Thalidomide Maintenance Treatment in DLBCL

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicentre, Randomized Phase III Study of Thalidomide Maintenance Treatment in Patients With Diffuse Large B-cell Lymphoma

Conditions
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Lymphoma, Large B-Cell, Diffuse

Intervention / Treatment
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* Drug: Thalidomide
* Other: Observation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thalidomide<br>Thalidomide 50mg daily by mouth( increase 50mg after 2 weeks if tolerated until 200mg/day) until disease progression or intolerance due to AEs.The dose could be reduced if the 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. | Drug: Thalidomide<br>* 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.<br>* Other names: Thalomid;|
| Other: Observation<br>Observation | Other: Observation<br>* Just observation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival | RFS was defined as the time between randomization and any documentation of relapse, death by any cause or last follow up. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS was defined as the interval from randomization to death or the last follow-up for surviving patients. | 5 years | 
| Incidence of treatment-emergent adverse events | 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). | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diffuse large B-cell lymphoma, Thalidomide, Maintenance