Your session is about to expire
← Back to Search
Monoclonal Antibodies
Mosunetuzumab + Polatuzumab Vedotin for Follicular Lymphoma
Phase 2
Recruiting
Led By Nancy L Bartlett, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of follicular lymphoma grade 1-3A, stage II-IV by Ann Arbor criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 6 years)
Awards & highlights
Study Summary
This trial will test how well the combination of mosunetuzumab and polatuzumab vedotin works in patients with untreated follicular lymphoma.
Who is the study for?
Adults diagnosed with untreated follicular lymphoma grades 1-3A, stages II-IV. Participants must have certain symptoms or tumor sizes, be in good physical condition (ECOG ≤2), and have adequate organ function. They should not have had prior treatments for this lymphoma or other recent immunotherapies, CNS diseases, severe allergies to monoclonal antibodies, active infections like hepatitis B/C or HIV, autoimmune diseases requiring treatment, or any serious medical conditions that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: Mosunetuzumab and Polatuzumab vedotin on patients who haven't been treated before for follicular lymphoma. Mosunetuzumab directs immune cells to attack cancerous cells while Polatuzumab delivers a drug directly to them.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, fever and chills during infusion. There may also be an increased risk of infection due to immune system suppression and possible liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of lymphoma that is not the most aggressive form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 6 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 6 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with complete response (CR) as best response
Secondary outcome measures
Duration of first complete response (CR)
Duration of first response of complete response (CR) or partial response (PR)
Frequencies and grades of treatment-emergent adverse events (TEAEs)
+13 moreSide effects data
From 2021 Phase 1 trial • 23 Patients • NCT0431360841%
Cytokine release syndrome
35%
Diarrhoea
35%
Hypomagnesaemia
35%
Pyrexia
35%
Neuropathy peripheral
35%
Anaemia
24%
Thrombocytopenia
24%
Hypophosphataemia
24%
Liver function test abnormal
24%
Nausea
24%
Neutropenia
24%
Fatigue
24%
Constipation
24%
Platelet count decreased
18%
Headache
18%
Sepsis
18%
Neutrophil count decreased
18%
Arthralgia
18%
Peripheral sensory neuropathy
18%
Hypokalaemia
18%
Oral candidiasis
18%
Weight decreased
18%
Lethargy
12%
Flushing
12%
Superficial vein thrombosis
12%
Paraesthesia
12%
Blood alkaline phosphatase increased
12%
Abdominal pain
12%
Dizziness
12%
Abdominal discomfort
12%
Colitis
12%
Vomiting
12%
Rectal haemorrhage
12%
Gastrooesophageal reflux disease
12%
Pain in extremity
12%
Infusion related reaction
12%
Alanine aminotransferase increased
12%
Cough
6%
Rash
6%
Upper respiratory tract infection
6%
Cytomegalovirus infection reactivation
6%
Thrombosis
6%
Rash maculo-papular
6%
Pain in jaw
6%
Orthostatic hypotension
6%
Squamous cell carcinoma
6%
Vision blurred
6%
Abdominal distension
6%
Abdominal tenderness
6%
Tumour lysis syndrome
6%
Back pain
6%
Hypocalcaemia
6%
Hypertension
6%
Cellulitis
6%
Neutropenic sepsis
6%
Transient ischaemic attack
6%
Chest pain
6%
Aspartate aminotransferase increased
6%
Blood creatinine increased
6%
Adenocarcinoma
6%
Oropharyngeal pain
6%
Groin pain
6%
Abdominal pain lower
6%
Anal haemorrhage
6%
Performance status decreased
6%
Hypogammaglobulinaemia
6%
Seasonal allergy
6%
Urinary tract infection
6%
Gamma-glutamyltransferase increased
6%
Hyperlipidaemia
6%
External ear cellulitis
6%
Decreased appetite
6%
Hyperglycaemia
6%
Epistaxis
6%
Depression
6%
Photosensitivity reaction
6%
Injury
6%
Wound infection
6%
Hypoalbuminaemia
6%
Dyspnoea exertional
6%
Intention tremor
6%
Throat irritation
6%
Vasospasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Glofit-GemOx
Arm B: Mosun-GemOx
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mosunetuzumab and Polatuzumab VedotinExperimental Treatment2 Interventions
Patients receive CD3xCD20 bispecific antibody mosunetuzumab administered subcutaneously in combination with CD79b directed ADC polatuzumab vedotin administered intravenously. Mosunetuzumab and polatuzumab vedotin are given in combination for 6 cycles. Mosunetuzumab is given on Days 1, 8, and 15 of cycle 1 and then Day 1 thereafter, and polatuzumab vedotin is given on Day 1. After 6 cycles, patients continue on mosunetuzumab alone for 2 additional cycles. Patients undergo scans at the end of cycle 8, and if those scans show a complete response, patients will stop any further treatment and will enter follow-up. Patients with a partial response or stable disease on scans at the end of cycle 8 may receive up to 9 additional cycles of mosunetuzumab in the absence of disease progression or unacceptable toxicity. All cycles are planned to be 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
FDA approved
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,109 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,936 Previous Clinical Trials
2,299,818 Total Patients Enrolled
Institute for Follicular LymphomaUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a type of lymphoma that is not the most aggressive form.
Research Study Groups:
This trial has the following groups:- Group 1: Mosunetuzumab and Polatuzumab Vedotin
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many guinea pigs are helping out with this experiment?
"Yes, the information on clinicaltrials.gov indicates that this trial is actively recruiting patients. The trial was first posted on October 24th 2022 and was last updated on November 14th 2022. The study is looking for 34 participants at 1 location."
Answered by AI
Has Mosunetuzumab received government sanctioning for public use?
"There is currently some data supporting Mosunetuzumab's safety, but none for efficacy. Therefore, it was given a score of 2."
Answered by AI
Are there still enrolling patients in this research project?
"This is an active clinical trial that was originally posted on October 24th, 2020. The most recent edit to the study's information was made on November 14th of the same year."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger