Efficacy of Lenalidomide in Combination With Subcutaneous Rituximab + miniCHOP in DLBCL Patients of 80 y/o or+

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT02128061
Phase
PHASE3
Status
Completed

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
80 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in patients aged 80 years old or more with not previously treated cluster of differentiation antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival (OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination of the R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP regimen.The statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS in favor of the experimental arm, as compared to the reference arm (R-miniCHOP).

Key Dates

Start date
Aug 31, 2014
Status verified
Mar 2020
Primary completion
Nov 5, 2018
Completion
Jan 31, 2021

Study Design

Enrollment
250 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: R-miniCHOP
    All patients will be treated with R-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV: 400 mg/m² Day 1 (D1) DOXORUBICINE IV : 25 mg/m² D1 VINCRISTINE IV : 1 mg Total Dose (TD) D1 PREDNISONE PO : 40 mg/m² D1 to D5 RITUXIMAB SC\* : 1400 mg TD D1 \*The first cycle of rituximab is delivered by IV at the dose of 375 mg/m2
  • Experimental: R2-miniCHOP
    All patients will be treated with R2-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV: 400 mg/m² D1 - DOXORUBICINE IV : 25 mg/m² D1 - VINCRISTINE IV : 1 mg TD D1 - PREDNISONE PO : 40 mg/m² D1 to D5 - RITUXIMAB SC\* : 1400 mg TD D1 LENALIDOMIDE PO\*\* :10 mg TD D1 to D14 \*The first cycle of rituximab is delivered by IV at the dose of 375 mg/m2

Primary Outcome Measure

The overall survival (OS) [ Time Frame: OS rates at 2 years ]

Related Studies