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

NCT02600208 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: BT13BTθ51
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assess the probability of one year leukemia free survival (LFS).

  1 year

• Estimate the incidence and extent of acute and chronic graft vs. host disease.

  1 year

• Assess the incidence treatment-related mortality (TRM).

  1 year

Study Arms (1)

Single Experimental Arm

EXPERIMENTAL

Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device

Device: CliniMACs

Interventions

CliniMACs DEVICE

Depletion of Alpha Beta T cells in the PBSC graft

Also known as: Alpha/Beta T-Cell Depletion

Single Experimental Arm

Eligibility Criteria

• Age: Up to 23 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• Patient
• Patients who do not meet disease, organ or infectious criteria.
• No suitable donor

Sponsors & Collaborators

• Julie-An M. Talano: lead
• Miltenyi Biotec, Inc.: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Julie-An Talano, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor - Department of Pediatrics - Division of Hematology/Oncology

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 9, 2015
• Study Start: October 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)