A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease

NCT ID: NCT00350545

Last Updated: 2017-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2014-10-31

Brief Summary

The addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, enable a more rapid and effective steroid taper.

Detailed Description

To determine the efficacy of Rituximab as first line of treatment of chronic GVHD. Efficacy will be defined as he ability to taper prednisone to a dose of 0.25 mg/kg per day by 6 months without clinical or GVHD relapse/ recurrence.

Conditions

Graft vs Host Disease

Study Design

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

Study Groups

rituximab + prednisone arm

Rituximab will be given as an IV fusion as initial treatment, followed by predisone (given during registration) which will be continued through-out trial and tapered off by physician. Cyclosporine A and tacrolimus will be used if chances of new diagnosis of chronic GVHD occur. Both drugs have no interaction with Rituxan, but will be tapered off after predisone is completely tapered.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9

Prednisone

Intervention Type: DRUG

1 mg/kg; po per day with taper

Cyclosporine A

Intervention Type: DRUG

trough 200-300 or lower; po

tacrolimus

Intervention Type: DRUG

trough 5-10 or lower; po

Interventions

Rituximab

375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9

Intervention Type: DRUG

Prednisone

1 mg/kg; po per day with taper

Intervention Type: DRUG

Cyclosporine A

trough 200-300 or lower; po

Intervention Type: DRUG

tacrolimus

trough 5-10 or lower; po

Intervention Type: DRUG

Other Intervention Names

Rituxan; Deltasone; Liquid Pred; Meticorten; Orasone; cyclosporine; Ciclosporin; FK-506; Fujimycin

Eligibility Criteria

Inclusion Criteria

• Children and adults with a new diagnosis of chronic GVHD- that requires systemic immunosuppressive treatment to a dose of 1mg/kg/day prednisone and who have undergone any type of donor hematopoietic cell graft or conditioning regimen.
• Stable doses of other immunosuppressive medications (e.g. calcineurin inhibitors, mycophenolate mofetil) for 2 weeks prior to enrollment. In addition, these other immunosuppressive medications should not be dose increased.
• Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
• All subjects must provide written informed consent.

Exclusion Criteria

• Known life-threatening hypersensitivity to Rituximab or other anti-B cell antibody.
• Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment. Persistent prednisone treatment of acute GVHD that is less than 1mg/kg is allowed.
• Active, uncontrolled infection- CMV reactivation is excluded (i.e. pneumonitis, colitis). Peripheral blood CMV reactivation is allowed as long as it is not associated with CMV disease and is responding to therapy.
• Known Hepatitis B surface Ag positive
• Active malignant disease relapse.
• Pregnancy
• Lactating
• Inability to comply with the Rituximab treatment regimen.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Miklos

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Sally Arai

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

96950

Identifier Type: OTHER

Identifier Source: secondary_id

BMT177

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00450

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-04948

Identifier Type: -

Identifier Source: org_study_id