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New dosing strategy aims to reduce dangerous side effect in blood cancer treatment

NCT ID NCT06697184

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests new ways to give the drug sonrotoclax to adults with chronic lymphocytic leukemia or mantle cell lymphoma. The goal is to find a dosing schedule that lowers the risk of tumor lysis syndrome, a serious side effect. About 258 participants will be enrolled to check safety and tolerability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 258 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2. 2. Adequate organ function and no very recent transfusion or blood growth factor 3. Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later. Only for participants with Chronic Lymphocytic Leukemia (CLL): 4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease 5. At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation. Only for participants with Mantle cell lymphoma (MCL): 6. Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC). 7. Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation. 8. Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter. Exclusion Criteria: 1. Participants unable to comply with the requirements of the protocol 2. Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Positive HIV serology (HIVAb) status unless certain conditions are met. 4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment 5. Prior systemic treatment for the CLL 6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment 7. Prior exposure to a BCL-2 inhibitor NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia hematopoietic and lymphoid system neoplasm mantle cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia CLL Mantle cell lymphoma MCL

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Blacktown Cancer and Haematology Centre

    RECRUITING

    Blacktown, New South Wales, NSW 2148, Australia

  • Cabrini Hospital Malvern

    RECRUITING

    Malvern, Victoria, VIC 3144, Australia

  • Chu Dijon

    RECRUITING

    Dijon, 21000, France

  • Chu Montpellier Hopital Saint Eloi

    RECRUITING

    Montpellier, 34090, France

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215-5418, United States

  • Fort Wayne Medical Oncology and Hematology

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109-4433, United States

  • Genesiscare St Andrews

    RECRUITING

    Adelaide, South Australia, SA 5000, Australia

  • Iuct Oncopole

    RECRUITING

    Toulouse, 31100, France

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612-9496, United States

  • Queen Elizabeth Hospital

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Rockingham Hospital

    RECRUITING

    Cooloongup, Western Australia, WA 6168, Australia

  • St Jamess University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, VIC 3004, Australia

  • The University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205-2003, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

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