CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma
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|ClinicalTrials.gov Identifier: NCT02424968|
Recruitment Status : Recruiting
First Posted : April 23, 2015
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia B-Cell Non-Hodgkin Lymphoma Chronic Lymphocytic Leukemia Hodgkin Lymphoma Myelodysplastic Syndrome Myeloproliferative Neoplasm T-Cell Non-Hodgkin Lymphoma||Biological: Anti-Thymocyte Globulin Drug: Cyclosporine Drug: Mycophenolate Mofetil Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Procedure: Peripheral Blood Stem Cell Transplantation Biological: Therapeutic Allogeneic Lymphocytes Radiation: Total Nodal Irradiation||Phase 2|
I. To determine the rate of conversion to full donor chimerism (FDC) following a post transplant infusion (day 30-60) of freshly enriched allogeneic CD8+ memory T-cells in patients with acute myeloid leukemia (AML), non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), or Hodgkin lymphoma (HL), who received non-myeloablative total lymphoid irradiation (TLI) anti-thymocyte globulin (ATG) transplant conditioning.
I. To determine the risk of disease progression, overall and event free survival, and non-relapse mortality.
II. To determine the incidence of acute and chronic graft-versus-host disease (GVHD) following the infusion of allogeneic CD8+ memory T-cells.
Patients undergo TLI on days -11 to -7 and -4 to -1 and receive ATG per standard institutional practice on days -11 to -7. Patients also receive cyclosporine orally (PO) daily starting on day -3 and will continue for at least 6 months post-transplant. Patients undergo non-myeloablative allogeneic hematopoietic stem cell transplant (HSCT) on day 0. Patients also receive mycophenolate mofetil PO daily beginning on day 0 and continue until day 28. Based on the patient's status after the initial transplant, patients receive CD8+ memory T-cells intravenously (IV) over 10-20 minutes sometime between day 30 and day 60.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post Transplant Infusion of Allogeneic CD8 Memory T-Cells as Consolidative Therapy After Non-myeloablative Allogeneic Hematopoietic Cell Transplantation in Patients With Leukemia and Lymphoma|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Treatment (TLI, ATG, transplant, CD8+ memory T-cells)
Patients undergo TLI on days -11 to -7 and -4 to -1 and receive ATG per standard institutional practice on days -11 to -7. Patients also receive cyclosporine PO daily starting on day -3 and will continue for at least 6 months post-transplant. Patients undergo non-myeloablative allogeneic HSCT on day 0. Patients also receive mycophenolate mofetil PO daily beginning on day 0 and continue until day 28. Based on the patient's status after the initial transplant, patients receive CD8+ memory T-cells IV over 10-20 minutes sometime between day 30 and day 60.
Biological: Anti-Thymocyte Globulin
Given per standard institutional practice
Drug: Mycophenolate Mofetil
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Undergo nonmyeloablative allogeneic HSCT
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplant
Biological: Therapeutic Allogeneic Lymphocytes
Receive CD8+ memory T-cells via IV
Radiation: Total Nodal Irradiation
- Full dose donor chimerism (FDC) [ Time Frame: 3 months ]Proportion of patients with full dose donor chimerism within 3 months of receiving the CD8+ memory T cell infusion. FDC is defined as achieving ≥ 95% donor type in the CD3+ lineage or whole blood within 90 days of cell infusion.
- Event free survival [ Time Frame: 1 year ]
- Incidence of acute GVHD following the infusion of allogeneic CD8+ memory T cells [ Time Frame: Up to 30 days post-infusion ]
- Incidence of adverse events, defined as grade III IV toxicities, graded according to Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 60 days post-infusion ]
- Incidence of chronic GVHD following the infusion of allogeneic CD8+ memory T cells [ Time Frame: 1 year ]
- Non-relapse mortality [ Time Frame: 1 year ]
- Overall survival [ Time Frame: 1 year ]
- Time to disease progression [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424968
|Contact: Melanie Gaudinezfirstname.lastname@example.org|
|United States, California|
|Stanford University, School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Melanie Gaudinez 650-725-4983 email@example.com|
|Principal Investigator: Robert Lowsky|
|Principal Investigator:||Robert Lowsky||Stanford University|