Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies (AB-CliniMACs)

December 19, 2023 updated by: Nancy Bunin, Children's Hospital of Philadelphia

UNRELATED AND PARTIALLY MATCHED RELATED DONOR PERIPHERAL STEM CELL TRANSPLANTATION WITH Alpha/Beta T CELL AND B CELL DEPLETION FOR PATIENTS WITH HEMATOLOGIC MALIGNANCIES

This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with hematologic malignancies receiving alternative donor (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and graft versus host disease (GVHD), and one year leukemia free survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

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

  • Name: Patricia Hankins, BSN, RN, CCRC
  • Phone Number: 215-590-5168
  • Email: hankinsp@chop.edu

Study Contact Backup

  • Name: Meghan Rys, MS, CCRP
  • Phone Number: 215-590-6625
  • Email: rysm@chop.edu

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Recruiting
        • The Children's Hospital of Philadelphia
        • Sub-Investigator:
          • Stephan A Grupp, MD, PhD
        • Principal Investigator:
          • Nancy J Bunin, MD
        • Contact:
          • Patricia Hankins, BSN, RN, CCRC
          • Phone Number: 215-590-5168
          • Email: hankinsp@chop.edu
        • Contact:
          • Meghan Rys, MS, CCRP
          • Phone Number: 215-590-6625
          • Email: rysm@chop.edu

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

No older than 23 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
  2. Acceptable organ status clearance
  3. No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic
  4. Signed informed consent.
  5. Negative pregnancy test for females of childbearing potential.

Exclusion Criteria:

  1. Patients who do not meet disease, organ or infectious criteria.
  2. No suitable donor
  3. Received previous allogeneic transplant

Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alpha Beta Total Body Irradiation - total body irradiation (TBI) first

Alpha Beta Total Body Irradiation - TBI first Day Treatment

  • 11 Anti-thymocyte globulin (ATG)
  • 10 ATG
  • 9 ATG
  • 8 TBI
  • 7 TBI
  • 6 TBI
  • 5 Thiotepa
  • 4 Thiotepa
  • 3 Cyclophosphamide
  • 2 Cyclophosphamide
  • 1 Rest 0 Transplant with alpha beta T cell depleted stem cells
Device: Alpha Beta T cell depletion
Experimental: Alpha Beta Total Body Irradiation - TBI last

Alpha Beta Total Body Irradiation - TBI last Day Treatment

  • 9 ATG
  • 8 ATG
  • 7 Thiotepa + ATG
  • 6 Thiotepa
  • 5 Cyclophosphamide
  • 4 Cyclophosphamide
  • 3 TBI
  • 2 TBI
  • 1 TBI 0 Transplant with alpha beta T cell depleted stem cells
Device: Alpha Beta T cell depletion
Experimental: Alpha Beta Non-irradiation regimen

Alpha Beta Non-irradiation regimen Day Treatment

  • 9 Busulfan + ATG
  • 8 Busulfan + ATG
  • 7 Busulfan +ATG
  • 6 Busulfan
  • 5 Thiotepa
  • 4 Thiotepa
  • 3 Cyclophosphamide
  • 2 Cyclophosphamide
  • 1 0 Transplant with alpha beta T cell depleted stem cells
Device: Alpha Beta T cell depletion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe acute and chronic graft versus host disease (GVHD)
Time Frame: 1 year
Estimation of the incidence and extent of acute and chronic GVHD. The overall incidence of acute GVHD, the incidence of Grade 4 acute GVHD and the incidence of chronic GVHD.
1 year

Collaborators and Investigators

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

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Nancy J Bunin, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2014

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimated)

December 24, 2014

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-010495
  • BT13BTθ51 (Other Identifier: The Children's Hospital of Philadelphia)

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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