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Monoclonal Antibodies
Mosunetuzumab +/- Polatuzumab Vedotin for Diffuse Large B-Cell 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
At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest diameter
Histologically confirmed DLBCL according to World Health Organization (WHO) 2016 expected to express the cluster of differentiation-20 (CD20) antigen and one prior therapy with any systemic anthracycline-based chemoimmunotherapy containing regimen for previously untreated DLBCL with best response of SD or PR to prior systemic chemoimmunotherapy at the end of induction treatment in accordance with the Lugano 2014 criteria (for Cohort A)
Must not have
Clinically significant history of liver disease
Transformed lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new drug, mosunetuzumab, for safety and effectiveness in treating DLBCL, a type of lymphoma.
Who is the study for?
This trial is for adults with Diffuse Large B-Cell Lymphoma (DLBCL) who've had certain responses to first-line therapy or are elderly/unfit and untreated. Participants must have adequate organ function, an ECOG status of 0-2 (or improved to ≤2 if initially at 3), measurable lymphoma lesions, and no severe comorbidities. Exclusions include transformed lymphoma, prior transplants, significant liver disease or cardiovascular issues, CNS conditions including lymphoma, recent SARS-CoV-2 infection, history of HLH or PML, active viral infections like hepatitis B/C or HIV.
What is being tested?
The study tests mosunetuzumab as a follow-up treatment after initial chemoimmunotherapy in DLBCL patients with stable disease/partial response. It also examines mosunetuzumab alone or combined with polatuzumab vedotin in elderly/unfit patients without prior treatments. The drug's safety and effectiveness will be assessed through IV and subcutaneous administration methods.
What are the potential side effects?
Potential side effects may include reactions at the injection site for both IV and SC administrations; general symptoms like fatigue; possible changes in blood counts leading to increased infection risk; allergic reactions; potential impact on liver function; neurological effects such as peripheral neuropathy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be measured and is larger than 1.5 cm if it's in a lymph node or larger than 1.0 cm if it's not in a lymph node.
Select...
I have DLBCL, treated once with a specific chemo mix, and didn't fully recover.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a significant history of liver problems.
Select...
My lymphoma has changed into a more aggressive form.
Select...
I have been treated with mosunetuzumab before.
Select...
I have been diagnosed with progressive multifocal leukoencephalopathy.
Select...
I have or might have chronic Epstein Barr, hepatitis B, hepatitis C, or HIV.
Select...
I have had a solid organ transplant.
Select...
I have not had radiotherapy in the last 2 weeks.
Select...
I have a serious heart condition.
Select...
I have received chemotherapy, immunotherapy, and biologic therapy for DLBCL.
Select...
I do not have severe nerve damage or a specific nerve disease.
Select...
I have or had a brain-related condition like stroke or epilepsy.
Select...
I have had a stem cell transplant before.
Select...
My condition is CNS lymphoma.
Select...
I have or might have had HLH in the past.
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
Side effects data
From 2019 Phase 1 & 2 trial • 231 Patients • NCT0169189858%
Fatigue
46%
Neuropathy peripheral
42%
Diarrhoea
42%
Nausea
29%
Peripheral sensory neuropathy
29%
Decreased appetite
27%
Asthenia
25%
Neutropenia
25%
Cough
24%
Constipation
22%
Vomiting
20%
Pain in extremity
19%
Abdominal pain
19%
Arthralgia
19%
Dyspnoea
17%
Dizziness
17%
Anaemia
15%
Pyrexia
14%
Insomnia
14%
Hypokalaemia
14%
Dyspepsia
14%
Back pain
14%
Influenza like illness
14%
Oedema peripheral
14%
Headache
12%
Weight decreased
12%
Alopecia
10%
Chest pain
10%
Muscular weakness
10%
Pruritus
10%
Muscle spasms
10%
Hypomagnesaemia
10%
Bone pain
10%
Myalgia
8%
Peripheral motor neuropathy
8%
Dry mouth
8%
Musculoskeletal pain
8%
Anxiety
7%
Neutrophil count decreased
7%
Abdominal pain upper
7%
Chills
7%
White blood cell count decreased
7%
Hyperglycaemia
7%
Hyperhidrosis
7%
Night sweats
7%
Depression
5%
Dehydration
5%
Hypophosphataemia
5%
Dysuria
5%
Memory impairment
5%
Productive cough
5%
Taste Disorder
5%
Tachycardia
5%
Abdominal discomfort
5%
Gait disturbance
5%
Dysgeusia
5%
Hypertension
5%
Rash
3%
Thrombocytopenia
3%
Peripheral swelling
3%
Urinary tract infection
3%
Alanine aminotransferase increased
3%
Hypoaesthesia
3%
Febrile neutropenia
3%
Upper respiratory tract infection
3%
Vision blurred
3%
Abdominal distension
3%
Toothache
3%
Oral candidiasis
3%
Hyponatraemia
3%
Nasal congestion
3%
Dysphonia
3%
Acute kidney injury
3%
Malaise
3%
Fall
2%
Benign neoplasm of skin
2%
Skin Abrasion
2%
Paraesthesia
2%
Sinusitis
2%
Contusion
2%
Abdominal pain lower
2%
Gout
2%
Orthostatic hypotension
2%
Erythema
2%
Vertigo
2%
Haematoma
2%
Rash pruritic
2%
Hernial eventration
2%
General physical health deterioration
2%
Cholecystitis acute
2%
Pulmonary congestion
2%
Influenza
2%
Pharyngitis
2%
Groin pain
2%
Restless legs syndrome
2%
Syncope
2%
Tremor
2%
Rash erythematous
2%
Gastroenteritis viral
2%
Pancreatitis
2%
Rectal haemorrhage
2%
Subileus
2%
Axillary pain
2%
Hepatic steatosis
2%
Hepatocellular injury
2%
Hepatomegaly
2%
Bronchitis
2%
Clostridium difficile infection
2%
Febrile infection
2%
Lung disorder
2%
Hypotension
2%
Lymphadenopathy
2%
Ear discomfort
2%
Visual impairment
2%
Pain
2%
Oesophageal candidiasis
2%
Aspartate aminotransferase increased
2%
Blood creatinine increased
2%
Platelet count decreased
2%
Hypercalcaemia
2%
Hyperuricaemia
2%
Hypoxia
2%
Dermatitis acneiform
2%
Nasopharyngitis
2%
Infusion related reaction
2%
Epistaxis
2%
Chest discomfort
2%
Fistula of small intestine
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Cohort C (FL): RTX + Polatuzumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Elderly/Unfit Previously Untreated Monotherapy (Cohort B)Experimental Treatment2 Interventions
Elderly/unfit participants with previously untreated DLBCL will receive mosunetuzumab at the previously determined recommended phase II dose (RP2D).
Group II: Elderly/Unfit Previously Untreated Combination Therapy (Cohort C)Experimental Treatment3 Interventions
Elderly/unfit participants with previously untreated DLBCL will receive mosunetuzumab in combination with polatuzumab vedotin.
Group III: Consolidation Therapy (Cohort A)Experimental Treatment2 Interventions
Participants with a partial response to first-line chemotherapy will receive mosunetuzumab up to the recommended consolidation dose (RCD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Tocilizumab
2012
Completed Phase 4
~1840
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,102,939 Total Patients Enrolled
119 Trials studying Lymphoma
25,613 Patients Enrolled for Lymphoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
902,105 Total Patients Enrolled
96 Trials studying Lymphoma
23,849 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant history of liver problems.I have a tumor that can be measured and is larger than 1.5 cm if it's in a lymph node or larger than 1.0 cm if it's not in a lymph node.My blood counts are within a healthy range.I can care for myself and am under 80 if living in South Korea.My lymphoma has changed into a more aggressive form.I have been treated with mosunetuzumab before.I have been diagnosed with progressive multifocal leukoencephalopathy.I have or might have chronic Epstein Barr, hepatitis B, hepatitis C, or HIV.I have had a solid organ transplant.I have not had radiotherapy in the last 2 weeks.I have a serious heart condition.I had treatment for lymphoma more than 4 weeks ago.I have received chemotherapy, immunotherapy, and biologic therapy for DLBCL.I do not have severe nerve damage or a specific nerve disease.I am over 65 and have a specific type of lymphoma (DLBCL) that has not been treated.I have DLBCL, treated once with a specific chemo mix, and didn't fully recover.I have or had a brain-related condition like stroke or epilepsy.I have had a stem cell transplant before.My condition is CNS lymphoma.I have or might have had HLH in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Consolidation Therapy (Cohort A)
- Group 2: Elderly/Unfit Previously Untreated Monotherapy (Cohort B)
- Group 3: Elderly/Unfit Previously Untreated Combination Therapy (Cohort C)
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.