A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia

Phase 1/2 Completed 106 enrolled Celgene Corporation

Non-randomizedSequentialOpen-labelTreatment

Summary

This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).

Timeline

Start: 2016-05-11
Primary completion: 2019-03-06
Completion: 2022-08-21

Publications

Casulo C, Santoro A, Cartron G, Ando K, Munoz J, Le Gouill S, Izutsu K, Rule S, Lugtenburg P, Ruan J, Arcaini L, Casadebaig ML, Fox B, Kilavuz N, Rettby N, Dell'Aringa J, Taningco L, Delarue R, Czuczman M, Witzig T. Durvalumab as monotherapy and in combination therapy in patients with lymphoma or chronic lymphocytic leukemia: The FUSION NHL 001 trial. Cancer Rep (Hoboken). 2023 Jan;6(1):e1662. doi: 10.1002/cnr2.1662. Epub 2022 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bendamustine	Small molecule	70 mg/m2	Intravenous
Subject	Bendamustine	Small molecule	90 mg/m2	Intravenous
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Ibrutinib	Small molecule	280 mg	Oral
Subject	Ibrutinib	Small molecule	420 mg	Oral
Subject	Ibrutinib	Small molecule	560 mg	Oral
Subject	Lenalidomide	Other / unclassified	10 mg	Oral
Subject	Lenalidomide	Other / unclassified	15 mg	Oral
Subject	Lenalidomide	Other / unclassified	20 mg	Oral
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Subject	Rituximab	Monoclonal antibody	500 mg/m2	Intravenous

A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia

Summary

Timeline

Publications

Drugs

Indications