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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT01749293
Eligibility Criteria:
Inclusion Criteria:
1. First-degree related donor or half-sibling who is at minimum HLA haploidentical
2. Lack of fully matched donor (related or unrelated). Patients with a matched unrelated donor may only be enrolled if they require an urgent transplant. Urgency of transplant will judged by PI and co-investigators.
3. Eligible diagnoses are listed below:
1. Low-grade non-Hodgkin's lymphoma or plasma cell neoplasm that has progressed during multiagent therapy including follicular lymphoma, Marginal zone (or MALT) lymphoma, lymphoplasmacytic lymphoma / Waldenstrom's macroglobulinemia, Hairy cell leukemia, Small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL), Prolymphocytic leukemia, Multiple myeloma and Plasma cell leukemia
2. Poor-risk SLL or CLL
3. Aggressive lymphoma that has failed at least one prior regimen of multiagent chemotherapy, and patient is either ineligible for autologous BMT or autologous BMT is not recommended including Hodgkin lymphoma, high grade Follicular lymphoma, Mantle cell lymphoma, Diffuse large B-cell lymphoma, Burkitt's lymphoma/leukemia, Anaplastic large cell lymphoma, Plasmablastic lymphoma, Peripheral T-cell lymphoma
4. Relapsed or refractory acute leukemias.
5. Poor-risk acute leukemia in first remission:
i. Acute myeloid leukemia (AML) with at least one of the following:
* AML arising from myelodysplastic syndrome (MDS) or a myeloproliferative disorder
* Presence of FLT3 internal tandem duplications
* Poor-risk cytogenetics
ii. Acute lymphoblastic leukemia and/or lymphoma (ALL) with at least one of the following:
* Poor risk cytogenetics
* Primary refractory disease
iii. Biphenotypic leukemia
f. MDS with at least one of the following poor-risk features: i. Poor-risk cytogenetics ii. Int-2 or high IPSS score iii. Treatment-related MDS iv. MDS diagnosed before age 21 years v. Progression on or lack of response to standard hypomethylator therapy vi. Life-threatening cytopenias
g. Imatinib-refractory chronic myelogenous leukemia (CML) in accelerated or chronic phase
h. Philadelphia chromosome negative myeloproliferative neoplasm
i. Chronic myelomonocytic leukemia
5\. Adequate end-organ function as measured by:
1. Left ventricular ejection fraction ≥ 35%
2. Bilirubin ≤ 3.0 mg/dL and ALT and AST \< 5 x ULN
3. FEV1 and FVC \> 40% of predicted
6\. Karnofsky score \> 60
7\. Lack of recipient anti-donor HLA antibody
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
75 Years
Study:
NCT01749293
Study Brief:
Protocol Section:
NCT01749293