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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 (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02600208
Collaborator
Miltenyi Biotec, Inc. (Industry)
60
Enrollment
1
Location
1
Arm
134
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CliniMACs
 Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
BT13BTθ51 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha Beta T Cell and B Cell Depletion For Patients With Hematologic Malignancies
Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Experimental Arm

Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device

Biological: CliniMACs
Depletion of Alpha Beta T cells in the PBSC graft
Other Names:
  • Alpha/Beta T-Cell Depletion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the engraftment of patients receiving unrelated donor or partially matched related donor peripheral stem cells that have T cell depleted and CD19+ B cell depleted using the CliniMACS device. [DAY 42]

      Engraftment will be defined using the standard CIBMTR definition of ANC >500 for the first of 3 consecutive days.

    Secondary Outcome Measures

    1. Assess the probability of one year leukemia free survival (LFS). [1 year]

      Leukemia relapse is defined as presence of malignant cells in the blood or other body site after initiation of conditioning in a patient previously in remission.

    2. Estimate the incidence and extent of acute and chronic graft vs. host disease. [1 year]

      Acute GVHD will be graded using the standard Glucksberg grading system.

    3. Assess the incidence treatment-related mortality (TRM). [1 year]

      TRM is defined as death from non-disease related causes in the 100 days from stem cell infusion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 23 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Julie-An M. Talano
    • Miltenyi Biotec, Inc.

    Investigators

    • Principal Investigator: Julie-An Talano, MD, Medical College of Wisconsin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Julie-An M. Talano, Associate Professor - Department of Pediatrics - Division of Hematology/Oncology, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT02600208
    Other Study ID Numbers:
    • BT13BTθ51
    First Posted:
    Nov 9, 2015
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:
    Neoplasms
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Apr 6, 2022