Lenalidomide Plus Rituximab (R) in Non Follicular NHL

Sponsor
Gruppo Italiano Studio Linfomi
Study ID
NCT01830478
Phase
PHASE2
Status
Unknown

Conditions

  • Indolent Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    Lenalidomide 20 mg p.o. once daily, days 1-21 every 28 days, for 6 cycles
  • Rituximab — DRUG
    Rituximab 375 mg/m2 intravenously, day 14 of every course for 6 cycles

Study Details

The purpose of this study is to determine whether lenalidomide in association with rituximab is effective in the treatment of patients with indolent non follicular NHL relapsed after \>=2, but less than 4 prior lines of (immuno)chemotherapy.

Key Dates

Start date
Apr 30, 2009
Status verified
Apr 2013
Primary completion
Dec 31, 2010
Completion
Oct 31, 2014

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenalidomide and Rituximab
    Lenalidomide 20 mg once daily on days 1-21 of 28 days cycle for up to 6 courses and Rituximab 375 mg/m2 at day 14 of every course.

Primary Outcome Measure

Assess the efficacy [ Time Frame: Two weeks after the completion of Rituximab + Lenalidomide ]