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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Grzegorz Nowakowski, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

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CLS-20318103

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