Phase I/II Clinical Study of Fludarabine and Etoposide in Combination with Nelarabine in Pediatric Patients with Refractory or Relapsed Acute T-lymphoblastic leukemia.
Phase 1
- Conditions
- Refractory or Relapsed Acute T-lymphoblastic leukemia
- Registration Number
- JPRN-UMIN000006467
- Lead Sponsor
- Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
Not provided
Exclusion Criteria
1. Have central nervous system involvement. 2. Have history of receiving hematopoietic cell transplantation 3. Secondary T-ALL 4. Have other malignancy 5. Are pregnant or lactating. 6. Have psychiatric disorders that would interfere with consent, study participation, or follow-up. 7. Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or pancreas.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: To determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and the recommended Phase 2 dose (RP2D) of FLEND therapy in pediatric patients with relapsed or refractory T-ALL. Phase II: To estimate the overall response (OR) rate of FLEND therapy in pediatric patients with refractory or relapsed T-ALL.
- Secondary Outcome Measures
Name Time Method 1. Incidence rate of adverse event 2. Overall response rate 3. Complete response rate 4. Event-free survival (4-month and 1-year) 5. Overall survival (4-month and 1-year) 6. Pharmacokinetic (PK) study 7. Minimal residual disease (MRD) 8. Drug-resistant genes