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M+P (Arm A) for Non-Hodgkin's Lymphoma

Tokai University Hospital, Kanagawa, Japan
Non-Hodgkin's LymphomaMosunetuzumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will compare the effectiveness of mosunetuzumab+polatuzumab vedotin to rituximab+gemcitabine+oxaliplatin in people with relapsed or refractory DLBCL, high-grade B-cell lymphoma, transformed follicular lymphoma, and FL3B.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Tocilizumab
1
Loncastuximab Tesirine
1
Mosunetuzumab (IV)

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: Up to 2 years

Year 2
Overall survival (OS)
Year 2
Progression-free survival (PFS)
Year 2
PFS
Year 2
Duration of complete response (DOCR)
Year 2
Duration of response (DOR)
Up to 2 years
Change from baseline in peripheral neuropathy as measured by the functional assessment of cancer therapy/gynecologic oncology group - neurotoxicity (FACT/GOG-NTX)
Change from baseline in the EuroQol 5-dimension, 5-level questionnaire (EuroQol EQ 5D-5L) index-based scores
Change from baseline in the EuroQol EQ 5D-5L visual analog scale (VAS) scores
Complete response rate (CRR)
Incidence of adverse events (AEs)
Incidence of anti-drug antibodies (ADAs) to mosunetuzumab
Incidence of anti-drug antibodies (ADAs) to polatuzumab vedotin
Objective response rate (ORR)
Plasma concentration of polatuzumab vedotin
Serum concentration of mosunetuzumab
Time to deterioration in lymphoma symptoms as measured by the functional assessment of cancer therapy lymphoma subscale (FACT-Lym LymS)
Time to deterioration in physical functioning and fatigue as measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Tocilizumab
1
Loncastuximab Tesirine
1
Mosunetuzumab (IV)

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

M+P (Arm A)
1 of 2
R-GemOx (Arm B)
1 of 2

Experimental Treatment

222 Total Participants · 2 Treatment Groups

Primary Treatment: M+P (Arm A) · No Placebo Group · Phase 3

M+P (Arm A)Experimental Group · 3 Interventions: Mosunetuzumab, Polatuzumab vedotin, Tocilizumab · Intervention Types: Drug, Drug, Drug
R-GemOx (Arm B)Experimental Group · 3 Interventions: Rituximab, Gemcitabine, Oxaliplatin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
Not yet FDA approved
Tocilizumab
FDA approved
Rituximab
FDA approved
Gemcitabine
FDA approved
Oxaliplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,388 Previous Clinical Trials
1,072,999 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,169 Previous Clinical Trials
880,853 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Is R-GemOx (Arm B) a new medication?

"As of right now, 1225 different clinical studies are running that involve R-GemOx (Arm B). 342 of those active studies are in Phase 3. The majority of studies for R-GemOx (Arm B) are based in Guangzhou, Guangdong; however, 52797 total locations across the globe are conducting these sorts of trials." - Anonymous Online Contributor

Unverified Answer

Does R-GemOx (Arm B) have FDA approval?

"R-GemOx (Arm B) has undergone Phase 3 clinical trials, meaning that there is available data supporting both its efficacy and safety. Our team at Power rates the safety of R-GemOx highly, with a score of 3." - Anonymous Online Contributor

Unverified Answer

What is the total size of the study's test group?

"That is correct. The clinicaltrial.gov website shows that this trial, which was originally posted on April 25th, 2022, is still recruiting patients. They are looking for 222 participants at 1 site." - Anonymous Online Contributor

Unverified Answer

What is the standard treatment that R-GemOx (Arm B) is used to manage?

"R-GemOx (Arm B) is the standard of care for diffuse large b-cell lymphoma (dlbcl). This treatment option is also effective for small cell lung cancer (sclc), systemic juvenile idiopathic arthritis (sjia), and head and neck carcinoma." - Anonymous Online Contributor

Unverified Answer

Is it possible to sign up for this research program at the present time?

"The clinical trial, which is currently seeking 222 patients from 1 site, was originally posted on 4/25/2022 and last edited on 11/1/2022 according to information found on clinicaltrials.gov" - 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.

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