Phase II Study of Durvalumab in Combination With Lenalidomide in Relapsed/Refractory NK-T-cell Lymphoma

Sponsor
Singapore General Hospital
Study ID
NCT03054532
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab intravenous 1500 mg
  • Lenali — DRUG
    Lenalidomide oral 20 mg/day

Study Details

This is a multi-center, open-label, phase II study of durvalumab in combination with lenalidomide for treatment of relapsed/refractory NK/T-cell lymphoma (NKTCL). The study will employ a 2-stage Simon Optimal design with 80% power and type 1 error rate (significance level) of 5%. Stage 1 will involve 8 patients and will require at least 2 patients to achieve the primary end point of overall response in order to proceed onto to stage 2, which will have a target enrolment of 14 patients.

Key Dates

Start date
Jul 31, 2017
Status verified
Feb 2017
Primary completion
Jan 31, 2021
Completion
Jul 31, 2021

Study Design

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

Arms

  • Experimental: Durvalumab and lenalidomide
    Open-label use of 2 drugs: * Durvalumab 1500 mg intravenously on day 1 of a 28-day cycle until progressive disease or intolerance. * Lenalidomide orally on days 1 through 21 of each 28-day cycle for 6 cycles.

Primary Outcome Measure

Efficacy as measured by overall response rate measured at the time of best response. [ Time Frame: 2 years ]

Central Contacts

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