Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device

Sponsor: Julie-An M. Talano

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02600208

Patient View

This pilot study evaluates α/β T cell and CD19+ B cell depletion using the CliniMACS device in patients under 23 with hematologic malignancies. It aims to reduce GVHD risk and ensure durable engraftment. Eligible diseases include various leukemias and lymphomas in remission. The intervention involves depleting specific T cells in the PBSC graft.

Patient Parameters

Program Overview

This is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival.

Description

The purpose of this research study is to evaluate a new method of T cell depletion using the Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant utilizing either a unrelated donor or partially matched/haploidentical related donor. This new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot study will evaluate if this new method of T cell and B cell depletion is a more effective way of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a durable engraftment.

Eligibility Criteria

Inclusion Criteria

Patient:

  1. Age. Patient age < 23 years. Both genders and all races eligible.
  2. Disease eligibility

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

Exclusion Criteria

  • Patient

    1. Patients who do not meet disease, organ or infectious criteria.
    2. No suitable donor

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