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

Stanford University

Status: Completed

Conditions: Graft vs Host Disease

Treatments: Drug: Cyclosporine A; Drug: Prednisone; Drug: Rituximab; Drug: tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00350545

96950 (Other Identifier)

IRB-04948

NCI-2011-00450 (Other Identifier)

BMT177 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 1 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

rituximab + prednisone arm

Experimental group

Description:

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.

Treatment:

Drug: tacrolimus

Drug: Rituximab

Drug: Prednisone

Drug: Cyclosporine A