A Study of Rituximab Combined With Prednisone for the Initial Treatment of Chronic Graft Versus Host Disease (cGVHD)

NCT01066598 | Terminated Phase 2

• 1 other identifier: OZM-009 (GVHD-R01)
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine the efficacy of the combination of rituximab and prednisone as initial therapy for chronic graft-versus-host disease (C-GVHD).

Conditions

Graft Versus Host Disease

Keywords

graft versus host disease; chronic graft versus host disease; cGVHD

Outcome Measures

Primary Outcomes (1)

• The efficacy of the combination of rituximab and prednisone as initial therapy for C-GVHD, which is defined as discontinuation of immunosuppressive therapy at 12 months with resolution of reversible manifestations of C-GVHD

  12 months

Secondary Outcomes (5)

• To determine the response rate to treatment, defined as complete response plus partial response (PR) for rituximab and prednisone

  3 years

• To determine the rate of recurrent C-GVHD following initial therapy with rituximab and prednisone

  3 years

• To determine the relapse rate of the underlying malignancy for which the allo-SCT was performed from time of study registration after treatment with rituximab and prednisone

  3 years

• To determine the rate of infection requiring treatment with anti-bacterial, anti-fungal or anti-viral therapy from time of study registration after treatment with rituximab and prednisone

  3 years

• To determine overall survival of treated patients from time of study registration to a maximum of 3 years following study registration for patients receiving rituximab and prednisone

  3 years

Study Arms (1)

Rituximab plus prednisone

EXPERIMENTAL

Rituximab 375 mg/m2 IV weekly X 4 doses + Prednisone 1 mg/kg/d Treat 61 Patients

Drug: Rituximab

Interventions

Rituximab DRUG

Rituximab 375 mg/m2 IV weekly X 4 doses + Prednisone 1 mg/kg/d

Also known as: Rituxan

Rituximab plus prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated symptomatic classical C-GVHD (with prior allogeneic stem cell transplant) requiring systemic therapy (defined as per NIH Consensus: a)At least 3 sites of organ involvement or individual organ score of at least 2, b)Patients on agents for GVHD prophylaxis (such as therapeutic dose or tapering cyclosporine A or tacrolimus) or patients that have received therapy for acute GVHD prior to enrollment are eligible
• Patients must be 18 years of age or older
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events response assessment and follow-up.
• Patient must be willing and able to complete the GVHD questionnaire
• For patients that have been started on prednisone therapy for cGVHD but otherwise meet all of the eligibility criteria, registration into this trial must occur no later than 14 days from the start of prednisone therapy.

You may not qualify if:

• Uncontrolled infection at the time of study enrollment
• Recurrent malignancy at the time of study enrollment
• Previous systemic therapy for C-GVHD, a)Patients on agents for GVHD prophylaxis (such as therapeutic dose or tapering cyclosporine A or tacrolimus) or patients that have received therapy for acute GVHD prior to enrollment are eligible. b)Patients who have been restarted on full doses of agents used for GVHD prophylaxis (ie. cyclosporine A or tacrolimus) after these have tapered or discontinued are not eligible
• Inability to tolerate prednisone (includes pre-existing myopathy, diabetes with poor glycemic control, uncontrolled hypertension or fluid retention) or rituximab
• Usage of additional concurrent agents which could treat C-GVHD (ie. chemotherapeutic agents - cyclophosphamide, methotrexate or other immunosuppressive agents). Patients may be continued on stable or tapering dose of GVHD prophylaxis agents such as cyclosporine or tacrolimus, but must be tapered off by first study treatment
• The administration of anticancer therapies or other investigational agents is not permitted. Use of hematopoietic colony stimulating factors to manage blood counts is allowed.
• Sexually active males and females of childbearing potential unwilling to practice contraception during the study. Patients of childbearing potential must be willing to use a reliable method of birth control (i.e. double barrier method).
• Women of childbearing potential with either a positive or no pregnancy test at baseline or lactating. Postmenopausal women must have been amenorrheic for at least 12 months or surgically sterile to be considered of non-childbearing potential.
• Patients with immune deficiency are at increased risk of lethal infections. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions.
• Patients with active hepatitis B are excluded

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Hoffmann-La Roche: collaborator

Study Sites (3)

Alberta Health Sciences - Tom Baker Cancer Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Princess Maragaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Graft vs Host Disease; Bronchiolitis Obliterans Syndrome

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John Kuruvilla

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 10, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 7, 2011

Record last verified: 2011-08

Locations

CA (3)