A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias

Conditions: Acute Lymphoblastic Leukemia
MedDRA version: 18.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2015-001174-18-Outside-EU/EEA

Lead Sponsor: Genzyme Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 15

Inclusion Criteria

•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)

Are the trial subjects under 18? yes
Number of subjects for this age range: 44
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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