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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01927120
Eligibility Criteria:
Inclusion Criteria:
* Patients must have an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft.
* Acute myeloid leukemia, myelodysplasia, acute lymphoblastic leukemia, chronic myeloid leukemia, or myeloproliferative neoplasms requiring a matched allogeneic HSCT.
* Acute Leukemia (AML or ALL) must be in complete remission defined as: \<5% marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow \>20% cellular, and peripheral absolute neutrophil count \>1000/µL (platelet recovery is not required).
* Myelodysplasia (MDS) and chronic myeloid leukemia (CML): Must have \<5% marrow blasts.
* Myeloproliferative neoplasms (MPN): Must have \<5% peripheral / marrow blasts.
* Adequate vital organ function:
1. Left ventricular ejection fraction (LVEF) ≥ 45% by multi gated acquisition (MUGA) scan or ECHO
2. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC), and adjusted diffusing lung capacity oxygenation (DLCO) ≥ 50% of predicted values on pulmonary function tests
3. Transaminases (AST, ALT) \< 2 times upper limit of normal values
4. Creatinine clearance ≥ 50 cc/min.
* Performance status: Karnofsky Performance Status Score ≥ 80%
* Donor eligibility: Eligible donors will include healthy sibling, relative or unrelated donors that are matched with the patient at HLA-A, B, C, and DRB1 by high resolution typing.
Exclusion Criteria:
* Active infection not controlled with appropriate antimicrobial therapy
* History of HIV, hepatitis B, or hepatitis C infection
* Anti-thymocyte globulin, alemtuzumab, bortezomib, or cyclophosphamide administered within 14 days before or planned to receive with HCT conditioning or as part of GVHD prophylaxis in the 14 days after HCT.
* Hypersensitivity to recombinant human IL-2
* Chronic lymphocytic leukemia, Hodgkin lymphoma, and non-hodgkin lymphoma are excluded as these malignancies may express the IL-2 receptor and pose a potential growth signal to any present disease.
* Sorror's co-morbidity factors with total score \>4
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01927120
Study Brief:
Protocol Section:
NCT01927120