Campath in Chronic GVHD

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The CD52 antigen, which is targeted by alemtuzumab, is highly expressed on mature T lymphocytes, monocytes and monocyte-derived dendritic cells as well as on mature B cells. Due to its more promiscuous effect on immune cells, alemtuzumab not only targets antibody producing B lymphocytes as does rituximab, but also targets alloreactive T lymphocytes and dendritic cells that also contribute to the complex pathogenesis of chronic GVHD.

Our hypothesis is that alemtuzumab will be effective in the treatment of chronic GVHD through its promiscuous depletion of alloreactive T lymphocytes, dendritic cells as well as antibody producing mature B-lymphocytes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Bayer; Genzyme, a Sanofi Company
• Treatments: Alemtuzumab

Criteria

Inclusion Criteria:

• Recipients of allogeneic stem cell transplantation using myeloablative or non-myeloablative conditioning regimens.

• Patients must be at least 180 days (6 months) from the allogeneic stem cell transplantation procedure.

• Patients must have steroid refractory chronic GVHD, defined as having persistent signs and symptoms of chronic GVHD despite the use of prednisone at < 0.5 mg/kg/day or 1 mg/kg every other day for at least 4 weeks in the preceding 12 months (or equivalent dosing of alternate corticosteroids) without complete resolution of signs and symptoms. Patients with either extensive chronic GVHD or limited chronic GVHD requiring systemic therapy are eligible.

• Stable dose of corticosteroids for 4 weeks prior to enrollment.

• Less than 2mg/kg/day prednisone use (or equivalent).

• No addition or subtraction of other immunosuppressive medications (e.g. calcineurin inhibitors, sirolimus, mycophenolate mofetil) for 4 weeks prior to enrollment. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug.

• Adequate bone marrow function indicated by:

• ANC>1000/mm3

• Platelets>50,000/mm3

• 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

Exclusion Criteria:

• Prednisone requirement>2mg/kg/day or equivalent

• Known life-threatening hypersensitivity to alemtuzumab, other anti-B cell or anti-T cell antibodies.

• Prior exposure to any new immunosuppressive medication (or Extra Corporeal Phototherapy) in the preceding 4 weeks prior to enrollment.

• Active, uncontrolled infection.

• History of Hepatitis B or C infection.

• Active malignant disease relapse.

• Donor lymphocyte infusion within the preceding 100 days or plan for donor lymphocyte infusion in the coming 3 months.

• Life expectancy <3 months.

• Pregnancy or lactation.

• Evidence of HIV seropositivity.

• Inability to comply with alemtuzumab treatment regimen.