Active — Not RecruitingPhase 2

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

China100 participantsStarted 2022-10-25

Plain-language summary

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)

Who can participate

Age range18 Years

SexALL

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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

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

What they're measuring

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

Timeframe: Up to 2 Years

Trial details

NCT IDNCT05479994

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-24

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