Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease

• ClinicalTrials.gov Identifier: NCT00136396
• Recruitment Status: Completed
• First Posted: August 29, 2005
• Last Update Posted: June 12, 2013
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: Brigham and Women's Hospital
• Information provided by (Responsible Party): Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute

Study Description

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.

Study Design

• 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

Arms and Interventions

Intervention Details:

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Corey S. Cutler, MD, MPH; Dana-Farber Cancer Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cutler C, Miklos D, Kim HT, Treister N, Woo SB, Bienfang D, Klickstein LB, Levin J, Miller K, Reynolds C, Macdonell R, Pasek M, Lee SJ, Ho V, Soiffer R, Antin JH, Ritz J, Alyea E. Rituximab for steroid-refractory chronic graft-versus-host disease. Blood. 2006 Jul 15;108(2):756-62. Epub 2006 Mar 21.

• Responsible Party: Corey S. Cutler, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT00136396
• Other Study ID Numbers: 03-120
• First Posted: August 29, 2005
• 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; GVHD; steroid-refractory; rituximab

Additional relevant MeSH terms:

Graft vs Host Disease; Immune System Diseases; Rituximab; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents