A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
Recruiting
Phase 3
Interventional Study
B-cell Acute Lymphoblastic Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 130 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Other
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients with B-ALL and eligible to receive commercial tisagenlecleucel.
* Patient's weight \> 9 kg at time of lymphodepleting chemotherapy
* Adequate organ function at time of LD is required and is defined:
* Hepatic: Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyp…
Contacts
Jaap Jan Boelens, MD, PhD
1-833-MSK-KIDS
CONTACT