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

Completed · Phase 1/Phase 2

Conditions studied: Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell

In brief

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).

Key facts

Study ID: NCT02733042
Run by: Celgene
People needed: 106
Starts: 2016-05-11
Expected to finish: 2022-08-21
Last updated by the study team: 2023-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject who has histologically confirmed and documented B-cell lymphoma (eg, follicular, diffuse large B-cell, mantle cell, small lymphocytic, or Hodgkin lymphoma) and chronic lymphocytic leukemia.
Subject who has high-risk chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Subject who was previously treated with at least one prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
Subject who has the Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
Subject who is willing and able to undergo biopsy.
Subject who has documented active relapsed or refractory disease requiring therapeutic intervention.
Subject with lymphoma who has measurable disease (≥ 2.0 cm in its longest dimension by computed tomography) or chronic lymphocytic leukemia in need of treatment.
Subject who fulfills the laboratory requirements as per protocol

You may not qualify if…

Subject who has central nervous system (CNS) or meningeal involvement by lymphoma.
Subject who has any histopathologic finding consistent with myelodysplastic syndrome on bone marrow studies.
Subject who received any prior monoclonal antibodies against programmed cell death-1 (PD-1) or programmed cell death ligand-1 (PD-L1) and/or any prior:
Arm A only: drugs with immunomodulatory and other properties (eg, lenalidomide, thalidomide);
Arm B only: ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor;
Arms C only: bendamustine
Subject who has active auto-immune disease.
Subject who has history of organ transplant or allogeneic hematopoietic stem cell transplantation.
Subject who is seropositive for or active viral infection with hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive and/or detectable viral DNA)
Subject who has known seropositivity for or active infection for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
Subject who has history of primary immunodeficiency or tuberculosis.
Subject who other invasive malignancy within 2 years (5 years for Arm A) except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured.

Where it is running

Pinnacle Oncology Hematology — Scottsdale, Arizona, United States
University of Colorado Cancer Center — Aurora, Colorado, United States
Shands Cancer Center University of Florida — Gainesville, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
Mayo Clinic — Rochester, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
Weill Cornell Medical College — New York, New York, United States
Local Institution - 005 — Rochester, New York, United States
University of Rochester — Rochester, New York, United States
The Ohio State University — Columbus, Ohio, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
Jefferson Medical Oncology Associates — Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center — Houston, Texas, United States
Houston Methodist Cancer Center — Houston, Texas, United States
MD Anderson Cancer Center — Houston, Texas, United States
Centre Hospitalier Universitaire d'Avicennes — Bobigny, France
Hopital Henri Mondor — Créteil, France
Centre Hospitalier — Dijon, France
Institut Paoli Calmettes — Marseille, France
CHU Montpellier — Montpellier, France
Local Institution - 102 — Montpellier, France
Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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