跳至主要内容
临床试验/NCT04895436
NCT04895436
招募中
2 期

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia

AbbVie114 个研究点 分布在 8 个国家目标入组 75 人2022年3月28日

概览

阶段
2 期
干预措施
Obinutuzumab
疾病 / 适应症
Chronic Lymphocytic Leukemia (CLL)
发起方
AbbVie
入组人数
75
试验地点
114
主要终点
Overall response (OR) in Cohort 1 after end of combination treatment
状态
招募中
最后更新
2个月前

概览

简要总结

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed.

Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide.

Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

注册库
clinicaltrials.gov
开始日期
2022年3月28日
结束日期
2029年1月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
AbbVie
责任方
Sponsor

入排标准

入选标准

  • Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.
  • Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission.
  • More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment.

排除标准

  • \- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.

研究组 & 干预措施

Cohort 2 - venetoclax + obinutuzumab

Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.

干预措施: Obinutuzumab

Cohort 1 - venetoclax + obinutuzumab

Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.

干预措施: Venetoclax

Cohort 1 - venetoclax + obinutuzumab

Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.

干预措施: Obinutuzumab

Cohort 2 - venetoclax + obinutuzumab

Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.

干预措施: Venetoclax

结局指标

主要结局

Overall response (OR) in Cohort 1 after end of combination treatment

时间窗: 9 months

OR is defined as the percentage of participants achieving a best response of partial remission (PR), nodular partial remission (nPR), complete remission with incomplete marrow recovery (CRi), or complete remission (CR). Disease assessments will be based on the 2018 International Workshop for Chronic Lymphocytic Leukemia (iwCLL) criteria for tumor response.

次要结局

  • Time to Next Treatment (TTNT) for CLL in Cohort 1(15 months)
  • Progression-free Survival (PFS) in Cohort 1(15 months)
  • Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment(9 months)
  • OR in Cohort 1 after end of combination treatment(9 months)
  • OR in Cohort 1 after end of treatment(15 months)
  • Duration of Response (DOR) in Cohort 1(15 months)
  • Overall Survival (OS) in Cohort 1(15 months)
  • Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment(15 months)
  • Time to Response (TTR) in Cohort 1(15 months)

研究点 (114)

Loading locations...

相似试验