Clinical trial NCT03016000: Thalidomide Maintenance Treatment in DLBCL
Official title: A Multicentre, Randomized Phase III Study of Thalidomide Maintenance Treatment in Patients With Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: diffuse large B-cell lymphoma
Thalidomide
Maintenance
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relapse-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Incidence of treatment-emergent adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Ru Feng
state: Guangdong
Study officials:
affiliation: Department of Hematology, Nanfang Hospital, Southern Medical University
name: Ru Feng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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