A PHASE 2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE SAFETY AND CLINICAL ACTIVITY OF DURVALUMAB IN COMBINATION WITH RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, PREDNISONE (R-CHOP) OR WITH LENALIDOMIDE PLUS R CHOP (R2 CHOP) IN SUBJECTS WITH PREVIOUSLY UNTREATED, HIGH RISK DIFFUSE LARGE B CELL LYMPHOMA

Trial Profile

A PHASE 2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE SAFETY AND CLINICAL ACTIVITY OF DURVALUMAB IN COMBINATION WITH RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, PREDNISONE (R-CHOP) OR WITH LENALIDOMIDE PLUS R CHOP (R2 CHOP) IN SUBJECTS WITH PREVIOUSLY UNTREATED, HIGH RISK DIFFUSE LARGE B CELL LYMPHOMA

Suspended
Phase of Trial: Phase II

Latest Information Update: 06 Dec 2017

At a glance

  • Drugs Durvalumab (Primary) ; Lenalidomide (Primary) ; Cyclophosphamide; Doxorubicin; Prednisolone; Prednisolone; Prednisone; Prednisone; Rituximab; Vincristine
  • Indications Diffuse large B cell lymphoma
  • Focus Therapeutic Use
  • Sponsors Celgene Corporation; Celgene International SARL
  • Most Recent Events

    • 07 Sep 2017 According to a Celgene Corporation media release, the US FDA has placed a partial clinical hold on this trial, based on risks identified in other trials for an anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma in combination with immunomodulatory agents.
    • 07 Sep 2017 Status changed from recruiting to suspended, according to a Celgene Corporation media release.
    • 06 Jun 2017 According to trial design presented at the 53rd Annual Meeting of the American Society of Clinical Oncology, exploratory endpoints of this study includes progression-free survival at 12 months, complete response, pharmacokinetics and pharmacodynamics.
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