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Anti-cancer agents

Polatuzumab Vedotin for Non-Hodgkin's Lymphoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through follow-up (up to approximately 2.5 years)
Awards & highlights

Study Summary

This trial will test the safety and efficacy of two different combinations of drugs for people with B-cell non-Hodgkin lymphoma who have either relapsed or are refractory to previous treatment, or who have not been treated before.

Eligible Conditions
  • Non-Hodgkin Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through follow-up (up to approximately 2.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through follow-up (up to approximately 2.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR) Rate at the Time of Primary Response Assessment Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Assessed According to Lugano 2014 Response Criteria
Percentage of Participants with Adverse Events (AE)
Secondary outcome measures
ADAs to Polatuzumab Vedotin
AUC of Polatuzumab Vedotin
Anti-Drug Antibodies (ADAs) to Mosunetuzumab
+16 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Phase Ib: Mosunetuzumab (M)-CHOP Dose FindingExperimental Treatment7 Interventions
Participants will receive M-CHOP up to the phase II recommended dose (RP2D).
Group II: Phase Ib: M-CHP-Pola Dose-FindingExperimental Treatment6 Interventions
Participants will receive M-CHP-Pola up to the RP2D.
Group III: Phase II: M-CHP-Pola 1L DLBCLExperimental Treatment6 Interventions
Participants with 1L DLBCL will receive M-CHP-Pola at a dose determined in the dose finding stage.
Group IV: Phase II: M-CHOP Previously Untreated (1L) DLBCL Safety CohortExperimental Treatment6 Interventions
Participants with 1L DLBCL will receive mosunetuzumab at the RP2D in combination with CHOP.
Group V: Phase II: M-CHOP 1L DLBCLExperimental Treatment6 Interventions
Participants with 1L DLBCL will receive M-CHOP at a dose determined in the dose finding stage.
Group VI: Phase II: Rituxumab (R)-CHP-Pola 1L DLBCLActive Control5 Interventions
Participants with 1L DLBCL will receive R-CHP-Pola at a dose determined in the dose finding stage.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Doxorubicin
2012
Completed Phase 3
~7940
Prednisone
2014
Completed Phase 4
~2370
Vincristine
2003
Completed Phase 4
~2910
Tocilizumab
2012
Completed Phase 4
~1840
Cyclophosphamide
1995
Completed Phase 3
~3770
Mosunetuzumab
2019
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,937 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,385 Total Patients Enrolled

Media Library

Cyclophosphamide (Anti-cancer agents) Clinical Trial Eligibility Overview. Trial Name: NCT03677141 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL, Phase Ib: M-CHP-Pola Dose-Finding, Phase II: M-CHOP 1L DLBCL, Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding, Phase II: M-CHOP Previously Untreated (1L) DLBCL Safety Cohort, Phase II: M-CHP-Pola 1L DLBCL
Non-Hodgkin's Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03677141 — Phase 1 & 2
Cyclophosphamide (Anti-cancer agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03677141 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the most common illnesses that Polatuzumab Vedotin helps patients with?

"Polatuzumab Vedotin is not only useful in the treatment of lung cancers, but also small cell lung cancer (sclc), thyroiditis, and neuroblastoma (nb)."

Answered by AI

How many people are currently included in this experiment?

"This specific trial is no longer recruiting patients, as the most recent update was on October 31st, 2022. However, there are 1810 other trials for lymphoma, b-cell and 1285 studies for Polatuzumab Vedotin that are still admitting patients."

Answered by AI

Are new participants still being sought for this experiment?

"This specific trial is not searching for new participants right now but there are plenty of other studies that might be a match. According to our records, this study was first posted on February 8th, 2019 and edited last on October 31st, 2022. There are 1810 trials related to lymphoma, b-cell currently recruiting and 1285 trials involving Polatuzumab Vedotin."

Answered by AI

How many different staff locations are necessary to manage this study?

"There are 15 sites enrolling patients in this trial. Major cities offering this medication include New york, Miami, and San Francisco."

Answered by AI

Are there any historical precedents for using Polatuzumab Vedotin?

"Polatuzumab vedotin was first investigated in 1997 at the Spectrum Health Hospital - Butterworth Campus. As of today, 2065 studies have completed while 1,285 are ongoing. The majority of these active trials are being conducted in Birmingham, Alabama."

Answered by AI

To your knowledge, are there other similar trials being conducted?

"Alfacell conducted the first study on Polatuzumab Vedotin in 1997 with 300 participants. After Phase 3 approval, there are currently 1285 studies being conducted in 2829 cities and 79 countries."

Answered by AI
~19 spots leftby Apr 2025