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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Durvalumab intravenous 1500 mg
Lenalidomide oral 20 mg/day
National University Hospital Singapore
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore
Raffles Hospital Singapore
Singapore, Singapore
Efficacy as measured by overall response rate measured at the time of best response.
Overall response rate (ORR) is defined as the proportion of patients with reduction in tumor burden of at least 50%.
Time frame: 2 years
Progression-free survival (PFS)
PFS is defined as the time from enrolment to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.
Time frame: 2 years
Overall survival (OS)
OS is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: 2 years
Time-to-response (TTR)
Defined for all evaluable patients who have achieved an overall response as the date at which the patient's objective status is first noted to be a CR or PR.
Time frame: 2 years
Duration of response (DoR)
Defined for all evaluable patients who have achieved an overall response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented.
Time frame: 2 years
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