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Monoclonal Antibodies
Mosunetuzumab for Chronic Lymphocytic Leukemia
Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CLL requiring treatment according to the International Workshop on CLL (iwCLL) criteria (Hallek et al 2018)
Eastern Cooperative Oncology Group (ECOG) performance score (PS) of ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first occurrence of a documented objective response to disease progression by iwcll 2018 criteria or death from any cause (up to approximately 12 months (arms a and b) or 24 months (arm c))
Awards & highlights
Study Summary
This trial will study a new drug for people with CLL that has come back or is not responding to treatment. They will look at how well the drug is tolerated and how it works in the body.
Who is the study for?
This trial is for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) who need treatment. They should have adequate bone marrow function, an ECOG score of ≤2, agree to use effective contraception, and have a life expectancy over 6 months. Exclusions include severe allergies to monoclonal antibodies, recent infections requiring IV antibiotics or hospitalization, pregnancy, prior specific cancer treatments within certain time frames.Check my eligibility
What is being tested?
The study tests mosunetuzumab alone and in combination with venetoclax in CLL patients. It evaluates safety and initial effectiveness while allowing some participants to continue their current BTK inhibitor therapy during the first part of the trial. The pharmacokinetics—or how the body processes these drugs—is also being studied.See study design
What are the potential side effects?
Potential side effects may include allergic reactions related to antibody treatment such as infusion reactions, liver issues due to tocilizumab contraindications (if applicable), and other common chemotherapy-related side effects like fatigue, nausea, blood disorders that could increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My CLL condition requires treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the first occurrence of a documented objective response to disease progression by iwcll 2018 criteria or death from any cause (up to approximately 12 months (arms a and b) or 24 months (arm c))
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first occurrence of a documented objective response to disease progression by iwcll 2018 criteria or death from any cause (up to approximately 12 months (arms a and b) or 24 months (arm c))
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Complete Response (CR) Rate
Duration of Response (DOR)
Event-Free Survival (EFS)
+9 moreSide 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
3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment3 Interventions
Participants with R/R CLL who have failed two prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab SC with venetoclax
Group II: Arm BExperimental Treatment2 Interventions
Participants with R/R CLL who have failed two prior lines of therapy, who are currently progressing on BTKi therapy, and who require salvage therapy as assessed by their treating physician will receive mosunetuzumab SC with BTKi overlap therapy for the first two cycles of mosunetuzumab SC
Group III: Arm AExperimental Treatment2 Interventions
Participants with R/R CLL who have failed two prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab subcutaneous (SC) monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Mosunetuzumab
2019
Completed Phase 2
~140
Tocilizumab
2012
Completed Phase 4
~1840
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,931 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,803 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been on a BTK inhibitor for 12+ months, my disease progressed on it, and I need more treatment.My liver works well, unless its issues are caused by my CLL.I have not received a live vaccine within the last 4 weeks and won't need one during or within 5 months after the study.I have not had major surgery in the last 4 weeks.I have had cancer before, but it meets the study's exceptions.I do not have any other major health issues that could interfere with the study.My CLL condition requires treatment.I agree to follow the study's rules about sex and not donating sperm.I can take care of myself but might not be able to do heavy physical work.I cannot take tocilizumab due to health reasons.My bone marrow functions well without needing extra help.I haven't had certain cancer treatments recently before starting the study treatment.I have not received treatments like mosunetuzumab or had an allogenic stem cell transplant before joining the study.My CLL has transformed into an aggressive form of non-Hodgkin's lymphoma.I haven't had any serious infections or been hospitalized for infections in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C
- Group 2: Arm A
- Group 3: Arm B
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.
How does Mosunetuzumab help patients the most?
"Mosunetuzumab is used to treat conditions like polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis (sjia), and giant cells. Additionally, this medication can help patients that develop cytokine release syndrome as a result of car-t cell therapy."
Answered by AI
Are there any Mosunetuzumab side effects that patients should be aware of?
"Because this is an early-stage trial, there is limited data to support the safety or efficacy of Mosunetuzumab."
Answered by AI
Are there any vacancies in this clinical trial for potential participants?
"This study is still recruiting patients, with the last update on clinicaltrials.gov being from October 27th, 2022. The trial was first posted online on March 7th, 2020."
Answered by AI
Is there precedent for Mosunetuzumab's use in medical research?
"As of the current moment, 77 studies are being conducted to research Mosunetuzumab. Of these, 9 are clinical trials in Phase 3. Many of the studies for Mosunetuzumab take place in Poznan and New york; however, 1666 locations worldwide are running trials for this medication."
Answered by AI
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