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Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00136396
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : June 12, 2013
Brigham and Women's Hospital
Information provided by (Responsible Party):
Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute

Brief Summary:
The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD).

Condition or disease Intervention/treatment Phase
Graft vs Host Disease Drug: Rituximab Phase 1 Phase 2

Detailed Description:

Patients will receive rituximab intravenously one time per week for four consecutive weeks. Once therapy is completed, the patient will have weekly visits with their physician for four more weeks, at which they will complete a simple questionnaire designed to evaluate the severity of chronic graft versus host disease.

At the end of the eighth week on the study (4 weeks of study treatment and 4 weeks of observation), patients will be evaluated to determine whether their chronic graft versus host disease (GVHD) has resolved.

If chronic graft versus host disease has resolved entirely, the patient will be monitored for the remainder of the year.

If after the initial eight weeks on the study the patient still has symptoms or signs of GVHD, they may receive a second four week study treatment.

If the patients' chronic GVHD reappears after receiving either one or two courses of rituximab, a third and final four week course of medication can be given provided it has been at least eight weeks since the last dose.

Blood tests will be performed at the beginning of the study, after 8 weeks on the study, after 16 weeks on the study and at the end of 1 year.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase I/II Trial of Rituximab Therapy for Steroid-Refractory Chronic Graft vs. Host Disease
Study Start Date : January 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2010

Intervention Details:
  • Drug: Rituximab
    Given once weekly for 4 weeks followed by a 4 week observation therapy.

Primary Outcome Measures :
  1. To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To determine the effects of rituximab therapy on quality of life of patients with steroid-refractory GVHD [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recipients of matched related, matched unrelated, or mismatched stem cell transplantation
  • At least 180 days since allogeneic stem cell transplantation procedure
  • Patients must have steroid-refractory chronic GVHD, defined as having persistent signs and symptoms despite the use of prednisone
  • Stable dose of corticosteroids for 4 weeks prior to enrollment
  • Adequate bone marrow function: absolute neutrophil count (ANC) > 500/mm; platelets > 20,000 ul
  • Adequate renal function: creatinine < 3.0 mg/dl
  • Adequate hepatic function: bilirubin < 3.0 mg/dl; AST < 90 IU

Exclusion Criteria:

  • Prednisone requirement greater than 2 mg/kg/day or equivalent
  • Known life-threatening sensitivity to rituximab or other anti-B cell antibody.
  • Prior exposure to any new immunosuppressive medication in the preceding 4 weeks prior to enrollment.
  • Active, uncontrolled infection
  • Evidence of natural exposure to hepatitis B or C.
  • Active malignant disease relapse
  • Donor lymphocyte infusion within the preceding 100 days.
  • Life expectancy of less than 3 months.
  • Pregnancy or lactation
  • Evidence of HIV seropositivity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00136396

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
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Principal Investigator: Corey S. Cutler, MD, MPH Dana-Farber Cancer Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Corey S. Cutler, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00136396    
Other Study ID Numbers: 03-120
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: June 2013
Keywords provided by Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute:
Steroid-refractory Chronic Graft vs. Host Disease
Chronic Graft vs. Host Disease
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents