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 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
NCT ID:
NCT00004132
Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of Non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma Eligible for total body irradiation plus high dose chemotherapy followed by autologous peripheral blood stem cell transplantation At least 1,500,000 CD34+ cells/kg cryopreserved No prior treatment on this study
PATIENT CHARACTERISTICS: Age: 12 to 65 Performance status: Karnofsky 70-100% SWOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1000/mm3 Platelet count greater than 100,000/mm3 If conditioning regimen scheduled soon after apheresis, platelet count of greater than 50,000/mm3 but less than 100,000/mm3 allowed Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No congestive heart failure No New York Heart Association class III or IV heart disease Pulmonary: DLCO at least 50% predicted Other: No prior or concurrent second malignancy No active infection or oral mucositis No insulin dependent diabetes mellitus HIV negative No sensitivity to E. coli derived products Not pregnant or nursing Fertile patients must use effective contraception one month before, during, and one month after study
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow or peripheral blood stem cell transplantation, unless undergoing second transplant of a tandem transplant regimen, with no complications after first transplant No concurrent interleukin-11 Chemotherapy: No other concurrent cytotoxic chemotherapy, except intrathecal methotrexate for CNS involvement Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy that would preclude total body irradiation Surgery: Not specified Other: At least 30 days since prior investigational devices or drugs, except Baxter Isolex i column No other concurrent investigational agents No concurrent prophylactic oral cryotherapy during chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT00004132
Study Brief:
Protocol Section:
NCT00004132