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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hematologic Malignancies

Intervention / Treatment
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* Biological: CliniMACs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 23 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Experimental Arm<br>Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device | Biological: CliniMACs<br>* Depletion of Alpha Beta T cells in the PBSC graft<br>* Other names: Alpha/Beta T-Cell Depletion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |