Lymphoma, Large B-Cell, Diffuse
Conditions
Keywords
diffuse large B-cell lymphoma, Thalidomide, Maintenance
Brief summary
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).
Detailed description
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.
Interventions
DRUGThalidomide
Thalidomide 50mg daily by mouth( increase 25mg after 2 weeks if tolerated Until 200mg/day) until disease progression or intolerance due to AEs.The dose could be reduced if patient experienced grade 2 or higher AEs. Does reductions for AEs were recommended (200 mg daily to 100 mg daily, 100 mg daily to 50 mg daily).In patients intolerant of 50mg/ day, thalidomide discontinuation was allowed.
OTHERObservation
Just observation
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free survival | 5 years | RFS was defined as the time between randomization and any documentation of relapse, death by any cause or last follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | OS was defined as the interval from randomization to death or the last follow-up for surviving patients. |
| Incidence of treatment-emergent adverse events | 5 years | Adverse events were classified as defined by the National Cancer Institute Common Toxicity Criteria, version 2. Safety evaluations were focused especially on neurological symptoms and the development of deep venous thrombosis (DVT). |
Countries
China
Contacts
Primary ContactRu Feng, M.D.
Backup ContactXiaolei Wei, Ph.D.
Outcome results
None listed