Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02867384|
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Graft vs. Host Disease||Drug: Obinutuzumab Drug: Placebo||Phase 2|
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.
The FDA (the U.S. Food and Drug Administration) has not approved Obinutuzumab for prevention of chronic Graft-vs.-Host Disease (cGVHD), but it has been approved for other uses.
In this research study, the investigators are aiming to determine the effect of Obinutuzumab on the incidence of corticosteroid-requiring cGVHD after allogeneic Hematopoetic Cell Transplant (aHCT).
Chronic GVHD is a medical condition that can occur after bone marrow or stem cells are transplanted from one individual to another. After the transplant, the donor immune system may recognize the recipient body as foreign and may attempt to 'reject' the body. This process is referred to as Graft-vs. -Host Disease and may occur at any time, although generally not earlier than one hundred days after transplantation.
The immune system produces two types of lymphocytes (white blood cells), B cells and T cells. B cells are part of the 'memory' for the immune system, and they make antibodies (proteins) when bacteria, viruses or other potentially harmful materials enter the body. Obinutuzumab is an antibody, a molecule that targets certain cells by binding to specific parts of the target cell. In this case, Obinutuzumab will bind to a component of B cells called CD20, resulting in the B cell getting killed. It is thought that reducing the number of B cells will reduce the chances of developing cGVHD after transplant. Previous studies with another antibody targeting CD20 on B cells suggests that there may be a reduced chance of developing cGVHD and the need to prescribe Corticosteroids to treat cGVHD when B cells are killed.
This is a randomized, placebo controlled trial. This means that approximately half of the study participants will receive Obinutuzumab, and the other half will receive a placebo (saline solution). A computer will decide which participants will receive Obinutuzumab or placebo, and neither the participant or the study doctor will know which the participant has received until the study is completed. It is important to note that the current standard is to receive no therapy specifically to prevent cGVHD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Phase 2 Study of Obinutuzumab for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation|
|Actual Study Start Date :||November 29, 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2024|
Active Comparator: Obinutuzumab
Obinutuzumab or will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation.
B cell depletion
Other Name: Gazyva
Sham Comparator: Placebo
Placebo will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation.
- The Rate Of Corticosteroid-Requiring cGVHD At One Year From HCT [ Time Frame: 1 year ]The primary endpoint of this phase II trial is the rate of corticosteroid-requiring cGVHD one year after HCT.
- Overall cGVHD Rate After HCT [ Time Frame: at 1 year and at 2 years ]A secondary endpoint of this phase II trial is the overall rate cGVHD one and two years after HCT.
- Immunosuppression-Free Survival (IFS) Rate [ Time Frame: at 1 year and at 2 years ]IFS is defined as time from randomization to relapse, institution of systemic immune suppression, or death, whichever occurs first.
- The Rate Of NIH Moderate-Severe cGVHD After HCT [ Time Frame: at 1 year and at 2 years ]A secondary endpoint is the rate of NIH Moderate-Severe cGVHD one and two years after HCT.
- Cumulative Incidence Of Non-Relapse Mortality And Relapse [ Time Frame: at 1 year and at 2 years ]A secondary endpoint is the cumulative incidence of non-relapse mortality and relapse one and two years after HCT.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867384
|Contact: Corey Cutler, MD MPH||617-632-3470|
|United States, California|
|Palo Alto, California, United States, 94305|
|Contact: David Miklos, MD|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Yi-Bin Chen, MD 617-726-5765|
|Principal Investigator: Yi-Bin Chen, MD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Correy Cutler, MD MPH 617-632-3470|
|Principal Investigator: Correy Cutler, MD MPH|
|United States, Minnesota|
|Masonic Cancer Center||Not yet recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Najla El Jurdi, MD 612-625-8942 firstname.lastname@example.org|
|Principal Investigator:||Corey Cutler, MD MPH||Dana-Farber Cancer Institute|