Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma

Arms (1)

1. type

   EXPERIMENTAL

   label

   Fludarabine + Melphalan with PBPC

   description

   Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m\^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.

   interventionNames

   1. Drug: Fludarabine
   2. Drug: Melphalan
   3. Procedure: Allogeneic Transplant
   4. Drug: Thymoglobulin

Primary outcomes (1)

1. measure

   Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)

   timeFrame

   Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.

   description

   Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( \> 90% to \< 100%); only traces of disease remains; 2) Significant improvement ( \> 75% to \< 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( \> 50% to \< 75%); 4) Some improvement ( \> 25% to \< 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+\<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by \> 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one.