This phase II trial studies how well donor transplant, total lymphoid irradiation, and antithymocyte globulin works in treating patients with cutaneous T cell lymphoma. Giving total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also help the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and tacrolimus and mycophenolate mofetil after transplant may stop this from happening.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00896493.
PRIMARY OBJECTIVE:
I. To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival.
SECONDARY OBJECTIVE:
I. To evaluate the incidence and extent of acute and chronic graft-versus-host disease (GVHD) and time to engraftment.
OUTLINE:
NONMYELOABLATIVE REGIMEN: Patients undergo total lymphoid irradiation (TLI) on days -11 to -7 and on days -4 to -1. Patients also receive antithymocyte globulin intravenously (IV) on days -11 to -7. Patients who have extensive skin involvement such as spread plaques, tumors, or erythroderma with significant tumor infiltration undergo total skin electron beam therapy (TSEBT) as determined by the radiation oncologist and individualized based on the patient's presentation and treatment history.
TRANSPLANT: Patients* undergo allogeneic peripheral blood progenitor cell (PBPC) transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus orally (PO) twice daily (BID) on days -3 to 56 and mycophenolate mofetil PO BID on days 0 to 27 or 40 with a taper weekly until day 96.
NOTE*: Patients with persistent Sezary cells on day 28 have the option to start extracorporeal photopheresis (ECP) on day 30.
After completion of study treatment, patients are followed up for 2 years.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorWen-Kai Weng