At a glance
ClinicalIndex Comparison Record- ✓ALL with >25% blasts in bone marrow; AML with ≥5% blasts in bone marrow (Phase 1 only); may have extramedullary disease
- ✓Karnofsky Performance Status ≥50 for patients >10 years old; Lansky Performance Status ≥50 for patients ≤10 years old
- ✓Prior therapy: AML 1-2 prior induction regimens; ALL 1-3 prior induction regimens
- ✓Adequate liver, renal, pancreatic, and cardiac function
- ✕Burkitt's leukemia
- ✕Previous treatment with clofarabine
- ✕Uncontrolled systemic fungal, bacterial or other infection; 48 hours negative blood cultures required for patients with fever within 3 days of enrollment
- ✕Active CNS involvement (must be CNS1 or CNS2)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias.
In Brief
A Phase 2 clinical trial evaluating clofarabine, Etoposide, and 1 other intervention for Acute Lymphoblastic Leukemia and 2 related conditions. Completed, enrolled 50 participants across 13 sites.
Detailed Summary
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted. The purpose of the phase 1 portion of this study was to determine if clofarabine added to a combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the phase 2 portion of the study was to measure the effectiveness of the combination therapy in children with ALL.
Study Details
Timeline
Interventions
Clofarabine 20-40 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle as the first of the three IV interventions administered. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Etoposide 75-100 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle following clofarabine therapy. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Cyclophosphamide 340-440 mg/m²/day as 30-60 minute intravenous (IV) infusion daily for 5 days of a 28 day cycle following the other two interventions. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.