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

Primary Purpose

Hematologic Malignancies

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CliniMACs
Sponsored by
Julie-An M. Talano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancies

Eligibility Criteria

undefined - 23 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Experimental Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assess the probability of one year leukemia free survival (LFS).
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.
Estimate the incidence and extent of acute and chronic graft vs. host disease.
Acute GVHD will be graded using the standard Glucksberg grading system.
Assess the incidence treatment-related mortality (TRM).
TRM is defined as death from non-disease related causes in the 100 days from stem cell infusion.

Full Information

First Posted
October 28, 2015
Last Updated
July 5, 2023
Sponsor
Julie-An M. Talano
Collaborators
Miltenyi Biotec, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02600208
Brief Title
Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device
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 Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julie-An M. Talano
Collaborators
Miltenyi Biotec, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Experimental Arm
Arm Type
Experimental
Arm Description
Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device
Intervention Type
Biological
Intervention Name(s)
CliniMACs
Other Intervention Name(s)
Alpha/Beta T-Cell Depletion
Intervention Description
Depletion of Alpha Beta T cells in the PBSC graft
Primary Outcome Measure Information:
Title
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.
Description
Engraftment will be defined using the standard CIBMTR definition of ANC >500 for the first of 3 consecutive days.
Time Frame
DAY 42
Secondary Outcome Measure Information:
Title
Assess the probability of one year leukemia free survival (LFS).
Description
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.
Time Frame
1 year
Title
Estimate the incidence and extent of acute and chronic graft vs. host disease.
Description
Acute GVHD will be graded using the standard Glucksberg grading system.
Time Frame
1 year
Title
Assess the incidence treatment-related mortality (TRM).
Description
TRM is defined as death from non-disease related causes in the 100 days from stem cell infusion.
Time Frame
1 year

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient: Age. Patient age < 23 years. Both genders and all races eligible. 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 Patients who do not meet disease, organ or infectious criteria. No suitable donor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie-An Talano, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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

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