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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT00800150
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histopathologically confirmed diagnosis of 1 of the following:
* Acute myeloid leukemia (AML)
* Myelodysplastic syndromes
* Intermediate- or high-risk disease
* Myelofibrosis
* Granulocytic sarcoma (chloroma)
* With or without bone marrow involvement
* Mixed lineage leukemia
* Induction therapy must have been directed predominantly against AML
* Acute lymphoblastic leukemia
* Non-Hodgkin lymphoma
* Multiple myeloma
* Relapsed or refractory disease with M3 marrow (marrow blasts \> 25%), meeting 1 of the following criteria:
* Persistent disease after an induction attempt
* Persistent initial disease after two induction attempts
* Relapse after one re-induction attempt (second relapse)
* Persistent disease after first relapse and initial re-induction attempt
* Not eligible for myeloablative allogeneic hematopoietic stem cell transplantation due to age (\> 50 years), organ insufficiency, or significant comorbidity
* Patients 16-50 years of age must meet ≥ 1 of the following criteria:
* Ejection fraction 50-60% by MUGA scan and/or echocardiogram
* DLCO 50-75% of predicted
* Creatinine clearance or GFR 60-80 mL/min
* Serum bilirubin ≤ 2.0 mg/dL
* SGOT and SGPT 1.5-5 times upper limit of normal
* No other medical and/or psychosocial problem that, in the opinion of the primary physician or principal investigator, would place the patient at unacceptable risk from study regimen
* No Fanconi anemia
* HLA-identical sibling OR matched unrelated donor available
PATIENT CHARACTERISTICS:
* Zubrod or Karnofsky performance status 70-100%
* Negative pregnancy test
* Able to lie supine in a full body cast for 30 minutes
* No HIV infection
* No evidence of active hepatitis B or C infection
* No evidence of cirrhosis
* No uncontrolled viral, bacterial, or fungal infection within the past 4 weeks
* No radiographic changes indicating pulmonary disease (e.g., pulmonary nodules, infiltrates, or pleural effusion) unless cleared by pulmonary biopsy that shows no evidence of active pulmonary disease
* No major medical or psychiatric disorder that would seriously compromise patient tolerance of study regimen
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiation therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00800150
Study Brief:
Protocol Section:
NCT00800150