Trials / Withdrawn
WithdrawnNCT03212807
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)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Singapore General Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab | Investigational Medicinal Product |
| DRUG | Lenalidomide | Investigational Medicinal Product |
Timeline
- Start date
- 2017-08-01
- Primary completion
- 2021-02-01
- Completion
- 2023-08-01
- First posted
- 2017-07-11
- Last updated
- 2018-09-13
Locations
4 sites across 1 country: Singapore
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03212807. Inclusion in this directory is not an endorsement.