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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematologic Malignancies
• Intervention / Treatment: Device: CliniMACs

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 23 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Experimental Arm; Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device	Device: CliniMACs; Depletion of Alpha Beta T cells in the PBSC graft; Other Names: Alpha/Beta T-Cell Depletion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	DAY 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
Estimate the incidence and extent of acute and chronic graft vs. host disease.	Acute GVHD will be graded using the standard Glucksberg grading system.	1 year
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.	1 year

Collaborators and Investigators

• Sponsor: Julie-An M. Talano
• Collaborators: Miltenyi Biotec, Inc.
• Investigators: Principal Investigator: Julie-An Talano, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: November 6, 2015
• First Posted (Estimated): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: BT13BTθ51 (The Children's Hospital of Philadelphia)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No