Spots Global Cancer Trial Database for Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma

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Trial Identification

Brief Title: Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma

Official Title: A Phase II Study of Non-myeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) In Patients With Cutaneous T Cell Lymphoma

Study ID: NCT00896493

Conditions

Mycoses

Sezary Syndrome

Lymphoma, T-Cell, Cutaneous

Bone Marrow Transplant Failure

Lymphoma, Non-Hodgkin

Cutaneous T-cell Lymphoma

Interventions

anti-thymocyte globulin

cyclosporine

Lymphoid radiation

Study Description

Brief Summary: Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given that the median age at diagnosis is 55-60 years and frequently present compromised skin in these patients, which increases the risk of infection. Therefore, we propose a clinical study with allogeneic hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).

Detailed Description: Primary Objectives -To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival. Secondary Objectives -To evaluate the incidence and extent of acute and chronic graft-versus-host disease (GVHD) and time to engraftment.