Print this page

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma.

Primary Objective:
- To evaluate the efficacy of glofitamab monotherapy compared with an investigators choice of BR or R-Len with respect to PFS.

Secondary Objectives:
- To evaluate the efficacy of glofitamab monotherapy compared with an investigator s choice of BR or R-Len with respect to CRR.

- To evaluate the efficacy of glofitamab monotherapy compared with an investigators choice of BR or R-Len with respect to ORR.

- To evaluate the efficacy of glofitamab monotherapy compared with an investigators choice of BR or R-Len with respect to OS.

- To evaluate the health-related quality of life of participants treated with glofitamab monotherapy compared with an investigator s choice of BR or R-Len.

Protocol Number: 012403
Phase: Phase III
Applicable Disease Sites: Non-Hodgkin's Lymphoma
Drugs Involved: BENDAMUSTINE
Gazyva (obinutuzumab)
Glofitamab
LENALIDOMIDE
RITUXIMAB
Tocilizumab
Principal Investigator: Matthew Matasar
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Monmouth Medical Center
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.