Phase II Study of Durvalumab in Combination With Lenalidomide in Relapsed/Refractory NK-T-cell Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Durvalumab
- Conditions
- LYMPHOMA
- Sponsor
- Singapore General Hospital
- Enrollment
- 22
- Locations
- 4
- Primary Endpoint
- Efficacy as measured by overall response rate measured at the time of best response.
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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-
- •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:
- •Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
- •Platelet count ≥ 50 x 109/L
- •Hemoglobin ≥ 8 g/dL
- •Must be able to adhere to study visit schedules and other protocol requirements.
- •Females of childbearing potential must:
Exclusion Criteria
- •Concomitant use of any other investigational agent.
- •Known infection with human immunodeficiency virus (HIV).
- •Patient has known clinically active hepatitis B; carriers of hepatitis B are permitted but need to be on appropriate anti-viral therapy or have regular hepatitis B DNA virus monitored as advised by a Gastroenterologist.
- •Subject has a calculated or measured creatinine clearance of \< 30 mL/minute.
- •Neuropathy \> Grade
- •Presence of CNS involvement by lymphoma.
- •Myocardial infarction within 6 months prior to enrolment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
- •Clinically significant active infection or uncontrolled intercurrent illness.
- •Pregnant or lactating females.
- •Coexistent second malignancy or history of prior malignancy within the preceding 3 years (excluding non-melanoma skin tumors or in situ carcinoma of the cervix).
Arms & Interventions
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.
Intervention: Durvalumab
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.
Intervention: Lenali
Outcomes
Primary Outcomes
Efficacy as measured by overall response rate measured at the time of best response.
Time Frame: 2 years
Overall response rate (ORR) is defined as the proportion of patients with reduction in tumor burden of at least 50%.
Secondary Outcomes
- Overall survival (OS)(2 years)
- Progression-free survival (PFS)(2 years)
- Time-to-response (TTR)(2 years)
- Duration of response (DoR)(2 years)