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

Phase 2

Active, not recruiting

• Conditions: Hematologic Malignancies
• Interventions: Biological: CliniMACs

• Registration Number: NCT02600208
• Lead Sponsor: Julie-An M. Talano

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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Experimental Arm	CliniMACs	Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device

Primary Outcome Measures

Name	Time	Method
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.	DAY 42	Engraftment will be defined using the standard CIBMTR definition of ANC \>500 for the first of 3 consecutive days.

Secondary Outcome Measures

Name	Time	Method
Assess the incidence treatment-related mortality (TRM).	1 year	TRM is defined as death from non-disease related causes in the 100 days from stem cell infusion.
Assess the probability of one year leukemia free survival (LFS).	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.
Estimate the incidence and extent of acute and chronic graft vs. host disease.	1 year	Acute GVHD will be graded using the standard Glucksberg grading system.

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States