RecruitingPHASE1INTERVENTIONAL

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

This research study is investigating a new medication called mosunetuzumab (also known as Lunsumio) for people living with chronic lymphocytic leukaemia (CLL). This is a type of cancer that affects white blood cells. The study is for those whose CLL has either come back after treatment or hasn't responded to previous treatments. Researchers want to understand if mosunetuzumab is safe, how well it works, and how your body processes it. Sometimes, it will be given on its own, and in some cases, it will be combined with another drug called venetoclax. The study also allows certain participants who are already taking another type of CLL medication (BTKi) to continue it during the initial part of the study.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Hoffmann-La Roche

Enrolment target

137

Start

07 Mar 2022

Estimated completion

10 Feb 2032

Chronic Lymphocytic Leukemia

What is this study about?

This study is an important step in finding new ways to treat chronic lymphocytic leukaemia (CLL). CLL is a type of cancer that affects certain white blood cells in your body. Sometimes, after initial treatments, CLL can come back or stop responding to the medicines. This study focuses on people in that situation, looking for effective new options.

The main treatment being tested is called mosunetuzumab. We want to find out how safe and tolerable it is for patients, meaning how well people can take the drug and what side effects they might experience. We also want to see how effective it is in controlling or shrinking the cancer. Another important part is understanding how your body handles the drug – how it absorbs, distributes, metabolises, and gets rid of it. In some parts of the study, especially for those outside the US, mosunetuzumab will be given alongside another medication called venetoclax to see if combining them works better.

For some participants who are currently taking another CLL medicine called a BTKi and whose disease is progressing, the study allows them to continue their BTKi for the first couple of cycles of mosunetuzumab. This helps bridge their care while doctors assess their progress on the new study medication. Finding effective and safe treatments for CLL, especially for those whose disease has been challenging to manage, is crucial, and this study aims to contribute to that goal.

Key takeaways

This study tests a new treatment, mosunetuzumab, for CLL that has returned or not responded to previous treatments.
It aims to find out if mosunetuzumab is safe and effective.
Some participants might receive mosunetuzumab with another drug, venetoclax.
People already on specific CLL medication (BTKi) might be able to continue it during the initial study period.
The study involves regular check-ups, blood tests, and monitoring.

Who may be eligible?

To join this study, you must be 18 years or older and have been diagnosed with chronic lymphocytic leukaemia (CLL) that needs treatment. Your general health should be good enough to take part, meaning you can mostly go about your daily activities, and your liver and bone marrow (where blood cells are made) should be working reasonably well, unless your CLL is affecting them directly.

There are also specific rules about who can join certain parts of the study. For example, if you're taking another CLL medicine called a BTKi and it's no longer working, you might be able to continue it during the start of this study. If you live outside the US, you might be able to join a part of the study that tests mosunetuzumab alongside another drug, venetoclax.

You cannot join if you are pregnant or breastfeeding, or plan to become pregnant. You also can't join if you've already had treatment with mosunetuzumab or similar drugs. Good contraception is required for both men and women during and after the study if there's a chance of pregnancy.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of chronic lymphocytic leukaemia (CLL) that needs treatment?
Is your CLL no longer responding to previous treatments, or has it come back?
Are you able to go about your daily activities reasonably well?
Are you not currently pregnant or breastfeeding, and not planning to be during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive either mosunetuzumab alone or mosunetuzumab combined with venetoclax, depending on which part of the study you are in. You’ll have regular visits to the clinic for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. The study also looks at how your body processes the medicine.

For some people, if you are already taking a different medication for CLL (called a BTKi) and your CLL is getting worse, you might be able to continue taking your BTKi for the first couple of cycles of the study. You will have a follow-up period after your treatment finishes to ensure your health is still monitored. The total duration of your participation will depend on your individual response and how long your doctor believes it is beneficial for you to receive treatment, plus the follow-up period.

Potential risks and benefits

Taking part in a clinical trial means you might be among the first to receive a new treatment that could potentially help manage your CLL. However, like all medicines, mosunetuzumab and venetoclax can have side effects, and it's possible the treatment might not work for you. The study team will carefully monitor you for any side effects throughout your participation. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (31)

Mayo Clinic Rochester
Rochester, United States· Recruiting
Memorial Sloan-Kettering Cancer Center
New York, United States· Withdrawn
The James Cancer Hospital and Solove Research Institute
Columbus, United States· Recruiting
Uni of Texas - Md Anderson Cancer Center
Houston, United States· Withdrawn
Huntsman Cancer Institute at The University of Utah
Salt Lake City, United States· Recruiting
Princess Alexandra Hospital Woolloongabba
Woolloongabba, Australia· Recruiting
Peter MacCallum Cancer Center
East Melbourne, Australia· Completed
Monash Medical Centre
Melbourne, Australia· Recruiting
Peking University People's Hospital
Beijing, China· Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, China· Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, China· Recruiting
Tianjin Institute of Hematology & Blood Diseases Hospital
Tianjin, China· Recruiting

+19 more sites — see the official record for the full list.

Common questions

What is chronic lymphocytic leukaemia (CLL)?

CLL is a type of cancer that involves certain white blood cells. It often grows slowly, but sometimes it needs treatment.

What does 'relapsed or refractory' mean?

It means your CLL has either come back after previous treatment or hasn't responded well to treatments you've tried before.

What is mosunetuzumab?

Mosunetuzumab is a new medicine being tested. It's designed to help your immune system fight the cancer cells.

Can I continue my current CLL medication if I join?

If you're on a specific type of medication called a BTKi and your CLL is progressing, you might be able to continue it for the first few cycles of this study.

Are there different groups in this study?

Yes, some people will get mosunetuzumab alone, and others, mainly outside the US, will get it with another drug called venetoclax.

How to find out more

Reference Study ID Number: BO43243 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.