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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT00350818
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a diagnosis of AML (WHO classification: \>=20% blasts in the bone marrow and / or peripheral blood), or MDS (IPSS intermediate-2 or higher) that at the time of allogeneic transplantation were in.
2. Induction Failure, relapsed disease or second or greater remission.
3. Patients in first complete remission that required more than 2 cycles of treatment to achieve the remission.
4. Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or
5. HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch)
6. Age 18 to 75 years and
7. Left ventricular ejection fraction \>40% and
8. FEV1, FVC and DLCO \>40% and
9. Serum creatinine \<1.6 mg/dL and
10. Serum bilirubin \< 1.6 mg/dL and
11. SGPT \< 3 X upper limit of normal and
12. All patients and donors or guardian should be able to understand and sign informed consent.
13. Women of childbearing potential (any female who has experienced menarche, and who has not undergone surgical sterilization or is not post-menopausal) must have a negative serum pregnancy test.
Exclusion Criteria:
1. HIV positive
2. AML or MDS in first complete remission (defined as: bone marrow with less than 6% blasts, no circulating blasts, and a platelet count greater than 100,000 /mm\^3.)
3. Active uncontrolled infection
4. Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00350818
Study Brief:
Protocol Section:
NCT00350818