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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT00005802
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Relapsed acute myeloid leukemia or acute lymphoid leukemia after allogeneic peripheral blood stem cell transplantation (PBSCT), documented by 1 of the following:
* Morphologic relapse defined as 1 or more of the following:
* Peripheral blasts in absence of growth factor therapy
* Bone marrow blasts greater than 5% of nucleated cells
* Extramedullary (CNS, testicular, or other sites)
* Flow cytometric relapse defined as appearance in peripheral blood or bone marrow of cells with abnormal immunophenotype consistent with leukemia recurrence and noted at pretransplant
* Cytogenetic relapse defined as:
* Appearance in 1 or more metaphases from bone marrow or peripheral blood cells of nonconstitutional cytogenetic abnormality noted in at least 1 cytogenetic study performed prior to transplant OR
* New abnormality known to be associated with leukemia
* Allogeneic PBSCT from related (HLA identical and 1 antigen mismatch) OR unrelated (match) donor
* Must have achieved complete remission after PBSCT
* Current donor must be same as prior donor
* Age 10 and over
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* SWOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No congestive heart failure requiring diuretics
* No uncontrolled arrhythmia
Pulmonary:
* No pulmonary dysfunction requiring oxygen therapy
* No pneumonia or severe obstruction
* FEV\_1 at least 50% of predicted OR no greater than 50% decline from baseline
* No severe restrictive lung disease (total lung capacity less than 60% or 50% declined from baseline) not due to leukemia
Other:
* No sepsis, aspergillosis, or other active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No concurrent cyclosporine or tacrolimus during induction chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00005802
Study Brief:
Protocol Section:
NCT00005802