Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies

Study Overview
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Brief Summary
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This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with hematologic malignancies receiving alternative donor (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and graft versus host disease (GVHD), and one year leukemia free survival.

Official Title
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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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Leukemia, Lymphoma, Myelodysplasia

Intervention / Treatment
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* Device: Alpha Beta T cell depletion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Acceptable organ status clearance No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic Signed informed consent. Negative pregnancy test for females of childbearing potential. Exclusion Criteria: Patients who do not meet disease, organ or infectious criteria. No suitable donor Received previous allogeneic transplant Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.

Ages Eligible for Study
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Maximum Age: 23 Years

Sexes Eligible for Study
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All

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: intervention with device: Alpha Beta T cell depletion
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alpha Beta Total Body Irradiation - total body irradiation (TBI) first<br>Alpha Beta Total Body Irradiation - TBI first Day Treatment 11 Anti-thymocyte globulin (ATG) 10 ATG 9 ATG 8 TBI 7 TBI 6 TBI 5 Thiotepa 4 Thiotepa 3 Cyclophosphamide 2 Cyclophosphamide 1 Rest 0 Transplant with alpha beta T cell depleted stem cells | Device: Alpha Beta T cell depletion<br> <br> |
| Experimental: Alpha Beta Total Body Irradiation - TBI last<br>Alpha Beta Total Body Irradiation - TBI last Day Treatment 9 ATG 8 ATG 7 Thiotepa + ATG 6 Thiotepa 5 Cyclophosphamide 4 Cyclophosphamide 3 TBI 2 TBI 1 TBI 0 Transplant with alpha beta T cell depleted stem cells | Device: Alpha Beta T cell depletion<br> <br> |
| Experimental: Alpha Beta Non-irradiation regimen<br>Alpha Beta Non-irradiation regimen Day Treatment 9 Busulfan + ATG 8 Busulfan + ATG 7 Busulfan +ATG 6 Busulfan 5 Thiotepa 4 Thiotepa 3 Cyclophosphamide 2 Cyclophosphamide 1 0 Transplant with alpha beta T cell depleted stem cells | Device: Alpha Beta T cell depletion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe acute and chronic graft versus host disease (GVHD) | Estimation of the incidence and extent of acute and chronic GVHD. The overall incidence of acute GVHD, the incidence of Grade 4 acute GVHD and the incidence of chronic GVHD. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplant, Alternative Donor