Clinical Trial: A Study of Obinutuzumab for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Randomized Phase 2 Study of Obinutuzumab for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation

Brief Summary: This research study is studying a drug called obinutuzumab as a means of preventing chronic Graft vs. Host Disease (cGVHD).

Detailed Summary:

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
Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: The Rate Of Corticosteroid-Requiring cGVHD At One Year From HCT [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall cGVHD Rate After HCT [ Time Frame: at 1 year and at 2 years ]
  • 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 ]
  • Cumulative Incidence Of Non-Relapse Mortality And Relapse [ Time Frame: at 1 year and at 2 years ]


Original Secondary Outcome:

  • Overall cGVHD Rate After HCT [ Time Frame: at 1 year and at 2 years ]
  • Immunosuppression-Free Survival 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 ]
  • Cumulative Incidence Of Non-Relapse Mortality And Relapse [ Time Frame: at 1 year and at 2 years ]


Information By: Dana-Farber Cancer Institute

Dates:
Date Received: August 11, 2016
Date Started: September 2016
Date Completion: February 2024
Last Updated: August 12, 2016
Last Verified: August 2016