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UNRELATED AND PARTIALLY MATCHED RELATED DONOR PERIPHERAL STEM CELL TRANSPLANTATION WITH Alpha/Beta T CELL AND B CELL DEPLETION FOR PATIENTS WITH HEMATOLOGIC MALIGNANCIES


Description

This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with hematologic malignancies receiving alternative donor (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and graft versus host disease (GVHD), and one year leukemia free survival.

Trial Eligibility

Inclusion Criteria: 1. Leukemias/lymphomas * Acute myeloid leukemia, primary or secondary Disease status: remission or \<10% bone marrow blasts * Myelodysplasia * Acute lymphoblastic leukemia Disease status: in hematologic remission * Chronic myelogenous leukemia Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase. * Mixed lineage or biphenotypic acute leukemia * Lymphoblastic lymphoma Disease status: remission * Burkitt's lymphoma/leukemia: Disease status- in remission 2. Acceptable organ status clearance 3. No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic 4. Signed informed consent. 5. Negative pregnancy test for females of childbearing potential. Exclusion Criteria: 1. Patients who do not meet disease, organ or infectious criteria. 2. No suitable donor 3. Received previous allogeneic transplant Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.

Study Info

Organization

Children's Hospital of Philadelphia


Primary Outcome

Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days


Outcome Timeframe 1 year

NCTID NCT02323867

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2014-10

Completion Date 2025-10

Enrollment Target 140

Interventions

DEVICE Alpha Beta T cell depletion

Locations Recruiting

The Children's Hospital of Philadelphia

United States, Pennsylvania, Philadelphia


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