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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01020734
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
* Achieved complete response (CR1) after induction chemotherapy
* Recurrent AML that went into second CR (CR2) after salvage chemotherapy, except those who have undergone prior allogeneic HSCT
* No acute promyelocytic leukemia or acute myeloid leukemia with chromosomal changes t(8;21), inv 16, or t(15;17)
* Must have a donor available meeting one of the following criteria:
* HLA-matched sibling of 65 years or younger
* 6/6 HLA-matched unrelated donor (younger than 55 years) for antigen A, B, and DR
* HLA-mismatched family member (offspring, parents, haploidentical sibling)
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Bilirubin \< 2.0 mg/dL
* AST \< 3 times the upper limit of normal
* Creatinine \< 2.0 mg/dL
* Ejection fraction \> 40% on MUGA scan
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
75 Years
Study:
NCT01020734
Study Brief:
Protocol Section:
NCT01020734