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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT00502905
Eligibility Criteria:
Inclusion Criteria:
1. Acute leukemia past first remission, in first or subsequent relapse, in first remission (high-risk, i.e., cytogenetics other than t(8;21, inv 16, t(15;17)) or induction failures.
2. Myelodysplastic syndromes in any clinical stage, excluding only patients who have isolated stable mono-cytopenia and who are clinically stable.
3. Patient has not been administered any other systemic chemotherapeutic drug (including Mylotarg) within 21 days prior to trial enrollment (BMT Day -7 or BMT day -9). (Hydroxyurea and intrathecal chemotherapy is permitted).
4. No uncontrolled infection.
5. Patients up to age 65 will be eligible for this study.
6. ALLOGENEIC TRANSPLANTATION:
Patients should have an acceptable related or unrelated volunteer donor available for a bone marrow peripheral blood progenitor cell or cord blood transplant. Bone marrow and peripheral blood cell donors should be matched for at least 5 of 6 HLA A, B and DR loci. Cord blood donors should be matched for at least 4 of 6 A, B and DR loci.
7. Life expectancy is not severely limited.
8. Pulmonary, cardio, renal and liver function tests normal.
9. In patients \< 7 years pulmonary function will be assessed per pediatric BMT routine.
10. No evidence of chronic active hepatitis or cirrhosis.
11. HIV-negative.
12. Female patient is not pregnant
13. Signed informed consent.
14. Patient admitted on Sunday, or Monday to allow for pharmacokinetic directed therapy.
Exclusion Criteria:
1\) Not fulfilling eligibility criteria above.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
66 Years
Study:
NCT00502905
Study Brief:
Protocol Section:
NCT00502905