Arm 1 for Non-Hodgkin's Lymphoma

Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia, Pisa, Italy
Non-Hodgkin's LymphomaCC-99282 - Drug
Eligibility
18+
All Sexes

Study Summary

This trialwill study how safe and effective mosunetuzumab and glofitamab are when combined with two drugs for treating B-cell non-Hodgkin's lymphoma.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Similar Trials

1
R/R DLBCL
1
Mosunetuzumab
1
RO7227166

Study Objectives

3 Primary · 21 Secondary · Reporting Duration: Until 90 days after the final dose of study treatment

Day 90
Percentage of participants with adverse events [dose escalation]
Percentage of participants with adverse events [dose expansion]
Percentage of participants with dose-limiting toxicities (DLTs) [dose escalation]
Day 28
CL of CELMoDs [all cohorts]
Cmax of CC-220 and CC-99282 (CELMoDs) [all cohorts]
Cmin of CELMoDs [all cohorts]
Volume of distribution of CELMoDs [all cohorts]
Year 2
AUC of glofitamab IV [all cohorts]
Apparent clearance (CL) of mosunetuzumab SC [all cohorts]
Apparent volume of distribution of mosunetuzumab SC [all cohorts]
Best CR rate, defined as the proportion of participants whose best overall response is a CR during the study, as determined by the investigator using Lugano 2014 criteria [all cohorts]
Best ORR (CR or PR at any time) on study as determined by the investigator using Lugano 2014 criteria [dose escalation]
Best overall response rate (ORR), defined as the proportion of participants whose best overall response is a partial response (PR) or a complete response (CR) during the study, as determined by the investigator using Lugano 2014 criteria [dose expansion]
CL of glofitamab IV [all cohorts]
Cmax of intravenous (IV) glofitamab [all cohorts]
Cmin of glofitamab IV [all cohorts]
Duration of response (DOR) as determined by the investigator using Lugano 2014 criteria [all cohorts]
Event-free survival (EFS) as determined by the investigator using Lugano 2014 criteria [dose expansion]
Maximum serum concentration (Cmax) of subcutaneous (SC) mosunetuzumab [all cohorts]
Minimum serum concentration (Cmin) of mosunetuzumab SC [all cohorts]
Overall survival (OS) [dose expansion]
Progression-free survival (PFS) as determined by the investigator using Lugano 2014 criteria [dose expansion]
Total exposure (AUC) of mosunetuzumab SC [all cohorts]
Volume of distribution of glofitamab IV [all cohorts]

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
R/R DLBCL
1
Mosunetuzumab
1
RO7227166

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Arm 1
1 of 2
Arm 2
1 of 2

Experimental Treatment

112 Total Participants · 2 Treatment Groups

Primary Treatment: Arm 1 · No Placebo Group · Phase 1

Arm 1Experimental Group · 4 Interventions: CC-99282, SC Mosunetuzumab, CC-220, Tocilizumab · Intervention Types: Drug, Drug, Drug, Drug
Arm 2Experimental Group · 5 Interventions: CC-99282, IV Glofitamab, CC-220, Tocilizumab, Obinutuzumab · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-99282
2017
Completed Phase 2
~70
CC-220
Not yet FDA approved
Tocilizumab
FDA approved
Obinutuzumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: until 90 days after the final dose of study treatment

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,388 Previous Clinical Trials
1,073,109 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,169 Previous Clinical Trials
880,963 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Are patients at risk of any adverse outcomes when participating in Arm 1?

"Arm 1 was assigned a score of 1, as this is an early-stage trial with limited data concerning both safety and efficacy." - Anonymous Online Contributor

Unverified Answer

Are there currently opportunities to participate in this scientific investigation?

"According to clinicaltrials.gov, this study is actively seeking participants for the trial which was posted on October 26th 2022 and modified on December 20th 2022." - Anonymous Online Contributor

Unverified Answer

Has Arm 1 been a subject of any past research initiatives?

"At present, 170 studies are underway that analyze Arm 1. Of these live trials, 27 have reached the third stage of clinical testing. The majority of investigations into this drug take place in Poznan and New York; however, 6752 different sites are conducting research on this intervention." - Anonymous Online Contributor

Unverified Answer

What therapeutic applications are typically associated with Arm 1?

"Arm 1 is typically prescribed to treat polyarticular juvenile idiopathic arthritis, but has also been used with success on conditions like refractory follicular lymphoma, rheumatoid arthritis, and cytokine release syndrome resulting from CAR-T cell therapy." - Anonymous Online Contributor

Unverified Answer

How many individuals are taking part in the present research trial?

"Affirmative. According to the listings on clinicaltrials.gov, this medical experiment was first posted on October 26th 2022 and has been in need of participants since then. The trial is seeking 112 individuals at 1 centre for recruitment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top