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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Thomas Witzig, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20260194

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