A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65-80
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The researchers are doing this study to find out if the study treatment is an effective treatment that causes few or mild side effects in people with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. The treatment being tested in this study is glofitamab, polatuzumab, and obinutuzumab in combination with standard treatment (the combination of rituximab, cyclophosphamide, doxorubicin, and prednisone, or R-miniCHP).
Eligibility criteria
Qualifiers
Age 65-79 years with a fitness assessment of unfit or frail per simplified GA (Appendix 1, www.filinf.it/epi)
Age ≥80 years with any fitness level
Pathologically confirmed DLBCL, HGBCL or transformed lymphoma
No prior systemic anti-lymphoma therapy (prednisone/equivalent up to 100 mg daily x 7 days is permissible)
Disqualifiers
Prior systemic anti-lymphoma therapy (localized radiation, steroids and antibiotics are permitted)
Prior solid organ transplantation
Prior allogeneic stem cell transplantation
Active CNS involvement
Trial design
Treatments tested in this trial
- Glofitamab
- Polatuzumab
- Rituximab
- Cyclophosphamide
- Doxorubicin
- Obinutuzumab:
Treatment groups
42 Participants
are divided into 1 treatment groupLocations
8Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920, Basking RidgeNew Jersey, United States
Hackensack Meridian Health (Data collection only)07601, HackensackNew Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645, MontvaleNew Jersey, United States
Sponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov