Status:
COMPLETED
Rituximab for Prevention of Chronic GVHD
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Genentech, Inc.
Biogen
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to determine if administration of rituximab after allogeneic stem cell transplantation can reduce the incidence of chronic GVHD. Chronic GVHD is a medical condition that c...
Detailed Description
Study Design: The study is designed as a Phase II, open label trial of Rituximab as chronic GVHD prophylaxis after HLA-matched, related or unrelated peripheral blood stem cell transplantation after ab...
Eligibility Criteria
Inclusion
- Patients who have undergone either ablative or non-myeloablative allogeneic stem cell transplantation
- Peripheral blood stem cells must have been used as the stem cell source
- Patients must have received transplantation from donors who are identical at 6 HLA loci, or mismatched at no more than 1 locus.
- Patients who have undergone a non-myeloablative stem cell transplant must have \> 80% donor hematopoiesis within 30 days of study enrollment
- 18 years of age or older
- Performance Status 0-2
- Life expectancy of \> 100 days
- Subjects with CLL are eligible, if there is no more than 20% residual leukemia in the bone marrow at the time of study entry
Exclusion
- Evidence of relapsed or residual malignancy within 30 days of trial entry
- Highly aggressive B cell malignancy, such as Burkitt's lymphoma or Burkitt's-like lymphoma
- Allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow
- Evidence of any active uncontrolled infection, or evidence of natural exposure to Hepatitis B, Hepatitis C or HIV
- Evidence of ongoing gastrointestinal or hepatic acute GVHD, or evidence of greater than ongoing Stage I cutaneous acute GVHD
- GVHD with chronic features diagnosed prior to day +100 or prior to enrollment
- Participation in a clinical trial evaluating another preventative strategy for chronic GVHD, or ongoing participation in a clinical trial for therapy of acute GVHD
- No Donor Lymphocyte Infusion (DLI) prior to day 100 and not plans for a DLI in the upcoming 30 days
- Heart failure uncontrolled by medications
- Pregnancy or lactation
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00379587
Start Date
September 1 2006
End Date
August 1 2012
Last Update
March 19 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115