Rituximab for the Primary Treatment of Denovo Extensive Chronic Graft Versus Host Disease (GVHD)

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Rituximab is an attractive agent to bring to the upfront treatment of chronic graft-versus-host disease (cGVHD) due to its favorable toxicity profile, its proven efficacy in the treatment of steroid-refractory cGVHD, and its ability to serve as a steroid sparing agent in other autoimmune diseases. The investigators hope to demonstrate that Rituximab has significant activity in cGVHD when utilized early in the course of the process. In addition, the investigators hope to show that the early use of Rituximab may allow for the earlier discontinuation of immunosuppression while obviating the need for long courses of systemic corticosteroids, which should translate into reduced treatment-related morbidity and mortality associated with cGVHD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northside Hospital, Inc.
• Collaborator: Blood and Marrow Transplant Group of Georgia
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• First episode of extensive chronic GvHD, without residual or concurrent acute GvHD.

• Age 18 - 75

• Any primary diagnosis requiring treatment by allogeneic HSCT

• Recipient of an allogeneic stem cell transplant (bone marrow, peripheral blood stem cell, or cord blood) from a related or unrelated donor, minimum 80 days ago

• Conditioning regimen: Myeloablative or non-myeloablative

• Patient gives written informed consent

Exclusion Criteria:

• Creatinine > 2.0 mg/dl

• Uncontrolled, active infection

• Recurrent or progressive malignancy

• Anticipated life expectancy of less than 1 year

• Pregnant or breast feeding

• Contraindications to administration of the study intervention or known inability of the patient to tolerate the study intervention

• Patients with perceived fixed, irreversible defects (pulmonary involvement, contractures, etc.) which would not be expected to improve with the study intervention

• Residual or concurrent acute GVHD