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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02600208
Other study ID # BT13BT?51
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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