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A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia

StatusRecruiting
PhasePhase 3
Started2025-10-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 50% 130 → 65 participants
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-09-18
notable
Enrollment increased: 65 → 130 participants
2026-08-13
critical
Study Status, Study Design v11
Enrollment reduced: 130 → 65 participants
2026-06-11
minor
Study Status, Contacts/Locations v10
Study sites3→5
2026-06-03
minor
Study Status v9
Re-verified, no change to tracked fields
2026-05-20
minor
Study Status, Eligibility v8
Eligibility criteria-1 characters
[...] FR (mL/min/1.73 m²) = (36.2 × Height in cm) / Creatinine in μmolmg/LdL Cardiac: LVEF ≥ 50% by multi-gated acquisition scan (MUGA), [...]
Show 7 earlier versions
2026-03-27
minor
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 3 sites
2026-03-23
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 3 sites
2026-03-20
minor
Study Status v5
Re-verified, no change to tracked fields
2026-02-13
minor
Study Status, Contacts/Locations v4
Study sites1→3
2026-01-07
minor
Study Status v3
Re-verified, no change to tracked fields
2025-11-12
minor
Study Status, Contacts/Locations v2
Study sites7→1
2025-10-31
minor
Study Status, Study Description v1
Re-verified, no change to tracked fields
2025-10-28
minor
Original filing
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.
Trial Details
NCT Number NCT07223021
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Princess Maxima Center for Pediatric Oncology
Conditions B-cell Acute Lymphoblastic Leukemia
Enrollment 130 participants
Start Date 2025-10-20
Primary Completion 2028-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-17