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Alkylating agents
Mosunetuzumab + Chemotherapy for B-Cell Lymphoma
Phase 1
Recruiting
Led By Nancy L Bartlett, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 48 months
Awards & highlights
Study Summary
This trial is testing whether adding mosunetuzumab to chemotherapy may help patients with aggressive B cell lymphoma who have relapsed or are unresponsive to other treatments.
Who is the study for?
This trial is for adults with certain aggressive B cell lymphomas that have come back or didn't respond to initial treatments. They should be planning an autologous stem cell transplant and must not have had more than two prior chemotherapy lines. Participants need normal blood counts, no major recent surgeries, and can't be pregnant or breastfeeding. Those with autoimmune diseases, a history of severe allergies to monoclonal antibodies, active infections, or liver disease are excluded.Check my eligibility
What is being tested?
The study tests mosunetuzumab combined with platinum-based salvage chemotherapy (DHAX or ICE) in patients aiming for stem cell transplantation. It's designed to see if this combination is safe and potentially better than current chemoimmunotherapy options that use rituximab retreatment.See study design
What are the potential side effects?
Mosunetuzumab may cause side effects like infusion reactions (symptoms during or after the drug is given), low blood counts leading to increased infection risk, tiredness, and potential organ inflammation. The exact side effects will vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequencies and grades of treatment-emergent adverse events (TEAEs)
Rate of treatment delay or discontinuation due to treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Number of participants with complete response (CR)
Number of participants with partial response (PR)
Number of participants with progressive disease (PD)
+6 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
2Treatment groups
Experimental Treatment
Group I: Arm B: Mosunetuzumab + ICEExperimental Treatment2 Interventions
3 cycles (cycle=21 days) of mosunetuzumab with ICE salvage chemotherapy (selected at the discretion of the treating physician).
The first 3 patients in each arm will receive Dose Level 1 along with standard dosing of ICE. The rate of dose-limiting toxicities will determine whether the subsequent 3 patients in each arm are enrolled at Dose Level 1, or alternatively at Dose Level -1.
For patients tolerating Cycle 1 of treatment, Cycles 2 and 3 will consist of mosunetuzumab administered as a single dose on Day 1 along with ICE. Patients will undergo PET-CT restaging prior to Cycle 3, and those achieving a CR (or PR, at their physician's discretion) will receive the Cycle 3 dose of mosunetuzumab and ICE, followed by standard of care stem cell mobilization and autoSCT. Patients with SD or PD after restaging will discontinue study treatment.
Group II: Arm A: Mosunetuzumab + DHAXExperimental Treatment2 Interventions
3 cycles (cycle=21 days) of mosunetuzumab with DHAX salvage chemotherapy (selected at the discretion of the treating physician).
The first 3 patients in each arm will receive Dose Level 1 along with standard dosing of DHAX. The rate of dose-limiting toxicities will determine whether the subsequent 3 patients in each arm are enrolled at Dose Level 1, or alternatively at Dose Level -1.
For patients tolerating Cycle 1 of treatment, Cycles 2 and 3 will consist of mosunetuzumab administered as a single dose on Day 1 along with DHAX. Patients will undergo PET-CT restaging prior to Cycle 3, and those achieving a CR (or PR, at their physician's discretion) will receive the Cycle 3 dose of mosunetuzumab and DHAX, followed by standard of care stem cell mobilization and autoSCT. Patients with SD or PD after restaging will discontinue study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ICE
2012
Completed Phase 2
~290
Mosunetuzumab
2019
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,889 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,767 Total Patients Enrolled
Nancy L Bartlett, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma has affected my central nervous system.I do not have any other cancer that could interfere with this study.I haven't had CAR-T cell therapy in the last 6 months.I have had a stem cell transplant before.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.I am allergic to certain biopharmaceuticals or ingredients in mosunetuzumab.I have a significant history of liver problems.I haven't taken any immune-weakening drugs in the last 2 weeks.I have an active hepatitis C infection.I haven't had major surgery in the last 28 days and don't expect any during the study.I haven't had radiotherapy in the last 2 weeks.I have never had progressive multifocal leukoencephalopathy.I have had a solid organ transplant.I have or might have a long-term active Epstein-Barr virus infection.I plan to have a stem cell transplant using my own cells after chemotherapy.I have not had a major infection or needed IV antibiotics in the last week.I've had severe skin reactions or blisters from past immune therapy.I am currently being treated for an autoimmune disease.My blood counts are within a normal range, not affected by lymphoma.Any major side effects from my previous treatments have mostly gone away.I've had side effects from previous immune therapy treatments.I do not have any major health issues that could interfere with the study.I've had 1 or 2 treatments with chemotherapy for lymphoma.I have a history of MAS or HLH.I haven't had a live vaccine in the last 4 weeks and don't plan to during the study.I have had a brain disease or condition in the last 6 months.My B cell lymphoma didn't respond to or has returned after specific chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Mosunetuzumab + ICE
- Group 2: Arm A: Mosunetuzumab + DHAX
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.
Has the regulatory body approved Mosunetuzumab for therapeutic use?
"Due to a lack of evidence, our team assesses Mosunetuzumab's safety as a '1' on the 1-3 scale. This is because it has only completed Phase 1 clinical trials and thus there is still limited data regarding its efficacy or security."
Answered by AI
Are participants still being welcomed to join this research endeavor?
"This particular clinical trial, which was posted on December 31st 2022 and last updated November 22nd 2022 is not currently recruiting patients. Nevertheless, 1825 other trials remain open to participants at this current juncture."
Answered by AI
What primary outcomes is this trial aiming to ascertain?
"According to Genentech, Inc., the primary outcome being measured over a 13 week period is the Rate of treatment delay or discontinuation due to adverse events. Furthermore, secondary outcomes such as Number of participants with Progressive Disease (PD), total doses of Tocilizumab for managing Cytokine Release Syndrome (CRS), and Number of Participants with Partial Response (PR) will also be evaluated."
Answered by AI
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