SHS_492336 PAGJ CIMG 15253

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. A Phase 2 Study to Evaluate the Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics 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.

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.
Phase II
NCT02564744
Cancer
Hematologic
John Pagel, M.D.
ImmunoGen
Ngan Trinh
  • Swedish Medical Center