B-cell non-Hodgkin lymphoma (NHL)
Conditions
Brief summary
1. Occurrence and severity of adverse events, including DLTs (Phase Ib), 2. Change from baseline in targeted vital signs (Phase Ib), 3. Change from baseline in targeted clinical laboratory test results (Phase Ib), 4. CR rate at the time of PRA as determined by the investigator (Phase Ib), 5. Best ORR as determined by the investigator (Phase Ib), 6. DOR as determined by the investigator (Phase Ib), 7. Best ORR, as determined by the IRC (Phase II)
Detailed description
1. Best ORR as determined by the investigator (Phase II), 2. Best CR rate as determined by the investigator and IRC (Phase II), 3. CR rate at the time of PRA as determined by the investigator and IRC (Phase II), 4. ORR at the time of PRA as determined by the investigator and IRC (Phase II), 5. DOR as determined by the investigator and IRC (Phase II), 6. PFS as determined by the investigator and IRC (Phase II), 7. EFS as determined by the investigator and IRC (Phase II), 8. OS (Phase II), 9. Occurrence and severity of adverse events (Phase II), 10. Change from baseline in targeted vital signs (Phase II), 11. Change from baseline in targeted clinical laboratory test results (Phase II), 12. Maximum serum concentration (Cmax) for Mosun (Phase Ib and II), 13. Minimum serum concentration (Cmin) for Mosun (Phase Ib and II), 14. Total exposure area under the concentration-time curve (AUC) for Mosun (Phase Ib and II), 15. Clearance for Mosun (Phase Ib and II), 16. Volume of distribution for Mosun (Phase Ib and II), 17. Relationship between ADA status and efficacy, safety, pharmacokinetics, and biomarkers (Phase Ib and II)
Interventions
DRUGPREDNISONE
DRUGRASBURICASE
DRUGMosunetuzumab
DRUGPARACETAMOL
DRUGPEGFILGRASTIM
DRUGRoActemra 20 mg/mL concentrate for solution for infusion
DRUGDEXAMETHASONE
DRUGDIPHENHYDRAMINE
DRUGMabThera 500 mg concentrate for solution for infusion
DRUGALLOPURINOL
DRUGMETHYLPREDNISOLONE
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Occurrence and severity of adverse events, including DLTs (Phase Ib), 2. Change from baseline in targeted vital signs (Phase Ib), 3. Change from baseline in targeted clinical laboratory test results (Phase Ib), 4. CR rate at the time of PRA as determined by the investigator (Phase Ib), 5. Best ORR as determined by the investigator (Phase Ib), 6. DOR as determined by the investigator (Phase Ib), 7. Best ORR, as determined by the IRC (Phase II) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Best ORR as determined by the investigator (Phase II), 2. Best CR rate as determined by the investigator and IRC (Phase II), 3. CR rate at the time of PRA as determined by the investigator and IRC (Phase II), 4. ORR at the time of PRA as determined by the investigator and IRC (Phase II), 5. DOR as determined by the investigator and IRC (Phase II), 6. PFS as determined by the investigator and IRC (Phase II), 7. EFS as determined by the investigator and IRC (Phase II), 8. OS (Phase II), 9. Occurrence and severity of adverse events (Phase II), 10. Change from baseline in targeted vital signs (Phase II), 11. Change from baseline in targeted clinical laboratory test results (Phase II), 12. Maximum serum concentration (Cmax) for Mosun (Phase Ib and II), 13. Minimum serum concentration (Cmin) for Mosun (Phase Ib and II), 14. Total exposure area under the concentration-time curve (AUC) for Mosun (Phase Ib and II), 15. Clearance for Mosun (Phase Ib and II), 16. Volume of distribution for Mos | — |
Countries
Belgium, Spain
Outcome results
None listed