A Phase 2 Study to Evaluate the Efficacy and Tolerability of IMGN529 in Combination With Rituximab in Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma and Other Forms of Non-Hodgkin's Lymphoma

A Multicenter Open-Label Phase 2 Study of IMGN529 in combination with rituximab in Patients with relapsed or refractory B-Cell lymphoma and Other Forms of Non-Hodgkin's Lymphoma.
Cancer (Oncology) - Lymphoma, Cancer (Oncology)
John Pagel, MD, PhD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed relapsed and/or refractory DLBCL, FL, MZL/MALT, MCL, or other Sponsor approved NHL subtypes.
  • Patients must have evaluable or measurable disease in accordance with the International Working Group Guidelines for Lymphoma.
  • Must have received at least one but no more than six prior treatment regimens. Prior treatment with an anti-CD20 agent, either alone or in combination, is allowed.
  • Men and women ≥18 years of age
  • Patients must have ECOG Performance Status 0 - 2.
  • Patients who are HBsAg + (must be PCR negative) who are taking antivirals.

Exclusion Criteria:

  • Patients with diagnosis of CLL or small lymphocytic lymphoma (SLL).
  • Patients with active hepatitis A, B or C infection or other uncontrolled intercurrent illness.
  • Women who are pregnant or breast feeding.
  • Patients who have received prior therapy with other anti-CD37-targeting antibody drug conjugates.
(206) 215-3086