Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Lymphoma

Aggression

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Primary Central Nervous System Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Immunological

Chandramouli Nagarajan, MD FRCPath

PHASE II STUDY OF DURVALUMAB IN COMBINATION WITH LENALIDOMIDE IN RELAPSED/REFRACTORY EBV ASSOCIATED SUBTYPES OF DLBCL, PRIMARY CNS LYMPHOMA AND PRIMARY TESTICULAR DLBCL

Patients with relapsed refractory subtypes of DLBCL who fulfill the inclusion / exclusion criteria will be recruited to this trial and treated in this open label, phase 2 trial with the PDL1 inhibitor Durvalumab and Lenalidomide. The combination treatment will be given from the time of recruitment for 6 months when Lenalidomide will be stopped but Durvalumab will continue for a total of 2 years. Response will be assessed by PET / CT scans as per standard lugano criteria.

This is a multi-center, open-label, phase II study of Durvalumab in combination with Lenalidomide for treatment of relapsed/refractory EBV associated DLBCL subtypes, primary testicular lymphoma and primary CNS lymphoma using a Simon's Two-stage Minimax design. Simon's two-stage Minimax design will be used to investigate if the overall response rate (ORR) is at least 45% against a no-interest ORR of 20%.

In the first stage, 13 patients will be accrued. If there are 2 or fewer responses in these 13 patients, the study will be stopped. Otherwise, 8 additional patients will be accrued for a total of 21 patients.This design yields a type I error rate of 5% and power of 80% when the true response rate is 45%.

Study Of Durvalumab and Lenalidomide In R/R EBV Associated DLBCL Subtypes, Primary CNS And Testicular DLBCL

Phase II Study Of Durvalumab In Combination With Lenalidomide In Relapsed/Refractory EBV Associated Subtypes Of DLBCL, Primary CNS Lymphoma And Primary Testicular DLBCL - DuRIANS (Durvalumab Revlimid In Aggressive NHL Subtypes)

Overall response rate (ORR) is defined as the proportion of patients with reduction in tumor burden of at least 50%. ORR will be reported with corresponding 95% confidence intervals using the exact binomial method.

Progression-free survival (PFS) is defined as the time from enrolment to progression or death due to any cause.

Overall survival (OS) is defined as the time from registration to death due to any cause.

National Cancer Center Singapore, Singapore

National University Hospital, Singapore

Raffles Hospital, Singapore

Singapore General Hospital

Spots Global Cancer Trial Database for primary testicular lymphoma