Thalidomide Maintenance Treatment in DLBCL
Thalidomide Maintenance Treatment in DLBCL
This is a randomized, multi-center,phase III study to evaluate the ability of thalidomide
 maintenance therapy to prolong relapse-free survival in diffuse large B cell lymphoma(DLBCL).
This is a randomized, phase III study to evaluate the ability of thalidomide maintenance
 therapy to prolong relapse-free survival(RFS), in diffuse large B cell
 lymphoma(DLBCL).Patients will be enrolled after successful standard induction therapy (CR or
 CRu following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like
 chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the
 protocol. To evaluate the clinical efficacy of thalidomide maintenance therapy as compared to
 observation in patients with DLBCL who have achieved a complete remission after appropriate
 first-line therapy, measured by RFS, 226 patients with DLCBL will be recruited.
Inclusion Criteria:

 -  NCCN-IPI>1,

 -  Known IPI, cell of origin and DHL at time of diagnosis,

 -  Negative pregnancy test,

 -  Men must agree not to father a child during the therapy,

 -  6 to 8 cycles R-CHOP/like, total of 8 x Rituximab,

 -  CR, CRu

 Exclusion Criteria:

 -  Transformed lymphoma,

 -  Secondary malignancy,

 -  HIV positive,

 -  Evidence of CNS involvement,

 -  Cardiac dysfunction (systolic ejection fraction <50%),

 -  Creatinine > 2.0 mg/dl