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

Julie-An M. Talano

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Hematologic Malignancies

Treatments: Device: CliniMACs

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02600208

BT13BTθ51 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: Under 23 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Single Experimental Arm

Experimental group

Description:

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

Treatment:

Device: CliniMACs