A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma
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
- Drug: Rituximab
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Lenalidomide
- Drug: Cyclophosphamide
- Drug: Prednisone
- Drug: Durvalumab
Celgene -- MEDI4736-DLBCL-001
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.
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
10. Active or prior documented autoimmune or inflammatory disorders within the past 3
11. Current or prior use of immunosuppressive medication within 28 days before start of
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (8)
|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|