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NCT Number: NCT06943872

A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.

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Key information

About this study

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
  • Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy
  • Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
  • Adequate organ function

Exclusion criteria

  • Known active prolymphocytic leukemia or currently suspected Richter's transformation
  • Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
  • Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
  • Known central nervous system involvement by CLL/SLL
  • Severe or debilitating pulmonary disease
  • Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Sonrotoclax

Drug

Administered orally

Other names: BGB-11417

Obinutuzumab

Drug

Administered intravenously

Other names: Gazyva

Rituximab

Drug

Administered intravenously

Other names: Rituxan

Venetoclax

Drug

Administered Orally

Other names: Venclexta

Primary outcomes

  1. Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D

    Time frame: Up to approximately 51 months

    PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.

Secondary outcomes

  1. Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D

    Time frame: Up to approximately 69 months

    PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.

  2. Rate of uMRD4 for Arm A versus Arm D

    Time frame: Up to approximately 12 months

    The rate of undetectable minimal residual disease (uMRD4) in peripheral blood based on next-generation sequencing (NGS)

  3. Complete Response Rate as assessed by BIRC for Arm A versus Arm D

    Time frame: Up to approximately 25 months

    Complete Response Rate (CRR) is defined as the percentage of participants that achieve a best response of complete response (CR) or complete response with incomplete hematopoietic recovery (CRi)

  4. Overall Survival for Arm A versus Arm D

    Time frame: Up to approximately 84 months

    Overall survival (OS) is defined as the time from the date of randomization to the date of death

  5. PFS per Investigator Assessment (INV) for Arm B versus Arm D

    Time frame: Up to approximately 69 months

    PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.

  6. CRR per BIRC and by INV for Arm B versus Arm D

    Time frame: Up to approximately 25 months

    CRR is defined as the percentage of participants that achieve a best response of CR or CRi

  7. OS for Arm B versus Arm D

    Time frame: Up to approximately 84 months

    OS is defined as the time from the date of randomization to the date of death

  8. Rate of uMRD4 for Arm B versus Arm D

    Time frame: Up to approximately 25 months

    The rate of uMRD4 in peripheral blood based on NGS

  9. PFS per BIRC and by INV for Arm A versus Arm B

    Time frame: Up to approximately 69 months

    PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.

  10. CRR per BIRC and by INV for Arm A versus Arm B

    Time frame: Up to approximately 25 months

    CRR is defined as the percentage of participants that achieve a best response of CR or CRi

  11. OS for Arm A versus Arm B

    Time frame: Up to approximately 84 months

    OS is defined as the time from the date of randomization to the date of death

  12. Rate of uMRD4 for Arm A versus Arm B

    Time frame: Up to approximately 25 months

    The rate of uMRD4 in peripheral blood based on NGS

  13. Rate of uMRD4 for Arm A versus Arm D

    Time frame: Up to approximately 25 months

    The rate of uMRD4 in peripheral blood based on NGS

  14. CRR per INV for Arm A versus Arm D

    Time frame: Up to approximately 25 months

    CRR is defined as the percentage of participants that achieve a best response of CR or CRi

  15. PFS per INV for Arm A versus Arm D

    Time frame: Up to approximately 51 months

    PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.

  16. PFS per INV for Arm C versus Arm D

    Time frame: Up to approximately 69 months

    PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.

  17. CRR per INV for Arm C versus Arm D

    Time frame: Up to approximately 25 months

    CRR is defined as the percentage of participants that achieve a best response of CR or CRi

  18. OS for Arm C versus Arm D

    Time frame: Up to approximately 84 months

    OS is defined as the time from the date of randomization to the date of death

  19. Rate of uMRD4 for Arm C versus Arm D

    Time frame: Up to approximately 25 months

    The rate of uMRD4 in peripheral blood based on NGS

  20. Overall Response Rate (ORR) per BIRC and by INV

    Time frame: Up to approximately 25 months

    ORR is defined as the percentage of participants that achieve a best response of partial response (PR) or better

  21. Duration of Response (DOR) per BIRC and by INV

    Time frame: Up to approximately 69 months

    DOR is defined as the time from the date that response criteria were first met to the date of first documentation of disease progression or death, whichever occurs first

  22. Time to Response (TTR) per BIRC and by INV

    Time frame: Up to approximately 25 months

    TTR is defined as the time from the date of randomization to the date response criteria were first met

  23. Time to Next Anti-CLL/SLL Treatment (TTNT)

    Time frame: Up to approximately 84 months

    TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment

  24. Rate of uMRD4

    Time frame: Up to approximately 25 months

    The rate of uMRD4 in peripheral blood based on NGS

  25. Change from Baseline in the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Global Health Status/Quality of Life and Physical Functioning Scales

    Time frame: Baseline and up to approximately 69 months

    The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best). Higher scores in global health status (GHS) and functional scales indicate better health-related quality of life (HRQoL).

  26. Change from Baseline in EORTC QLQ for Chronic Lymphocytic Leukemia (EORTC QLQ-CLL17) Symptom Burden and Fatigue Scales

    Time frame: Baseline and up to approximately 69 months

    The EORTC QLQ-CLL17 is the CLL module of QLQ-C30 consisting of 17 items and comprising 3 scales: symptom burden due to disease and/or treatment (6 items), physical condition/fatigue (4 items), and worries/fears about health and functioning (7 items) Items are rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much") and the recall period for all items is the past 7 days. Lower scores indicate better HRQoL.

  27. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From the first dose of study drug(s) to 30 days after the last dose of sonrotoclax or venetoclax, or 90 days after the last dose of obinutuzumab or rituximab; up to approximately 26 months

    Number of participants with TEAEs, including laboratory values, vital signs, and physical examination findings, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

1-877-828-5568

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Collaborators

  • German CLL Study Group

Registry information

Official study title

A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Apr 24, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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