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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT00301860
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following hematopoietic malignancies:
* Acute lymphoblastic leukemia or myeloid leukemia with \< 30% blasts in the bone marrow
* Juvenile myelomonocytic leukemia
* Chronic myelogenous leukemia in chronic or accelerated phase
* Relapsed non-Hodgkin's or Hodgkin's lymphoma in at least partial remission
* Considered at high risk (\> 30%) of toxic death with standard hematopoietic stem cell transplantation (HSCT), as indicated by at least one of the following:
* Creatinine \> 1.5 times normal OR creatinine clearance \< 70 mL/min OR tubular damage that is not corrected by cessation of chemotherapy
* DLCO \< 60% of predicted OR history of prior intubation due to lung disease (intubation for surgery excluded)
* Shortening fraction \< 30%
* History of disseminated fungal infection during chemotherapy OR currently receiving antifungal agents OR history of ≥ 2 septic episodes (confirmed by cultures) that required ICU support
* Patients with improving fungal or other infections eligible
* Improving infection is defined as confirmed negative cultures on 2 separate occasions, at least 1 week apart, and/or stable or improving imaging studies (e.g., CT scan) of the infected site
* Two imaging studies taken at least 2 weeks apart must show stable or improved disease
* History of stroke or abnormal MRI/MRA OR leukoencephalopathy OR seizures that are not fully controlled with anticonvulsants (\> 2 episodes of seizures in the preceding year or 1 episode of status epilepticus in a patient who is receiving anticonvulsant therapy)
* History of prior significant bleeding (e.g., pulmonary, CNS, or gastrointestinal) OR history of a clotting disorder as manifested by prior significant thromboses (e.g., superior vena cava, inferior vena cava, or femoral vein)
* Failed conventional therapies and not eligible for myeloablative protocols
* May have failed prior conventional HSCT
* No active CNS leukemia
* Unrelated or related donor available, meeting the following criteria:
* Matched for at least 7/8 loci by high-resolution typing
* One mismatch at A, B, or C loci allowed
* Fully matched at DRB1 locus
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* No active/progressing viral, bacterial, protozoal, or fungal infection
* Transaminases ≤ 5 times normal (except in the presence of autoimmune liver disease)
* Shortening fraction ≥ 25%
* DLCO ≥ 40% OR pulse oximetry ≥ 85% on room air
* Glomerular filtration rate ≥ 40 mL/min
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior prolonged intensive chemotherapy (\> 3 years of therapy or ≥ 3 different chemotherapeutic protocols) allowed
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00301860
Study Brief:
Protocol Section:
NCT00301860