Ex Vivo TCR αβ T Cell Depletion for Graft-Versus-Host Disease Prophylaxis in Mismatched Donor Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT03717480|
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : March 12, 2020
This research study is studying the removal of a subset of white blood cells (called alpha/beta T cells) from the donor product using a cell separation device before the product is transplanted into the participant.
The device used to remove the α/βT cells in this study is:
-CliniMACS® TCR α/β Reagent System
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancy||Device: ClinicMACs||Not Applicable|
Patients who receive an allogeneic (using another person as the donor) stem cell transplant (SCT) are at risk for developing graft-versus-host disease (GVHD).
The word "graft" refers to the donor blood cells that you will receive during the transplant. The word "host" refers to the person receiving the cells. GVHD is a complication of transplantation where the donor graft attacks and damages some of the participant's tissues.
GVHD may occur when the T cells (a type of white blood cell that helps protect the body from infection) from the donor react against normal tissues or organs in the body. There are two basic types of GVHD:
- Acute GVHD often occurs early (generally first 3-6 months after SCT) may affect skin, gastrointestinal tract (stomach and intestines) and liver.
- Chronic GVHD often occurs later (Usually after 3-6 months after SCT) and may affect many organs and significantly diminish quality of life.
To confirm the diagnosis of acute or chronic GVHD, the participant may be asked to have a biopsy (a small sample of the participant's tissue to look at under the microscope) of the skin, gut, or, rarely, the liver.
In this research study, the investigator are investigating a pre-transplant intervention aimed to prevent GVHD by processing the donor product with the Miltenyi CliniMACS TCR α/β Reagent System. The Reagent System will remove certain cells (called T-Cell Receptor (TCR) α/β positive T-cells) that are thought to cause GVHD from donor product before it is given to the participant. By selectively removing this specific type of T cells from the donor product, the investigators hope to reduce the risk for GVHD without reducing the efficacy of the transplant.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved CliniMACS α/β T cell depletion system for use in the US, but this system is approved by the European Medicines Agency (EMA) and used in Europe
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Ex Vivo TCR αβ T Cell Depletion for Graft-Versus-Host Disease (GVHD) Prophylaxis in Mismatched Donor Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies|
|Actual Study Start Date :||January 21, 2020|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||May 1, 2022|
Experimental: TCR α/β Reagent System
The Reagent System will remove certain cells (called T-Cell Receptor (TCR) α/β positive T-cells) that are thought to cause GVHD from donor product before it is given to participants
- Severe acute GVHD-free survival rate [ Time Frame: 100 Days ]Participant rate of severe acute GVHD-free survival will be assessed at 100 days post-SCT
- Number of participants with grades II-IV acute GVHD [ Time Frame: 2 years ]Grades II-IV acute GVHD will be assessed at 2 years post-SCT.
- Number of participants with chronic GVHD [ Time Frame: 2 years ]Number of participants with chronic GVHD will be assessed at 2 years post-SCT.
- Number of participants with GVHD and relapse free survival (GRFS) [ Time Frame: 2 years ]GRFS will be defined as alive without having experienced grade 3-4 acute GVHD, moderate/severe chronic GVHD, or relapse of underlying malignancy.
- Number of participants with immunosuppression-free survival [ Time Frame: 2 years ]Number of participants with immunosuppression-free survival will be assessed at 2 years post-SCT.
- Number of participants with hematologic recovery [ Time Frame: 2 years ]Hematologic recovery will be assessed in participants at 2 years post-SCT.
- Number of participants with immune reconstitution [ Time Frame: 2 years ]Immune reconstitution will be assessed in participants at 2 years post-SCT.
- Number of participants with disease relapse [ Time Frame: 2 years ]Disease relapse will be assessed in participants at 2 years post-SCT.
- Number of participants with transplant-related mortality [ Time Frame: 2 years ]Participant transplant-related mortality will be assessed at 2 years post-SCT.
- Number of participants with organ toxicity [ Time Frame: 2 years ]Participant organ toxicity will be assessed at 2 years post-SCT.
- Rates of infections [ Time Frame: 2 years ]Participant rate of infections will be assessed at 2 years post-SCT.
- Number of participants with relapse-free and overall survival [ Time Frame: 2 years ]Number of participants with relapse-free and overall survival will be assessed at 2 years post-SCT.
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): NCT03717480
|Contact: Vincent T Ho, MD||617-632-1943||Vincent_Ho@dfci.harvard.edu|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Vincent T Ho, MD 617-632-1943 Vincent_Ho@dfci.harvard.edu|
|Principal Investigator: Vincent T. Ho, MD|
|Principal Investigator:||Vincent T Ho, MD||Dana-Farber Cancer Institute|