Study Of Durvalumab and Lenalidomide In R/R EBV Associated DLBCL Subtypes, Primary CNS And Testicular DLBCL (DuRIANS)
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|ClinicalTrials.gov Identifier: NCT03212807|
Recruitment Status : Withdrawn (FDA Hold for Combination Studies using Imids and PD1/PDL1 Compounds)
First Posted : July 11, 2017
Last Update Posted : September 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|EBV Related Non-Hodgkin's Lymphoma Primary CNS Lymphoma Primary Testicular Lymphoma||Drug: Durvalumab Drug: Lenalidomide||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Estimated Study Start Date :||August 2017|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||August 2023|
Durvalumab + Lenalidomide
Investigational Medicinal Product
Investigational Medicinal Product
- Overall Response Rate [ Time Frame: at least 6 months of follow up ]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 [ Time Frame: 12 months ]Progression-free survival (PFS) is defined as the time from enrolment to progression or death due to any cause.
- Overall Survival [ Time Frame: 2 years ]Overall survival (OS) is defined as the time from registration to death due to any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212807
|National Cancer Center|
|National University Hospital|
|Singapore General Hospital|
|Principal Investigator:||Chandramouli Nagarajan, MD FRCPath||Singapore General Hospital|