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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 2023 Phase 1 & 2 trial • 117 Patients • NCT03677141

58%

Cytokine release syndrome

45%

Nausea

37%

Neutropenia

32%

Diarrhoea

32%

Fatigue

29%

Neutrophil count decreased

29%

Decreased appetite

26%

Alanine aminotransferase increased

24%

Anaemia

24%

Vomiting

24%

Infusion related reaction

18%

Alopecia

16%

Aspartate aminotransferase increased

16%

White blood cell count decreased

16%

Dizziness

16%

Dyspepsia

16%

Thrombocytopenia

16%

Abdominal pain

16%

Rash

16%

Constipation

13%

Back pain

13%

Febrile neutropenia

13%

Peripheral sensory neuropathy

13%

Oedema peripheral

11%

Platelet count decreased

11%

Weight decreased

11%

Pruritus

11%

Hypophosphataemia

11%

Dyspnoea

11%

Pyrexia

11%

Hypokalaemia

11%

Hypomagnesaemia

Infection

Hyponatraemia

Lymphopenia

Urinary tract infection

Stomatitis

Neuropathy peripheral

Tachycardia

Asthenia

Dehydration

Hyperglycaemia

Dysgeusia

Paraesthesia

Dysuria

Pollakiuria

Hypertension

Hypotension

Headache

Gamma-glutamyltransferase increased

Hyperuricaemia

Arthralgia

Rhinorrhoea

Death

Herpes zoster

Leukocytosis

Vertigo

Rash maculo-papular

Liver function test increased

Hypoalbuminaemia

Vision blurred

Gastrooesophageal reflux disease

Insomnia

Diverticulum intestinal haemorrhagic

Hypertransaminasaemia

Cytomegalovirus infection reactivation

Syncope

Atrial fibrillation

Atrial flutter

Blood alkaline phosphatase increased

Blood bilirubin increased

Blood lactate dehydrogenase increased

Vitamin D deficiency

Muscular weakness

Myalgia

Pain in extremity

Restlessness

Urinary incontinence

Cardiac failure

Coma

Acute kidney injury

Acute pulmonary oedema

Dry skin

Nail disorder

Hepatic encephalopathy

Hyperhidrosis

Angina unstable

Neutropenic colitis

Mucosal inflammation

COVID-19

Gastroenteritis norovirus

Klebsiella infection

Troponin I increased

Hypocalcaemia

Cerebrovascular accident

Pneumonitis

Pulmonary haemorrhage

Chest discomfort

Urticaria

Chills

Pain

Blood creatinine increased

International normalised ratio increased

Lymphocyte count decreased

Hypoaesthesia

Tremor

Respiratory failure

Taste disorder

Ulcer

Anastomotic ulcer

Fistula

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)

Group A1: Phase Ib Mosunetuzumab + CHOP

Group A2: Phase Ib Mosunetuzumab + CHOP

Group B: Phase Ib Mosunetuzumab + CHP-Pola

Group C: Phase II Mosunetuzumab + CHOP

Arm 2: Phase II Rituximab + CHP-Pola (Randomized)

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

Positron Emission Tomography

2011

Completed Phase 2

~2200

Biospecimen Collection

2004

Completed Phase 3

~2030