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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.
Enrollment
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Inclusion criteria
Histologically proven NK/T-cell lymphoma that has relapsed after at least one cycle of induction chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Previously treated with at least one cycle of chemotherapy that includes L-asparaginase or gemcitabine.
Must be aged ≥ 21 years and able to sign informed consent form.
Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow or hemophagocytic syndrome related to NKL) within 30 days prior to signing informed consent, including:
Must be able to adhere to study visit schedules and other protocol requirements.
Females of childbearing potential must:
Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or female of childbearing potential while participating in the study, during dose interruptions and for 28 days after discontinuation of study therapy, even if he has undergone successful vasectomy.
All patients must:
Male subjects should not donate sperm or semen while taking lenalidomide, during breaks (dose interruptions), and for at least 28 days after the last dose of lenalidomide.
Exclusion criteria
Primary purpose
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Interventional model
Masking
22 participants in 1 patient group
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Central trial contact
Colin Phipps, MD
Data sourced from clinicaltrials.gov
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