Phase II Study Comparing LR-GEM to R-GEM-P in Second-line Treatment of Diffuse Large B-cell Lymphoma (LEGEND)

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT02060656
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Gemcitabine — DRUG
    1000mg/m2 IV D1, D8, D15 every 28 days
  • Methylprednisolone — DRUG
    1000mg/m2 IV or PO D1-5 every 28 days
  • Rituximab — DRUG
    375mg/m2 IV D1, D15 every 28 days
  • Cisplatin — DRUG
    100mg/m2 IV D15 every 28 days
  • Lenalidomide — DRUG
    25mg PO D1-21 every 28 days

Study Details

This is a randomised, phase II open-labelled two-arm study comparing R-GEM-P and LR-GEM in second-line treatment of Diffuse Large B-cell lymphoma. Eligible patients will be randomised 1:1 between R-GEM-P and LR-GEM.

Key Dates

Start date
Sep 30, 2013
Status verified
Sep 2019
Primary completion
Feb 28, 2018
Completion
Aug 31, 2023

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control: R-GEM-P
    Rituximab,Gemcitabine, Methylprednisolone,Cisplatin.
  • Experimental: Experimental: LR-GEM
    Lenalidomide, Rituximab, Gemcitabine, Methylprednisolone

Primary Outcome Measure

Complete response rate (CRR) [ Time Frame: Approximatley after 12 weeks of randomisation ]

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