Rituximab for Prevention of Chronic GVHD

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00379587
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Hematological Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab at months 3, 6, 9 and 12 post-transplant
  • 375 mg/m2 RRituximab — DRUG
    Rituximab 375 mg/m2 q3months

Study Details

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 Dates

Start date
Sep 30, 2006
Status verified
Feb 2014
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
65 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Primary Outcome Measure

Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years [ Time Frame: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115-

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