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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07223021
Phase
PHASE3
Status
Recruiting
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Conditions

  • B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Fludarabine 30 mg/m2/dose x 4 doses on days -6 to -3 (or -7 to -4)
  • Cyclophosphamide — DRUG
    All patients will receive Cyclophosphamide 500 mg/m2 IV on days -6 and -5 (or -7 and -6).
  • Fludarabine — DRUG
    Targeted fludarabine LD: Fludarabine 40 mg/m2/dose x 2 doses on days -6 and -5 (or -7 and -6), with doses on days -4 and -3 (or -5 and -4, if starting lymphodepletion on day -7) adjusted based on PK analysis to target a cumulative area under the curve (AUC) of 18 mg\*h/L (range 17.5-18.5mg\*h/L)
  • CAR-T — BIOLOGICAL
    will be infused based on institutional guidelines.

Study Details

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.

Key Dates

Start date
Oct 20, 2025
Status verified
Jun 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Fludarabine regimen followed by CAR-T
    Fludarabine 30 mg/m2/dose x 4 doses on days -6 to -3 (or -7 to -4)
  • Experimental: Targeted fludarabine regimen followed by CAR-T
    Fludarabine 40 mg/m2/dose x 2 doses on days -6 and -5 (or -7 and -6), with doses on days -4 and -3 (or -5 and -4, if starting lymphodepletion on day -7) adjusted based on PK analysis to target a cumulative area under the curve (AUC) of 18 mg\*h/L (range 17.5-18.5mg\*h/L

Primary Outcome Measure

compare the event free survival (EFS ) [ Time Frame: 28 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Kevin Curran, MD
1-833-MSK-KIDS
Jaap Jan Boelens, MD,PhD
1-833-MSK-KIDS
Kevin Curran, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical Center (Data Collection Only)CincinnatiOhio45229
Christine Phillips, MD
513-636-4266
Children's Hospital of Philadelphia (Data Collection Only)PhiladelphiaPennsylvania19104
Regina Myers, MD
267-426-0762

Find similar trials in New York, NY

By research site
Memorial Sloan Kettering Cancer Center· New York, NYCincinnati Children's Hospital Medical Center (Data Collection Only)· Cincinnati, OHChildren's Hospital of Philadelphia (Data Collection Only)· Philadelphia, PA

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