Ibrutinib Plus Rituximab for cGVHD Following Allo-SCT
Status:
Terminated
Trial end date:
2021-09-20
Target enrollment:
Participant gender:
Summary
Allogeneic stem cell transplant is used to treat a variety of blood cancers. However,
graft-versus-host disease (GVHD) is a common condition that may occur after transplant. GVHD
happens when the donor cells attack and damage the recipients' tissue.
The standard medication to treat chronic graft-versus-host-disease (cGVHD) is
corticosteroids. However, there are long-term side effects of steroid therapy, including risk
of infection, bone loss and other health problems. In addition, some patients with cGVHD do
not respond to standard steroid therapy. In these cases, medications to suppress the immune
system may be used.
The purpose of this study is to learn about the effects, both good and bad, of combining the
drugs ibrutinib and rituximab for the treatment of cGVHD.
Ibrutinib is Food and Drug Administration (FDA)-approved for the treatment of cGVHD which has
not responded to steroid therapy.
Rituximab is an investigational drug, which means it is not FDA approved for this particular
use. Rituximab is currently approved for treatment of Non-Hodgkin's Lymphoma (NHL), Chronic
Lymphocytic Leukemia (CLL), and other conditions, but is not FDA approved for the treatment
of cGVHD.
However, rituximab has been used in a clinic setting for the treatment of cGVHD in a number
of patients over the past few years, and has generally been well tolerated and shown some
benefit.
The combination of ibrutinib and rituximab is being studied in the treatment of certain types
of lymphoma and chronic leukemia, but it has not yet been combined for patients with cGVHD.
Because ibrutinib is not approved for this use when combined with rituximab, it is considered
investigational in this study.
In this form, the term "study drug" refers to ibrutinib and rituximab.
This study will involve people who have chronic GVHD, have previously taken corticosteroids,
and have either not benefited from treatment with corticosteroids or have been unable to
successfully taper off steroids.