A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination with Rituximab (R) or Obinutuzumab (G) and Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in patients with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase 1b dose-escalation stage and a Phase 2 stage. The anticipated time on treatment is 18-24 weeks.
Cancer (Oncology) - Lymphoma, Cancer (Oncology)
John Pagel, MD, PhD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed relapsed or refractory follicular lymphoma (Grades 1-3a) or relapsed or refractory diffuse large B-cell lymphoma
  • If the patient has received prior bendamustine, response duration must have been >1 year (for patients who have relapse disease after a prior regimen)
  • At least one bi-dimensionally measurable lesion on imaging scan defined as >1.5 cm in its longest dimension
  • Confirmed availability of archival or freshly collected tumor tissue
  • Life expectancy of at least 24 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Adequate hematological function unless inadequate function is due to underlying disease

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs, or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
  • Contraindication to bendamustine, rituximab, or obinutuzumab
  • Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks before Cycle 1 Day 1
  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
  • Ongoing corticosteroid use >30 mg/day prednisone or equivalent, for purposes other than lymphoma symptom control
  • Completion of autologous SCT within 100 days prior to Cycle 1 Day 1
  • Prior allogeneic SCT
  • Eligibility for autologous SCT (patients with relapsed/refractory DLBCL)
  • Grade 3b FL
  • History of transformation of indolent disease to DLBCL
  • Primary CNS lymphoma
  • Current Grade >1 peripheral neuropathy
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 4 weeks prior to Cycle 1 Day 1
  • Patients with suspected or latent tuberculosis
  • Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C virus (HCV) antibody
  • Known infection with HIV or human T-cell leukemia virus 1 (HTLV-1) virus
  • Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of rituximab or obinutuzumab
  • Evidence of laboratory abnormalities in standard renal, hepatic or coagulation function tests
(206) 215-3086