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

NCT03054532 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-02-16

No results posted yet for this study

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

Interventions

DRUG

Durvalumab

Durvalumab intravenous 1500 mg

DRUG

Lenali

Lenalidomide oral 20 mg/day

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Singapore General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2021-01-31
Completion
2021-07-31
FDA Drug
Yes

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03054532 on ClinicalTrials.gov