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Monoclonal Antibodies

Mosunetuzumab +/− Polatuzumab Vedotin and Obinutuzumab for Lymphoma

Phase 2

Waitlist Available

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)

Must not have

Prior solid organ transplantation

History of uncontrolled HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have a large tumor or multiple tumors.

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My condition is follicular lymphoma, grade 1-2 or 3a.

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I have been diagnosed with a slow-growing type of non-Hodgkin lymphoma and have not received any treatment for it.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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I have been diagnosed with a slow-growing type of non-Hodgkin lymphoma and have not received any systemic therapy.

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I experience symptoms like pain or discomfort from my condition.

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I have a cancerous node or area that is visible and measurable on scans.

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My vital organs are at risk of failing.

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My kidney function, measured by creatinine clearance, is adequate.

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My spleen is enlarged.

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I have an enlarged liver.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a solid organ transplant.

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My HIV is not under control.

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My cancer has spread to my brain or spinal cord.

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I have a history of HLH or MAS.

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I do not have severe nerve damage or a specific genetic nerve disorder.

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I haven't had monoclonal antibody treatment, investigational therapy, or live vaccines in the last 3 months.

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I do not have severe heart or lung diseases that could interfere with the study.

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I am currently being treated for a serious infection.

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I have had progressive multifocal leukoencephalopathy in the past.

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I have a long-term active Epstein-Barr virus infection.

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I have no allergies to the drugs used in this treatment or to murine products.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete response (CR)

Secondary study objectives

Overall response rate (ORR)

Side effects data

From 2021 Phase 1 trial • 23 Patients • NCT04313608

41%

Cytokine release syndrome

35%

Diarrhoea

35%

Anaemia

35%

Hypomagnesaemia

35%

Pyrexia

35%

Neuropathy peripheral

24%

Constipation

24%

Platelet count decreased

24%

Neutropenia

24%

Hypophosphataemia

24%

Nausea

24%

Liver function test abnormal

24%

Fatigue

24%

Thrombocytopenia

18%

Lethargy

18%

Hypokalaemia

18%

Arthralgia

18%

Weight decreased

18%

Neutrophil count decreased

18%

Oral candidiasis

18%

Sepsis

18%

Headache

18%

Peripheral sensory neuropathy

12%

Paraesthesia

12%

Vomiting

12%

Superficial vein thrombosis

12%

Rectal haemorrhage

12%

Flushing

12%

Cough

12%

Infusion related reaction

12%

Blood alkaline phosphatase increased

12%

Abdominal pain

12%

Pain in extremity

12%

Gastrooesophageal reflux disease

12%

Alanine aminotransferase increased

12%

Colitis

12%

Abdominal discomfort

12%

Dizziness

Hypocalcaemia

Rash

Performance status decreased

Decreased appetite

Chest pain

Cytomegalovirus infection reactivation

Hyperlipidaemia

Dyspnoea exertional

Vasospasm

Gamma-glutamyltransferase increased

Orthostatic hypotension

Cellulitis

Wound infection

Hypogammaglobulinaemia

Abdominal distension

External ear cellulitis

Tumour lysis syndrome

Upper respiratory tract infection

Back pain

Urinary tract infection

Transient ischaemic attack

Hypertension

Blood creatinine increased

Abdominal tenderness

Seasonal allergy

Injury

Hypoalbuminaemia

Epistaxis

Throat irritation

Hyperglycaemia

Oropharyngeal pain

Intention tremor

Adenocarcinoma

Thrombosis

Rash maculo-papular

Squamous cell carcinoma

Photosensitivity reaction

Depression

Neutropenic sepsis

Vision blurred

Abdominal pain lower

Anal haemorrhage

Aspartate aminotransferase increased

Groin pain

Pain in jaw

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Glofit-GemOx

Arm B: Mosun-GemOx

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (mosunetuzumab, obinutuzumab, polatuzumab vedotin)Experimental Treatment9 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. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab IV on day 1, 8, and 15 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. Patients also undergo CT, PET/CT, and FDG-PET scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Bone Marrow Aspiration

2011

Completed Phase 2

~1740