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NCT Number: NCT05479994

Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The purpose of this study is to evaluate the efficacy of BGB-11417 in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Relapsed Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria

  • Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria:
  • Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or
  • Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator.
  • Participants who require treatment based on the iwCLL 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
  • Life expectancy of > 6 month

Key Exclusion Criteria

  • Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or low risk (Gleason score ≤ 6) localized prostate cancer
  • Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results
  • A known history of or currently suspected Richter's syndrome
  • Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion)
  • Prior allogeneic stem cell transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

BGB-11417

Drug

Administered orally

Other names: sonrotoclax

Primary outcomes

  1. Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)

    Time frame: Up to 2 Years

    Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for partiticpants with small lymphocytic lymphoma (SLL)

Secondary outcomes

  1. Overall Response Rate (ORR) as assessed by the investigator

    Time frame: Up to 2 Years

    Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for participants with small lymphocytic lymphoma (SLL)

  2. Duration of response (DoR) as determined by the IRC and the investigator

    Time frame: Up to 5 Years

    DoR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first

  3. Progression Free Survival (PFS) as determined by the IRC and the investigator

    Time frame: Up to 5 Years

    PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first.

  4. Time to Response (TTR) as assessed by investigator and IRC

    Time frame: Up to 2 Years

    TTR is defined as the time from treatment initiation to the first documented response.

  5. Overall Survival (OS)

    Time frame: Up to 5 Years

    defined as time from the start of treatment to the date of death due to any cause

  6. Participants Reported Outcome as measured by EQ-5D-5L questionnaires

    Time frame: Up to 5 Years

    The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to).

  7. Participant Reported Outcomes as measured by NFLymSI-18

    Time frame: Up to 5 Years

    The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (NFLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.

  8. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 5 Years

    with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5 and the Grading Scale for Hematologic Toxicity in CLL Studies

  9. Number of participants with clinically significant changes from baseline in vital signs

    Time frame: Up to 5 Years

    Vital signs include systolic and diastolic blood pressure, heart rate, and body temperature

  10. Number of participants with clinically significant changes from baseline in clinical laboratory values

    Time frame: Up to 5 Years

    Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis

  11. Number of Participants With Clinically Significant Physical Examination Findings

    Time frame: Up to 5 Years

    A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Adult Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jul 29, 2022
Registry last updated
Mar 4, 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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