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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT07223021
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- 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 hyperbilirubinemia
- Hepatic: AST and ALT \< 5x the upper limit of normal for age, unless thought to be leukemic disease-related
You likely can't join if
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or...
- Patients with tisagenlecleucel that is deemed out of specification (OOS) will be excluded from this protocol
- Clinically significant active and uncontrolled infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures...
- Patient/parent/guardian unable to give informed consent or unable to comply with the treatment protocol.
- Pregnant or lactating women
See the full eligibility 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 hyperbilirubinemia
- Hepatic: AST and ALT \< 5x the upper limit of normal for age, unless thought to be leukemic disease-related
- Renal: Calculated glomerular filtration rate (GFR) ≥ 70 ml/min/1.73m\^2. (based on Schwartz formula GFR (mL/min/1.73 m²) = (36.2 × Height in cm) / Creatinine in mg/dL
- Cardiac: LVEF ≥ 50% by multi-gated acquisition scan (MUGA), resting echocardiogram, or cardiac magnetic resonance imaging (MRI) within 6 weeks of screening
- Pulmonary: Oxygen saturation as recorded by pulse oximetry of ≥ 90% on room air
- Adequate performance status:
- Age ≥ 16 years: ECOG ≤ 1 or Karnofsky \> 60% at treatment
- Age \< 16 years: Lansky ≥ 60% at treatment
- Willing to participate as research subject and provide written informed consent from parents/legal representative, patient, and age-appropriate assent as appropriate before any study specific screening procedures are...
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including...
- Patients with tisagenlecleucel that is deemed out of specification (OOS) will be excluded from this protocol
- Clinically significant active and uncontrolled infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA etc.)
- Patient/parent/guardian unable to give informed consent or unable to comply with the treatment protocol.
- Pregnant or lactating women
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Cincinnati, Ohio, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.