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NCT07223021 · ClinicalTrials.gov registry record · Phase 3
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
A Phase 3 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 130
- Enrollment target
- 3
- Study locations
NCT07223021: Recruiting Phase 3 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
NCT07223021 is a Phase 3 study of B-cell Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 130 participants, above the 83-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (57% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07223021, a Phase 3 study of B-cell Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 130 participants
- Enrollment target
- 3
- Study locations
Study Summary
The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy. The researchers will compare PK-targeted fludarabine dosing with standard fludarabine dosing to see which treatment approach is more effective. The researchers will also look at whether PK-targeted fludarabine dosing is feasible (practical), the side effects of the study treatment, and how the study treatment affects people's quality of life. The researchers will measure quality of life by having participants complete questionnaires.
Primary Outcome
EFS is defined as time from randomization until non-response at day 28 after CAR T cell infusion, loss of B-cell aplasia \<6 months from the time of CAR T cell infusion, disease relapse, initiation of anti-leukemic therapy or death of any cause
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL CAR-T
Study Locations (3)
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cincinnati Children's Hospital Medical Center (Data Collection Only) - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia (Data Collection Only) - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2025-10-20 |
| Est. Completion | 2028-10 |
| Phase | Phase 3 |
What NCT07223021 shows while recruiting
NCT07223021 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 83-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (57% higher).
The record links to 1 condition, with B-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT07223021 reports a single indexed study location in New York, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07223021 about?
NCT07223021 is a clinical study titled "A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia". The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy. The researchers will compa...
What is the current status of trial NCT07223021?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 130 participants. The study started on 2025-10-20. Estimated completion is 2028-10.
What conditions does trial NCT07223021 study?
This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT07223021?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), CAR-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT07223021?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07223021 being conducted?
This trial has 3 study locations across New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07223021's enrollment target sits among peer trials
130 5th of 21 higher than 17 of 21 other B-cell Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other B-cell Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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