MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing

June 9, 2023 updated by: Amy Moskop, Medical College of Wisconsin

Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641

This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Wisconsin
        • Contact:
        • Principal Investigator:
          • Amy Moskop

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient age < 25 years. Both genders and all races eligible.

  2. Disease eligibility

    • Acute myeloid leukemia, primary or secondary - Disease status: MRD negative (flow MRD ≤ 0.1%)
    • Myelodysplasia
    • Acute lymphoblastic leukemia - Disease status: MRD negative
    • Chronic myelogenous leukemia - Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase
    • Mixed lineage or biphenotypic acute leukemia- Disease status: MRD negative
    • Lymphoblastic lymphoma - Disease status: in remission
    • Burkitt's lymphoma/leukemia - Disease status: in remission
    • Lymphoma after relapse - Disease status: in remission
    • Other malignant hematologic diseases in remission (to be approved by PI)
  3. Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1)
  4. Evaluation of organ status as per MCW BMT SOP
  5. Infectious disease criteria: No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.
  6. Signed consent by parent/guardian or able to give consent if ≥18 years.
  7. Negative pregnancy test for patients capable of childbearing potential
  8. Sexually active patients capable of child-bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment. Sexually active men must agree to use barrier contraceptive for the duration of treatment.

Donor Eligibility:

  1. Unrelated donor meets National Marrow Donor Program criteria for donation
  2. Infectious disease testing
  3. MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases.
  4. Only Peripheral blood stem cells will be used for stem cell source on this study therefore donor must be willing to undergo G-CSF mobilization and stem cell apheresis. Donor matching. High resolution typing at all loci to be performed.

  5. Unrelated Donor:

    a. HLA typing of at least 10 alleles is required. Donor must be matched at 9/10 or 10/10 alleles (HLA A, B, C, DRB1, DQB1).Donor and collection center willing to undergo mobilization and apheresis

  6. Haploidentical Related Donor:

    1. Haploidentical parent or other related donor: Minimum match level full haploidentical (at least 5/10; HLA A, B, C, DRB1, DQB1 alleles), but use of haploidentical donors with extra matches (e.g. 6, 7, or 8/10) encouraged.

Exclusion Criteria:

  1. Patients who do not meet disease, organ, or infectious criteria.
  2. No suitable donor
  3. Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants
  4. Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease other than is specified in the protocol. Maintenance or other post-HCT therapy can be considered after discussion with the study PI.
  5. Participating in a concomitant Phase 1 or 2 study involving treatment of disease
  6. Active malignancy other than eligible disease specified in the protocol. Patients with prior malignancy can be eligible as long as at least 1 year post treatment for that malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alpha/Beta T cell depletion (TCD) plus CD19+ depletion
Alpha beta T cell and B cell depleted allogeneic transplantation with individualized dosing of ATG for patients with hematologic malignancies
Device: Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)
Participants in this study will receive a blood stem cell transplant, which will use an investigational device called the CliniMACs device to remove alpha/beta T cells and B cells from the blood cells collected from the donor. This is called T cell depletion and B cell depletion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate incidence and extent of aGVHD and engraftment in patients receiving alpha/beta T cell depleted and CD19+ B cell depleted stem cell transplant with individualized ALC-based dosing of ATG
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate incidence of chronic GVHD
Time Frame: 5 years
5 years
Evaluate time to platelet engraftment
Time Frame: 1 years
1 years
Assess incidence of viral infections
Time Frame: 2 years
2 years
Evaluate incidence of relapse/progressive disease
Time Frame: 2 years
2 years
Evaluate incidence of treatment-related mortality (TRM).
Time Frame: 2 years
2 years
Evaluate overall and relapse free survival (RFS) at 1 year
Time Frame: 1 years
1 years

Other Outcome Measures

Outcome Measure
Time Frame
Assess tempo of CD4+ T cell reconstitution.
Time Frame: 2 years
2 years
Assess tempo of immune reconstitution.
Time Frame: 2 years
2 years
Assess ATG exposure using pre- and post- HCT AUC estimates using ATG dosing module
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2032

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-MOSKOP-MABD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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