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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Glofitamab
DrugC1D8 2.5 mg iv; C1D15 10 mg iv; C2D1-onwards: 30 mg iv, every 3 weeks
Polatuzumab
Drug1.8 mg/kg iv C1D1 onwards, every 3 weeks
Rituximab
Drug375 mg/m2 iv D1
Cyclophosphamide
Drug400 mg/m2 iv D1
Doxorubicin
Drug25 mg/m2 iv D1
Obinutuzumab:
Drug1000 mg iv C1D1 (7 days prior to glofitamab administration) single dose
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Obinutuzumab, Glofitamab and PolatuzumabExperimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
evaluate the complete response rate (CRR)
according to the 2014 Lugano Response Criteria
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov