Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies

Sponsor: Children's Hospital of Philadelphia

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02323867

Patient View

This pilot study evaluates α/β T and CD19+ B cell-depleted peripheral stem cell transplantation for hematologic malignancies using alternative donors. Eligible patients include those with specific leukemias/lymphomas in remission and acceptable organ status. The intervention involves the CliniMACS system for T cell depletion. Participants must have no active infections and provide informed consent.

Patient Parameters

Program Overview

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.

Eligibility 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
  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.

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