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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first study treatment to the first occurrence of disease progression, relapse, or death, whichever occurs first (up to approximately 2.5 years)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the first study treatment to the first occurrence of disease progression, relapse, or death, whichever occurs first (up to approximately 2.5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first study treatment to the first occurrence of disease progression, relapse, or death, whichever occurs first (up to approximately 2.5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PET-CT ORR at PRA According to the Lugano 2014 Criteria as Determined by an Independent Review Committee (IRC) (Cohort C)
PET-CT Objective Response Rate (ORR) at PRA According to Lugano 2014 Response Criteria as Determined by the Investigator (Cohort B)
Percentage of Participants with Adverse Events
+1 moreSecondary outcome measures
Anti-Drug Antibodies (ADAs) to Mosunetuzumab
Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin (Cohort C)
Area Under the Curve (AUC) of Mosunetuzumab IV
+29 moreSide effects data
From 2019 Phase 1 & 2 trial • 231 Patients • NCT0169189845%
Fatigue
35%
Constipation
33%
Diarrhoea
28%
Nausea
25%
Headache
20%
Neutropenia
20%
Vomiting
20%
Chills
20%
Neuropathy peripheral
18%
Pruritus
18%
Peripheral sensory neuropathy
18%
Infusion related reaction
18%
Decreased appetite
18%
Pain in extremity
18%
Cough
15%
Night sweats
15%
Dizziness
13%
Pyrexia
13%
Abdominal pain upper
13%
Dyspepsia
13%
Dyspnoea
10%
Abdominal pain
10%
Thrombocytopenia
10%
Dehydration
10%
Peripheral motor neuropathy
10%
Paraesthesia
10%
Nasal congestion
10%
Productive cough
10%
Flushing
10%
Anaemia
10%
Aspartate aminotransferase increased
10%
Arthralgia
8%
Fall
8%
Urinary tract infection
8%
Hyperuricaemia
8%
Asthenia
8%
Dry skin
8%
Erythema
8%
Dry eye
8%
Abdominal distension
8%
Alanine aminotransferase increased
8%
Dysgeusia
8%
Muscle spasms
8%
Restless legs syndrome
5%
Lipase increased
5%
Peripheral swelling
5%
Myalgia
5%
Vertigo
5%
Pneumonia
5%
Hypophosphataemia
5%
Oropharyngeal pain
5%
Nocturia
5%
Sinusitis
5%
Influenza
5%
Lymphadenopathy
5%
Tachycardia
5%
Vision blurred
5%
Visual impairment
5%
Dry mouth
5%
Gait disturbance
5%
Malaise
5%
Protein total decreased
5%
White blood cell count decreased
5%
Hypercalcaemia
5%
Back pain
5%
Musculoskeletal chest pain
5%
Hypoxia
5%
Alopecia
5%
Hypotension
5%
Dysphonia
5%
Tremor
5%
Anxiety
5%
Oedema peripheral
3%
Insomnia
3%
Tumour lysis syndrome
3%
Candida infection
3%
Herpes zoster
3%
Cellulitis
3%
Chest pain
3%
Upper respiratory tract infection
3%
Cholangitis
3%
Musculoskeletal discomfort
3%
Cognitive disorder
3%
Hypoaesthesia
3%
Depression
3%
Sinus congestion
3%
Skin Abrasion
3%
Taste Disorder
3%
Atrial fibrillation
3%
Abdominal pain lower
3%
Subdural Haematoma
3%
Abdominal discomfort
3%
Dysphagia
3%
Gastrooesophageal reflux disease
3%
Toothache
3%
Hypogammaglobulinaemia
3%
Blood creatinine increased
3%
Hyperglycaemia
3%
Hypomagnesaemia
3%
Muscle tightness
3%
Muscular weakness
3%
Hyperhidrosis
3%
Rash pruritic
3%
Rash
3%
Dyspnoea exertional
3%
Epistaxis
3%
Rhinorrhoea
3%
Influenza like illness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Cohort C (FL): RTX + Polatuzumab
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
2,432 Previous Clinical Trials
1,089,698 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,415 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Where are the sites of this clinical trial?
"Presently, this clinical trial is enrolling patients from 11 sites which are situated in Philadelphia, New york, Miami and 8 other locations. If you wish to take part in the study, it would be advantageous to select a site near your residence to limit travel."
Answered by AI
What are the main indications for Polatuzumab Vedotin?
"Polatuzumab vedotin is often used in therapeutic procedures. Additionally, it has shown to be effective the treatment of dlbcl, sjia, and cytokine release syndrome car-t cell therapy."
Answered by AI
Are there any similar studies to Polatuzumab Vedotin that have already been completed?
"Currently, there are a total of 92 clinical trials studying Polatuzumab Vedotin. Out of those, 12 have progressed to Phase 3 testing. Although the majority of these studies originated in Tbilisi and New york, 2206 medical centres worldwide are trialling this medication."
Answered by AI
Are investigators still looking for participants for this research project?
"That is correct, the public information available on clinicaltrials.gov does show that this research project is still enrolling patients. The 188 participants will be recruited from 11 hospitals or clinics across the country. This particular trial was first posted on May 23rd, 2019 and was most recently updated on November 8th, 2020."
Answered by AI
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