Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genzyme, a Sanofi Company
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Adequate liver, renal, pancreatic, and cardiac function
Have received no prior HSCT (study amended in Phase 2 to exclude patients with prior HSCT)
You may not be if
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
