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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT00038805
Eligibility Criteria:
Inclusion Criteria:
* Patients 12-75 years of age
* Patients are eligible if deemed ineligible for conventional high dose chemotherapy programs because of concurrent medical conditions. Patients with refractory AML are eligible provided ejection fraction \>= 35%; FEV1, FVC, or DLCO \>= 40%; GPT \< 3 x normal, direct bilirubin \< 2.
* Patients must have recovered from previous Grade III-IV toxicity due to prior antineoplastic therapy (except alopecia).
* Patients with AML with induction failure, relapse or 2nd remission
* Patients with MDS with IPI INT-2 or High-risk disease or CMML.
* Patients with CML in accelerated phase or blast crisis
* Patients with ALL with induction failure, relapse or 2nd remission
* Patients receiving prior BMT are eligible. If myeloablative chemoradiotherapy was used in the prior transplant patients must be \>90 days from transplant. If non-myeloablative therapy was used patients must be \>30 days post-transplant.
* Leukemia cells must express cell surface CD33 evaluated by flow cytometry in \> 20% of leukemia cells.
* Patients must have an HLA identical related donor capable of donating G-CSF stimulated peripheral blood stem cells using apheresis techniques. If patient has a contraindication to PBSC collection bone marrow can be used.
* Patients must have a Zubrod PS \<2, Cr \<2.0, direct bilirubin \<2, and transaminases SGPT \<3x normal
* Patients must have an estimated life expectancy \> 3 months
* Patient and donor must sign informed consent
Exclusion Criteria:
* no uncontrolled active infection
* no HIV disease
* no pregnancy and no nursing
* no active, uncontrolled CNS leukemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT00038805
Study Brief:
Protocol Section:
NCT00038805