Philadelphia, Pennsylvania 19103


Purpose:

This is a single arm pilot study for patients using α/β T cell-depleted 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 GVHD, and one year leukemia free survival.


Criteria:

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 Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.


NCT ID:

NCT02323867


Primary Contact:

Principal Investigator
Nancy J Bunin, MD
Children's Hospital of Philadelphia

Margaret Tartaglione, RN
Phone: 215-590-4029
Email: tartaglione@email.chop.edu


Backup Contact:

Email: hankinsp@email.chop.edu
Patricia Hankins, RN
Phone: 215-590-4029


Location Contact:

Philadelphia, Pennsylvania 19103
United States

Margaret Tartaglione, RN
Phone: 215-590-4029
Email: tartaglione@email.chop.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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