Study on Stem Cell Transplantation for Blood Cancers Using a New Cell Depletion Method

Sponsor: Julie-An M. Talano

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02600208

Provider View

This clinical trial is testing a new method of preparing stem cells for transplantation in patients with blood cancers. The study aims to see if this method can improve transplant success and reduce complications like graft-versus-host disease (GVHD).

Patient Parameters

Program Overview

This study is exploring a new way to prepare stem cells for transplantation in patients with blood cancers. The method involves using a device called CliniMACS to remove specific types of immune cells (alpha/beta T cells and CD19+ B cells) from the donor stem cells. The goal is to see if this approach can help the transplanted cells grow successfully in the patient's body and reduce the risk of complications like graft-versus-host disease (GVHD). The study will also look at how well patients do one year after the transplant, focusing on their survival without leukemia.

Description

The purpose of this study is to test a new method for preparing stem cells for transplantation in patients with blood cancers. The method uses a device called CliniMACS to remove certain immune cells (alpha/beta T cells and CD19+ B cells) from the donor stem cells. This process is called T cell and B cell depletion. The study will evaluate if this method can help the transplanted cells grow successfully in the patient's body and reduce the risk of severe graft-versus-host disease (GVHD), a condition where the donor cells attack the patient's body. The study will also assess how well patients do one year after the transplant, focusing on their survival without leukemia.

Eligibility Criteria

Inclusion Criteria

  • Patients under 23 years old.
  • Diagnosed with certain blood cancers, including:
    • Acute myeloid leukemia (AML) in remission or with less than 10% bone marrow blasts.
    • Myelodysplasia.
    • Acute lymphoblastic leukemia (ALL) in hematologic remission.
    • Chronic myelogenous leukemia (CML) in chronic phase, accelerated phase, or blast crisis now in second chronic phase.
    • Mixed lineage or biphenotypic acute leukemia.
    • Lymphoblastic lymphoma in remission.
    • Burkitt's lymphoma/leukemia in remission.

Exclusion Criteria

  • Patients who do not meet the disease, organ, or infection criteria.
  • Patients without a suitable donor.

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