A Phase 1 interventional study of Functional Precision Medicine in Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia and Recurrent Childhood Large Cell Lymphoma, sponsored by Florida International University. Recruiting at 1 site in United States. Open to participants aged 1 Day to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Florida International University · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 1,544 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in United States — 170 open to participants now, 276 under way, 13 of them phase 3. Precursor Cell Lymphoblastic Leukemia-Lymphoma · United States.
Among the 1,544 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in United States, this one is the 332nd largest by planned enrollment of the 1,269 interventional ones that give a count, is one of 43 that started in 2023, is one of 500 in phase 1, reaches primary completion later than 184 of the 274 other live ones, and was the 1,422nd registered.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →170 of the 1,544 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in United States are open now. Recruiting first, the newest first:
Wake Forest University Health Sciences · Sites in United States
Ages 18+
St. Jude Children's Research Hospital · Sites in United States
Ages 8–18 · Healthy volunteers
National Cancer Institute (NCI) · Sites in United States
Ages 1–25
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 370 Precursor Cell Lymphoblastic Leukemia-Lymphoma studies recruiting now, 96 (26%) set no upper age limit and 257 (69%) stop at 75 or younger; 247 take children under 18; 29 take healthy volunteers.
This study: 1 Day to 21 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,544 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 653 · Phase 2 593 · Phase 3 107 · Phase 4 10
First in 1984; this study’s year is marked. 43 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 65 is above the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Median enrollment 35 across the 1,269 interventional studies, 110 across the 153 observational. Of the 1,180 that completed or were terminated, 437 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
213 of 1,544 have an industry lead sponsor. The 10 most frequent:
Florida International University is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Florida International University has 2 studies filed under Precursor Cell Lymphoblastic Leukemia-Lymphoma — fewer than ten, so there is no comparison to draw.
95 of the studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03020030Phase 3Dana-Farber Cancer InstituteTreatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents | 2026-11-30 |
| NCT03844048Phase 3AbbVieAn Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial | 2027-08 |
| NCT04851717Phase 3Acacia Pharma LtdInvestigation of Remimazolam in Children Undergoing Sedation for Medical Procedures | 2027-10 |
| NCT03104491Leland MethenyInotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia | 2026-11 |
| NCT06795126Nationwide Children's HospitalLittle NIRVANA for Pediatric Pain and Anxiety | 2026-11-30 |
Add all 95 to your calendar (.ics) → With an account.
Among the 1,544 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of providing pediatric cancer patients with access to personalized treatment options and clinical management recommendations based on Functional Precision Medicine (FPM), the combination of ex vivo drug sensitivity testing (DST) and genomic profiling.
SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes (response and disease-free survival) in patients with pediatric cancers treated with FPM-guided therapy as compared to non-FPM guided (conventional) therapy.
EXPLORATORY OBJECTIVE: To explore associations between tumor molecular characteristics (genomic and transcriptomic variation) and ex vivo drug response with respect to patient ethnicity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects with suspected or confirmed diagnosis of recurrent or cancer Subjects who are scheduled for or have recently had 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 Subjects aged 7 to 17 willing to sign assent
Exclusion Criteria:
Patients with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Functional Precision Medicine
Ex Vivo Drug Sensitivity Testing + Genomic Tumor Profiling
Percentage of Patients that receive Functional Precision Medicine (FPM)-guided treatment options
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).
Time frame: Up to 6 years
Assessing Progression-Free Survival (PFS) in FPM-guided therapy versus standard of care
We will assess changes in cohort PFS by comparing PFS in patients treated with FPM-guided therapy versus PFS in patients treated with non-FPM guided conventional therapy (standard of care)
Time frame: Up to 6 years
Assessing Previous vs Trial PFS Ratio (PFS2/PFS1) in FPM-guided patients versus standard of care
We will assess changes in PFS from each patient's previous treatment versus their PFS from the treatment assigned during the trial. Assessments will be made both in the FPM-guided cohort and the non-FPM-guided cohort (standard of care). Analysis will include both the raw ratio as well as the number of incidences of 30% improved PFS on trial versus previous regimen (PFS2/PFS1 \> 1.3x).
Time frame: Up to 6 years
Assessing Overall Survival (OS) in FPM-guided patients versus standard of care patients
We will assess changes in cohort OS by comparing OS in patients treated with FPM-guided therapy versus OS in patients treated with non-FPM guided conventional therapy (standard of care)
Time frame: Up to 6 years
Started Feb 2023 (actual). Primary completion is estimated for Feb 2028, 60 months after the start.
Of 159 non-industry phase 1 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 92. This study's planned 60 months is close to that.
Counting every sponsor, half of 209 studies reached it within 57 months; a quarter within 35 and three quarters within 92.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Florida International University →