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

Description

This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical activity, predictive biomarkers and pharmacokinetics/ pharmacodynamics of durvalumab in combination with R-CHOP (Arm A) or R2-CHOP (Arm B), followed by durvalumab consolidation therapy in previously untreated subjects with high-risk DLBCL. Patients with non-ABC subtype (determined by gene expression profiling) will be allocated to Arm A while patients with ABC (activated B-cell type) subtype will be allocated to Arm B. Approximately 120 patients may be enrolled and assigned into the appropriate treatment arms dependent upon their cell of origin status. Induction treatment with R-CHOP (± Lenalidomide) will last for a total of up to 6 to 8 treatment cycles (21 days cycle), and the total time on study treatment, including durvalumab consolidation, will last up to 12 months.

Study Start Date

February, 28 2017

Estimated Completion Date

July 2024

Interventions

  • Drug: Rituximab
  • Drug: Doxorubicin
  • Drug: Vincristine
  • Drug: Lenalidomide
  • Drug: Cyclophosphamide
  • Drug: Prednisone
  • Drug: Durvalumab

Study ID

Celgene -- MEDI4736-DLBCL-001

Status

Recruiting

Trial ID

NCT03003520

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

120

Sponsor

Celgene

Inclusion Criteria

    1. CD20+Diffuse Large B-Cell Lymphoma. 2. Ann Arbor stage 3 or 4 or stage 2 with bulky disease 3. High or high-intermediate disease risk. 4. No prior anti-lymphoma treatment. 5. Subject is willing and able to undergo biopsy. 6. Investigator considers R-CHOP immunochemotherapy appropriate. 7. ECOG performance status of 0-2. 8. Adequate hematology laboratory results (absolute neutrophil count ? 1.5 x 10^9/L, platelet count ? 75 x 10^9/L, hemoglobin ? 10.0 g/dL). 9. Adequate biochemistry laboratory results (AST/SGOT and ALT/SGPT ? 3.0 x upper limit of normal bilirubin ? 2.0 mg/dL creatinine clearance of ? 40 mL/min). 10. Bi-dimensionally measurable disease (> 2.0 cm). 11. Subject is using effective contraception.

Exclusion Criteria

    1. Diagnosis of lymphoma other than Diffuse Large B-Cell Lymphoma. 2. Composite lymphoma or transformed lymphoma. 3. Primary or secondary Central Nervous System involvement by lymphoma. 4. Seropositive or active viral infection with hepatitis B virus, human immunodeficiency virus or hepatitis C virus. 5. History of other malignancies, unless disease-free for ? 5 years. 6. Left ventricular ejection fraction < 50%. 7. Peripheral neuropathy ? Grade 2. 8. Prior use of lenalidomide, or monoclonal antibodies against CTLA-4, PD-1, or PD-L1. 9. High risk of developing thromboembolic events, who are unwilling to take venous thromboembolism prophylaxis. 10. Active or prior documented autoimmune or inflammatory disorders within the past 3 years. 11. Current or prior use of immunosuppressive medication within 28 days before start of treatment.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (8)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.6 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
Roswell Park Cancer Institute - Buffalo, New York 397.2 miles None None None
Mid Ohio Oncology Hematology Inc - Columbus, Ohio 637.3 miles None None None
Parkview Research Center - Fort Wayne, Indiana 727.2 miles None None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles None None None
Banner MD Anderson Cancer Center - Gilbert, Arizona 2,285.1 miles None None None
Swedish Cancer Institute - Seattle, Washington 2,489.6 miles None None None

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