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

Hematologic Malignancies Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02600208
• Other study ID #: BT13BT?51
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: October 2015
• Est. completion date: December 2026

Study information

• Verified date: July 2023
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 23 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Neoplasms

Intervention

Biological:
• CliniMACs
Depletion of Alpha Beta T cells in the PBSC graft

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Julie-An M. Talano	Miltenyi Biotec, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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