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


About this study

This open-label, multicenter, global study is designed to determine the recommended phase 2 dose, safety, efficacy, and pharmacokinetics/pharmacodynamics of durvalumab in subjects with certain lymphoma subtypes or CLL. Globally, 265 subjects may be enrolled into 4 treatment arms, including durvalumab monotherapy; durvalumab in combination with lenalidomide± rituximab; ibrutinib; or rituximab ± bendamustine. The study will have 3 parts: dose finding, dose confirmation, and dose expansion. Subjects receiving monotherapy may receive combination therapy or involved-field radiation to a single nodal site at time of progressive disease.

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. 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.
  2. Subject who has high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma.
  3. Subject who was previously treated with at least one prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
  4. Subject who has the Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
  5. Subject who is willing and able to undergo biopsy.
  6. Subject who has documented active relapsed or refractory disease requiring therapeutic intervention.
  7. 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.
  8. Subject who fulfills the laboratory requirements as per protocol

Exclusion Criteria

  1. Subject who has central nervous system (CNS) or meningeal involvement by lymphoma.
  2. Subject who has any histopathologic finding consistent with myelodysplastic syndrome on bone marrow studies.
  3. Subject who received any prior monoclonal antibodies against PD-1 or PD-L1 and/or any prior:
    1. Arm A only: ImiDs (eg, lenalidomide, thalidomide);
    2. Arm B only: ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor;
    3. Arms C only: bendamustine
  4. Subject who has active auto-immune disease.
  5. Subject who has history of organ transplant or allogeneic hematopoietic stem cell transplantation.
  6. 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)
  7. Subject who has known seropositivity for or active infection for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
  8. Subject who has history of primary immunodeficiency or tuberculosis.
  9. 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.

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

Thomas Witzig, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


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