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Monoclonal Antibodies
Mosunetuzumab +/− Polatuzumab Vedotin and Obinutuzumab for Lymphoma
Phase 2
Recruiting
Led By Ryan Lynch, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bulky disease (one site at least 7 cm or at least four sites of 3 cm)
Follicular lymphoma (grade 1-2 or 3a)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat patients with lymphoma.
Who is the study for?
Adults with untreated indolent B-cell non-Hodgkin lymphoma who have symptoms like pain, organ enlargement, or low blood counts due to the disease. They must be able to perform daily activities (0-2 on ECOG scale), have adequate organ function, and agree to use effective contraception. Excluded are pregnant women, those with certain infections or autoimmune diseases, recent monoclonal antibody treatment, uncontrolled illnesses, or a history of other cancers.Check my eligibility
What is being tested?
The trial is testing mosunetuzumab alone or combined with polatuzumab vedotin and obinutuzumab in patients. These drugs are types of targeted therapy that may block cancer growth by binding to specific proteins on cancer cells; one also delivers chemotherapy directly to the cell.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, fever and chills from immune response activation. There's also a risk of nerve damage (neuropathy) due to the chemotherapy component in polatuzumab vedotin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a large tumor or multiple tumors.
Select...
My condition is follicular lymphoma, grade 1-2 or 3a.
Select...
I have been diagnosed with a slow-growing type of non-Hodgkin lymphoma and have not received any treatment for it.
Select...
I am 18 years old or older.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have been diagnosed with a slow-growing type of non-Hodgkin lymphoma and have not received any systemic therapy.
Select...
I experience symptoms like pain or discomfort from my condition.
Select...
I have a cancerous node or area that is visible and measurable on scans.
Select...
My vital organs are at risk of failing.
Select...
My kidney function, measured by creatinine clearance, is adequate.
Select...
My spleen is enlarged.
Select...
I have an enlarged liver.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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)
Secondary outcome measures
Overall response rate (ORR)
Side 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: Treatment (mosunetuzumab, obinutuzumab, polatuzumab vedotin)Experimental Treatment3 Interventions
PART A: Patients receive mosunetuzumab SC over 30 seconds-2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity.
PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab IV on day 1 of cycle 9 and day 1 of subsequent cycles and polatuzumab vedotin IV on day 1. Treatment repeats every 21 day for 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Mosunetuzumab
2019
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,724 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,101 Total Patients Enrolled
Ryan Lynch, MDPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had another type of cancer that could affect the study or make it difficult to understand the results, unless the principal investigator approves it.I have a large tumor or multiple tumors.My condition is follicular lymphoma, grade 1-2 or 3a.I have been diagnosed with a slow-growing type of non-Hodgkin lymphoma and have not received any treatment for it.I am able to get out of my bed or chair and move around.I have had a solid organ transplant.I haven't taken corticosteroids for any condition in the last 14 days.My HIV is not under control.My lymphoma type is recognized by WHO and may have not responded to initial treatments.My cancer has spread to my brain or spinal cord.My blood clotting time is normal or managed if I'm on blood thinners.I have had treatment for lymphoma, but not including corticosteroids.I do not have severe nerve damage or a specific genetic nerve disorder.I am 18 years old or older.I have been diagnosed with a slow-growing type of non-Hodgkin lymphoma and have not received any systemic therapy.I haven't had monoclonal antibody treatment, investigational therapy, or live vaccines in the last 3 months.I experience symptoms like pain or discomfort from my condition.I need treatment because my symptoms are getting worse or affecting my organs.I have a cancerous node or area that is visible and measurable on scans.My hemoglobin level is at least 8 g/dL, and I haven't had a blood transfusion in the last 14 days.I agree to use effective birth control during and after treatment.I agree to use contraception or abstain from sex, and not donate sperm for 5 months after treatment.I do not have severe heart or lung diseases that could interfere with the study.I am not taking drugs that affect CYP3A4 or can stop them before starting Part B.I have a history of HLH or MAS.My blood clotting time is normal or managed with medication.My vital organs are at risk of failing.My kidney function, measured by creatinine clearance, is adequate.I have marginal zone lymphoma that didn't respond to antibiotics.I have not had major surgery in the last 4 weeks.My condition is getting steadily worse.My white blood cell count is healthy, unless due to lymphoma.My spleen is enlarged.I am currently being treated for a serious infection.I have had progressive multifocal leukoencephalopathy in the past.You have low blood cell counts, including white blood cells, red blood cells, or platelets, that are getting worse over time.I have an enlarged liver.I have a long-term active Epstein-Barr virus infection.You have a history of an autoimmune disease.I have no allergies to the drugs used in this treatment or to murine products.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (mosunetuzumab, obinutuzumab, polatuzumab vedotin)
Awards:
This trial has 1 awards, including:- 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.
Are there any negative consequences associated with Mosunetuzumab?
"While there is some data supporting Mosunetuzumab's safety, it only received a 2 because there are no studies that support its efficacy."
Answered by AI
Are there any other clinical trials that have utilized Mosunetuzumab?
"As of right now, there are a total of 142 ongoing studies related to Mosunetuzumab. 27 of these investigations are classified as Phase 3 trials. The majority of these studies originate in Detroit, Michigan; however, there are 7658 locations worldwide where research is being conducted."
Answered by AI
What are the main conditions that Mosunetuzumab is prescribed for?
"Mosunetuzumab is most commonly given to patients with kidney conditions. However, it has also shown efficacy in treating other diseases like heart transplantation, refractory follicular lymphoma, and therapeutic procedure."
Answered by AI
How many people are currently signed up to participate in this research?
"Yes, the information available on clinicaltrials.gov demonstrates that this trial is still seeking patients. The original posting date was March 23rd, 2022 and the most recent update was September 26th, of the same year. Only 42 people are needed for this study which will take place at a single site."
Answered by AI
Are new participants being recruited for this clinical trial?
"According to the website clinicaltrials.gov, this particular trial is still looking for individuals who want to participate. The original posting date was March 23rd, 2022 and it was most recently edited on September 26th, 2022."
Answered by AI
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