Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device
April 27, 2026 updated by: Julie-An M. Talano
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
-
-
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:
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
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: Single Experimental Arm
Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device
|
Depletion of Alpha Beta T cells in the PBSC graft
Other Names:
|
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.
Time Frame: DAY 42
|
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).
Time Frame: 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.
|
1 year
|
|
Estimate the incidence and extent of acute and chronic graft vs. host disease.
Time Frame: 1 year
|
Acute GVHD will be graded using the standard Glucksberg grading system.
|
1 year
|
|
Assess the incidence treatment-related mortality (TRM).
Time Frame: 1 year
|
TRM is defined as death from non-disease related causes in the 100 days from stem cell infusion.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie-An Talano, MD, 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
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
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
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.