NCT03054532

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• LYMPHOMA

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab intravenous 1500 mg
DRUG	Lenali	Lenalidomide oral 20 mg/day

Timeline

• Start date: 2017-07-01
• Primary completion: 2021-01-01
• Completion: 2021-07-01
• First posted: 2017-02-15
• Last updated: 2017-02-16

Locations

4 sites across 1 country: Singapore

Regulatory

• FDA-regulated drug study