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Active not recruitingPHASE1INTERVENTIONAL

Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies

This study is looking into a new medicine called sonrotoclax, which belongs to a group of drugs known as Bcl-2 inhibitors. We're testing it in people who have been diagnosed with certain types of blood cancers, specifically mature B-cell malignancies like various lymphomas (such as follicular lymphoma and mantle cell lymphoma) and chronic lymphocytic leukaemia (CLL). The main goals are to find out if sonrotoclax is safe, how well people tolerate it, and to figure out the best dose to give. We're testing it both as a single treatment and in combination with other medicines called zanubrutinib and obinutuzumab. This research aims to understand how to use sonrotoclax most effectively for these conditions.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
BeOne Medicines
Enrolment target
437
Start
24 Mar 2020
Estimated completion
31 May 2027

What is this study about?

This study is exploring a new medicine called sonrotoclax. It's designed for people who have certain types of blood cancer, which doctors refer to as 'mature B-cell malignancies'. These are a group of cancers that affect specific white blood cells, including different kinds of lymphoma (like follicular lymphoma, diffuse large B-cell lymphoma, and mantle cell lymphoma) and chronic lymphocytic leukaemia (CLL).

The main reasons for doing this study are to see if sonrotoclax is safe for people to take, how well their bodies handle it, and to work out the best amount, or 'dose', of the medicine to give. We're testing sonrotoclax by itself, and also when it's given alongside two other approved medicines called zanubrutinib and obinutuzumab. This helps us understand if the new medicine works better when combined with existing treatments.

Finding the right dose is really important. We want to find a dose that is strong enough to have an effect but also has side effects that people can manage. This study will help doctors learn how to use sonrotoclax safely and effectively to potentially help patients with these blood cancers in the future.

Key takeaways

  • This study is for adults with certain types of blood cancers, including various lymphomas and leukaemia.
  • It's testing a new medicine called sonrotoclax, both alone and with other treatments.
  • The main goals are to check safety, how well it's tolerated, and to find the best dose.
  • Participation involves regular clinic visits, blood tests, and scans.
  • You might gain access to a new treatment, but there are also potential unknown side effects.
  • You can stop participating in the study at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with certain types of blood cancer. This includes specific lymphomas such as extranodal, splenic, or nodal Marginal Zone Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, or Mantle Cell Lymphoma. We are also looking for people with Chronic Lymphocytic Leukaemia (CLL) or Waldenström's Macroglobulinemia.

Crucially, your cancer must either have come back after previous treatment, or not responded well to earlier treatments. For some types of lymphoma, it must also be a form that has become more aggressive or for which an autologous stem cell transplant isn't suitable. You must also have active disease that your doctor believes needs treating and for which there is enough disease size that can be measured.

Your medical team will carefully check your specific diagnosis and medical history against a full list of criteria to see if this study could be a suitable option for you. Not everyone with these conditions will be able to join, as there are often detailed reasons why a particular study might not be the best fit for an individual patient.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult aged 18 or older?
  2. Have you been diagnosed with a specific blood cancer like lymphoma (e.g., Follicular Lymphoma, DLBCL, Mantle Cell Lymphoma) or Chronic Lymphocytic Leukaemia (CLL)?
  3. Has your cancer come back after previous treatment, or has it not responded to earlier treatments?
  4. Does your doctor believe your cancer needs active treatment at this time?
  5. Do you have measurable disease that doctors can track with scans?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be given the study medicine, sonrotoclax, which could be on its own or with zanubrutinib and obinutuzumab. You will have regular visits to the clinic for check-ups, where doctors and nurses will monitor your health, check for any side effects, and see how the treatment is affecting your cancer. These visits will involve physical exams, blood tests, and scans (like CT scans) to measure your disease. The total duration of your participation will depend on how you respond to the treatment, but these types of studies typically involve an initial period of treatment, followed by regular follow-up for a longer time.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new medicine before it's widely available, which could potentially help your condition. However, it's also important to be aware of potential risks, as sonrotoclax is a new medicine and may cause side effects that are not yet fully known or understood. Your doctor will discuss all known and potential risks with you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (43)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • UCLA Hematologyoncology
    Verified postcode
    Los Angeles, United States
  • Northwestern University
    Verified postcode
    Chicago, United States
  • University of Kansas Medical Center Research Institute
    Verified postcode
    Kansas City, United States
  • Massachusetts General Hospital
    Verified postcode
    Boston, United States
  • Mayo Clinic Rochester
    Verified postcode
    Rochester, United States
  • University of Nebraska Medical Center
    Verified postcode
    Omaha, United States
  • John Theurer Cancer Center Hackensack University Medical Center
    Verified postcode
    Hackensack, United States
  • Columbia University Medical Center
    Verified postcode
    New York, United States
  • Memorial Sloan Kettering Cancer Center Mskcc
    Verified postcode
    New York, United States
  • The James Cancer Hospital and Solove Research Institute At Ohio State University
    Verified postcode
    Columbus, United States
  • Upmc Hillman Cancer Center(Univ of Pittsburgh)
    Verified postcode
    Pittsburgh, United States
  • Md Anderson Cancer Center
    Verified postcode
    Houston, United States

Common questions

What is a 'mature B-cell malignancy'?

This is a type of cancer that starts in certain white blood cells called B-cells. It includes conditions like various lymphomas and chronic lymphocytic leukaemia (CLL).

What does 'R/R' mean?

'R/R' stands for 'relapsed or refractory' – it means your cancer has either come back after treatment or didn't respond to previous treatments.

What is the purpose of testing different doses?

We test different doses to find the amount of medicine that is most effective against the cancer but also causes the fewest and most manageable side effects.

What are 'Bcl-2 inhibitors'?

Bcl-2 inhibitors are a type of medicine that targets a specific protein in cancer cells, aiming to help these cells die off.

Who is BeOne Medicines?

BeOne Medicines is the new official name for BeiGene, the company sponsoring this study.

How to find out more

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

Discussion

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