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:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT00611351
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed diagnosis of 1 of the following:
* Acute myeloid leukemia
* Acute lymphocytic leukemia
* Chronic myelogenous leukemia beyond first chronic phase (i.e., 2nd chronic phase, accelerated phase, or blast crisis)
* Multiple myeloma
* Myelodysplastic syndromes
* Malignant lymphoma
* Myelofibrosis
* Requirement for myeloablative conditioning regimen confirmed by attending physician
* Available donor must meet the following criteria:
* HLA phenotypically identical unrelated donor by low, intermediate, or high resolution for HLA class I antigens, and by high resolution for HLA class II antigens
* Matched at the A, B, and DRβ1 loci
* Single HLA-A or HLA-B antigen mismatch allowed
* Meets all National Marrow Donor Program or foreign registry criteria for allogeneic bone marrow/stem cell donors
* Peripheral blood stem cells are the preferred product on this study but bone marrow is allowed
* Karnofsky performance status 70-100%
* DLCO ≥ 50% predicted
* LVEF ≥ 45%
* Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 65 mL/min
* Serum total bilirubin ≤ 2.0 mg/dL
* Fertile patients must use effective contraception
Exclusion Criteria:
* No active uncontrolled infection
* Not pregnant or nursing/negative pregnancy test
* No HIV infection
* No chronic active hepatitis B or C or evidence of cirrhosis on liver biopsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT00611351
Study Brief:
Protocol Section:
NCT00611351