A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma, Large B-Cell, Diffuse

In brief

This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical activity, and predictive biomarkers of durvalumab in combination with R-CHOP or R2-CHOP, followed by durvalumab consolidation therapy in previously untreated subjects with high-risk diffuse large B-cell lymphoma (DLBCL). Induction treatment with R-CHOP (± lenalidomide) will last for a total of up to 6 to 8 treatment cycles (21 day cycles), and the total time on study treatment, including durvalumab consolidation, will last up to 12 months. On 05-Sep-2017, the US FDA has issued a Partial Clinical Hold on this study resulting in the discontinuation of enrollment into Arm B (Durvalumab + Lenalidomide + R-CHOP). After the US FDA Partial Clinical Hold, new eligible participants have been enrolled in Arm A (Durvalumab + R-CHOP).

Key facts

Study ID: NCT03003520
Run by: Celgene
People needed: 46
Starts: 2017-02-28
Expected to finish: 2022-04-24
Last updated by the study team: 2023-05-22

Who can join

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

You may qualify if…

CD20+Diffuse Large B-Cell Lymphoma.
Ann Arbor stage 3 or 4 or stage 2 with bulky disease
High or high-intermediate disease risk.
No prior anti-lymphoma treatment.
Subject is willing and able to undergo biopsy.
Investigator considers R-CHOP immunochemotherapy appropriate.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Adequate hematology laboratory results (absolute neutrophil count ≥ 1.5 * 10\^9/L, platelet count ≥ 75 * 10\^9/L, hemoglobin ≥ 10.0 g/dL).
Adequate biochemistry laboratory results (aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3.0 * upper limit of normal; bilirubin ≤ 2.0 mg/dL; creatinine clearance of ≥ 40 mL/min).
Bi-dimensionally measurable disease (> 2.0 cm).
Subject is using effective contraception.

You may not qualify if…

Diagnosis of lymphoma other than Diffuse Large B-Cell Lymphoma.
Composite lymphoma or transformed lymphoma.
Primary or secondary Central Nervous System involvement by lymphoma.
Seropositive or active viral infection with hepatitis B virus, human immunodeficiency virus or hepatitis C virus.
History of other malignancies, unless disease-free for ≥ 5 years.
Left ventricular ejection fraction < 50%.
Peripheral neuropathy ≥ Grade 2.
Prior use of lenalidomide, or monoclonal antibodies against CTLA-4, PD-1, or PD-L1.
High risk of developing thromboembolic events, who are unwilling to take venous thromboembolism prophylaxis.
Active or prior documented autoimmune or inflammatory disorders within the past 3 years.
Current or prior use of immunosuppressive medication within 28 days before start of treatment.

Where it is running

Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
Parkview Research Center — Fort Wayne, Indiana, United States
Mayo Clinic — Rochester, Minnesota, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
University of Rochester Medical Center — Rochester, New York, United States
Mid Ohio Oncology Hematology Inc — Columbus, Ohio, United States
Swedish Cancer Institute — Seattle, Washington, United States
Innsbruck Medical University Department of Internal Medicine — Innsbruck, Austria
Landeskrankenhaus Salzburg — Salzburg, Austria
Hanusch Krankenhaus — Vienna, Austria
Local Institution - 101 — Vienna, Austria
Medical University of Vienna Internalmedicine 1, Hematology — Vienna, Austria
Aarhus Sygehus — Arhus C, Denmark
Rigshospitalet, Kobenhavns Universitet - Centre for Clinical Intervention Research - The Copenhagen — Copenhagen, Denmark
Odense Universitetshospital — Odense C, Denmark
(North Estonia Medical Centre) - Onkoloogia-ja Hematoloogiakliinik — Tallinn, Estonia
Tartu University Hospital — Tartu, Estonia
University Hospital Birmingham — Birmingham, United Kingdom
Royal Marsden Hospital — London, United Kingdom
Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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