Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT00315705
Eligibility Criteria:
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)
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT00315705
Study Brief:
Protocol Section:
NCT00315705