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 @ 4:45 AM
Ignite Modification Date:
2025-12-25 @ 4:45 AM
NCT ID:
NCT00002718
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Acute myelogenous leukemia (AML) meeting 1 of the following conditions:
* Failed to achieve first remission after an intensive induction regimen containing an anthracycline and cytarabine
* In second remission and not enrolled in a protocol for autologous bone marrow transplantation
* Failed to achieve or sustain second remission
* In first remission but at high risk of relapse because of 1 of the following factors:
* High-risk cytogenetic features (monosomy 7,5q-, trisomy 8, or t(9;22))
* AML secondary to treatment of a prior malignancy and without good-risk cytogenetic features of t(8;21), t(15;17), or inv 16
* AML secondary to myelodysplastic disease
* Acute lymphocytic leukemia (ALL) meeting 1 of the following conditions:
* In second remission with initial relapse occurring within 2 years of diagnosis
* In first complete remission with high-risk cytogenetics (t(9;22) or t(4;11))
* In third or subsequent remission
* Failed to achieve or sustain a second remission
* Chronic myelogenous leukemia (CML) in first or second chronic phase or accelerated phase
* Stage IV lymphoblastic lymphoma not in first remission or that failed to achieve a remission within the first 4 weeks of induction therapy
* Juvenile CML
* Myelodysplastic syndrome
* Severe aplastic anemia unresponsive to anti-thymocyte globulin or cyclosporine
* No CNS or skin involvement with leukemia
* No requirement for mediastinal irradiation
* No healthy, HLA-identical related donor of at least 1 year of age or matched unrelated donor available within 4-6 months
* Availability of a healthy, 1-3 HLA-A, -B, and -DR mismatched related donor
* Willing and able to undergo general anesthesia for marrow donation and a 5-day course of filgrastim (G-CSF) with 2 daily leukaphereses
PATIENT CHARACTERISTICS:
Age:
* Under 50 (50 and over allowed on a case-by-case basis)
Performance status:
* Age 16 and over:
* Karnofsky 70-100%
* Under age 16:
* Lansky 50-100%
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 2.0 mg/dL (in the absence of liver involvement)
* AST less than twice normal (in the absence of liver involvement)
Renal:
* Creatinine normal OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* Asymptomatic or LVEF greater than 50% at rest, with improvement during exercise
Pulmonary:
* Asymptomatic or DLCO greater than 50% predicted (corrected for hemoglobin)
Other:
* No known hypersensitivity to mouse protein or chicken egg products
* No active viral, bacterial, or fungal infection
* HIV-1, HIV-2, HTLV-1, and HTLV-2 negative
* No other concurrent medical condition that would preclude transplantation
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
Surgery
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
49 Years
Study:
NCT00002718
Study Brief:
Protocol Section:
NCT00002718