Status:
COMPLETED
A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
PHASE2
Brief 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) w...
Eligibility Criteria
Inclusion
- NOTE: the following eligibility criteria were applicable to acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) patients for the Phase 1 portion of this study, and to ALL patients for the Phase 2 portion of the study (only ALL patients were allowed in the Phase 2 portion of the study).
- ALL with \> 25% blasts in bone marrow; AML with ≥ 5% blasts in bone marrow; ALL and AML patients 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 and ≤ 1 hematopoietic stem cell transplant (HSCT); ALL: 1-3 prior induction regimens
- Adequate liver, renal, pancreatic, and cardiac function
- Have received no prior HSCT (study amended in Phase 2 to exclude patients with prior HSCT)
Exclusion
- NOTE: the following eligibility criteria were applicable to ALL and AML patients for the Phase 1 portion of this study, and to ALL patients for the Phase 2 portion of the study (only ALL patients were allowed in the Phase 2 portion of the study).
- Burkitt's leukemia
- Previous treatment with clofarabine
- Uncontrolled systemic fungal, bacterial or other infection and 48 hrs negative blood cultures required for patients with a history of fever within 3 days of enrollment
- Active CNS involvement (i.e., should be CNS1 or CNS2)
- Inadequate time since last therapy: ≤ 14 days since last cytotoxic chemotherapy; ≤ 7 days since last biologic therapy; ≤ 14 days since last monoclonal antibody therapy
- Have received prior HSCT (study amended in Phase 2 to exclude patients with prior HSCT)
- Pregnant or lactating
- Have tested positive for hepatitis B or hepatitis C infection or history of cirrhosis
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00315705
Start Date
March 1 2006
End Date
May 1 2010
Last Update
April 14 2014
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Alabama
Birmingham, Alabama, United States
2
Children's Hospital of Los Angeles
Los Angeles, California, United States
3
Rady Children's Hospital
San Diego, California, United States
4
Connecticut Children's Medical Center
Hartford, Connecticut, United States