Status:
COMPLETED
Rituximab for the Primary Treatment of Denovo Extensive Chronic Graft Versus Host Disease (GVHD)
Lead Sponsor:
Northside Hospital, Inc.
Collaborating Sponsors:
Blood and Marrow Transplant Group of Georgia
Conditions:
Chronic Graft-versus-host Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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-r...
Detailed Description
Although allogeneic hematopoietic stem cell transplantation (HSCT) remains an important curative therapy for many patients with hematological malignancies, treatment-related morbidity and mortality co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01161628
Start Date
April 1 2011
End Date
July 1 2015
Last Update
April 20 2016
Active Locations (1)
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1
Northside Hospital
Atlanta, Georgia, United States, 30342