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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01116232
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of a hematological malignancy, including:
* Non-Hodgkin lymphoma
* Hodgkin lymphoma
* Acute myeloid leukemia or acute lymphoblastic leukemia
* Myelodysplastic syndrome (treated or untreated)
* Chronic myelogenous leukemia
* Multiple myeloma
* Chronic lymphocytic leukemia
* Myelofibrosis and other myeloproliferative disorders
* No suitable related HLA-matched or unrelated HLA-matched (8/8 or 7/8 matched) donor
* Available suitable haploidentical or partial-matched unrelated donor (high-resolution molecular HLA typing is mandatory for HLA Class I and II)
* No more than 4/8 HLA allele or antigen mismatch for a haploidentical-related first-degree family member donor
* Only 6/8 or 5/8 allele or antigen match for an unrelated donor
* Scheduled to undergo peripheral blood stem cell transplantation
* Not receiving bone marrow or ex vivo engineered or processed graft (e.g., CD34+ enrichment, T-cell depletion)
* No documented uncontrolled CNS disease
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 70-100%
* ECOG PS 0-2
* Serum bilirubin \< 3 times upper limit of normal (ULN)
* ALT and AST \< 3 times ULN
* Creatinine clearance \> 60 mL/min
* Ejection fraction \> 50%
* Forced vital capacity, FEV\_1, or DLCO \> 50% predicted
* Negative pregnancy test
* Able to cooperate with oral medication intake
* Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the past 6 months) are eligible provided they are cleared with a stress echo or nuclear myocardial perfusions stress test and a cardiology consult
* No ascites
* No HIV positivity
* No active hepatitis B or C virus infection
* No known contraindication to the administration of sirolimus, tacrolimus, anti-thymocyte globulin, or rituximab
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Not on home oxygen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT01116232
Study Brief:
Protocol Section:
NCT01116232