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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00004904
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy with relapse after allogeneic bone marrow transplantation (BMT) or autologous BMT if no HLA matched sibling donor is available OR Histologically proven acute myeloid leukemia (AML) without an available HLA matched sibling donor and with one of the following: Failure of induction, defined as inability to obtain remission with 2 courses of induction or failure during treatment Second or greater remission OR Histologically proven acute lymphocytic leukemia (ALL) in an adult over age 15 without an available HLA matched sibling donor and with one of the following: Philadelphia chromosome positivity by cytogenetics or PCR Relapse or second or greater remission Two or more prognostic features (over age 30, WBC on presentation over 35,000/mm3, time to complete response over 4 weeks, t(4:11), or B-cell ALL) OR Histologically proven chronic myelogenous leukemia In chronic phase without an A, B, and DR unrelated matched donor OR In accelerated phase, defined as new cytogenetic abnormalities or difficulty maintaining a normal WBC due to dose limiting cytopenias (thrombocytopenias or anemia) from hydroxyurea or interferon OR In blast transformation OR Histologically proven aplastic anemia without an available HLA matched sibling donor and failure of an immunosuppressive therapy regimen using either cyclosporine, antithymocyte globulin, or both OR Histologically proven lymphoma without an available HLA matched donor and failure of at least 2 different chemotherapy regimens OR Histologically proven cutaneous T-cell lymphoma without an available HLA matched donor and failure of interferon and PUVA (psoralen and ultraviolet A radiation) OR Histologically proven myelodysplastic syndrome without an available HLA matched sibling donor and with one of the following: 5% or greater blasts in marrow Multiple cytogenetic abnormalities History of infections from neutropenia 1, 2, or 3 antigen mismatched related donor available
PATIENT CHARACTERISTICS: Age: Physiologic age 45 and under Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No coronary artery disease requiring medical therapy Resting LVEF at least 40% Pulmonary: FEV1/FVC at least 60% predicted DLCO at least 60% predicted Other: HIV negative No prior malignancy except basal cell or squamous cell skin cancer Other malignancies for which the patient is cured by local surgical therapy, such as head and neck cancer or stage I breast cancer, are considered on an individual basis Not pregnant Negative pregnancy test Fertile patients must use effective contraception No psychiatric illness or mental deficiency that would preclude compliance or informed consent
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
45 Years
Study:
NCT00004904
Study Brief:
Protocol Section:
NCT00004904