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NCT Number: NCT02600208

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

Up to 23 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CliniMACS

Device

Depletion of Alpha Beta T cells in the PBSC graft

Other names: Alpha/Beta T-Cell Depletion

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.

    Time frame: DAY 42

    Engraftment will be defined using the standard CIBMTR definition of ANC >500 for the first of 3 consecutive days.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Julie-An M. Talano

Other

Collaborators

  • Miltenyi Biotec, Inc.

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Nov 9, 2015
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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