Thalidomide Maintenance Treatment in DLBCL

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 3

Conditions: Lymphoma, Large B-Cell, Diffuse

Treatments: Drug: Thalidomide; Other: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT03016000

NFL2016-B2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 226 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

226 participants in 2 patient groups

Thalidomide

Experimental group

Description:

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.

Treatment:

Drug: Thalidomide

Observation

Other group

Description:

Observation

Treatment:

Other: Observation