Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease

NCT ID: NCT00136396

Last Updated: 2013-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2010-11-30

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).

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.

Conditions

Graft vs Host Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Rituximab

Given once weekly for 4 weeks followed by a 4 week observation therapy.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Corey S. Cutler, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Corey S. Cutler, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

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. doi: 10.1182/blood-2006-01-0233. Epub 2006 Mar 21.

Reference Type: DERIVED

PMID: 16551963 (View on PubMed)

Other Identifiers

03-120

Identifier Type: -

Identifier Source: org_study_id