Rituximab for Prevention of Chronic GVHD

Completed · Phase 1/Phase 2

Conditions studied: Hematological Malignancies

In brief

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 can occur after bone marrow or stem cells are transplanted form 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. Rituximab is a drug that interferes with the immune system function by specifically targeting B cells and killing them.

Key facts

Study ID

NCT00379587

Run by

Dana-Farber Cancer Institute

People needed

65

Starts

2006-09-01

Expected to finish

2012-08-01

Last updated by the study team

2014-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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