
Sarcomas in Adolescents and Young Adults.
Greenmyer JR, Allen-Rhoades W. · · 2026 · PMID 42159886 · DOI 10.1007/s11912-026-01781-8 -
The functional imperative in high-grade glioma.
Goh LSH, Thng DKH, Ang YLE, Ho D, et al · · 2026 · PMID 41501375 · DOI 10.1038/s12276-025-01614-x -
Informing development of brain cancer therapies within "preclinical trials" using ex vivo patient tumors.
Adefolaju A, Kram DE, Mann B, Hingtgen S, et al · · 2026 · PMID 41270976 · DOI 10.1016/j.addr.2025.115736 -
Functional Precision Medicine Enhances Clinical Outcomes of Relapsed/Refractory Pediatric and Adolescent Cancer Patients
Azzam D, Rocha AAdl, Berlow N, Fader M, et al · · 2023 · DOI 10.21203/rs.3.rs-3133886/v1
Verify or expand the search:
- PubMed search for NCT05857969
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Recurrent Childhood Acute Myeloid Leukemia
Currently open trials in the same condition.
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- NCT02094794 — Total Marrow and Lymphoid Irradiation and Chemotherapy Before DSCT in Treating Patients With High-Risk ALL or AML · Phase 2 · active not recruiting
Other Florida International University trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05857969 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Florida International University
- Last refreshed: 11 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05857969.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing