A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 97
- 主要终点
- Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without their cancer growing, spreading or returning (progression free survival).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion and
排除标准
- •include but are not limited to the following:
- •Inclusion Criteria:
- •Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy
- •Has previously untreated CLL/SLL participants without tumor protein 53 (TP53) aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV) mutational status
- •The ability to swallow and retain oral medication
- •Exclusion Criteria:
- •Has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Has gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
- •Has known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy
- •Has history of severe bleeding disorders
- •Has not adequately recovered from major surgery or has ongoing surgical complications
研究组 & 干预措施
Nemtabrutinib
Administered daily via oral tablet.
干预措施: Nemtabrutinib (Drug)
FCR or BR
Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
干预措施: Fludarabine (Drug)
FCR or BR
Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
干预措施: Cyclophosphamide (Drug)
FCR or BR
Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
干预措施: Bendamustine (Drug)
FCR or BR
Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
干预措施: Rituximab (Biological)
FCR or BR
Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
干预措施: Truxima (Biological)
FCR or BR
Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
干预措施: Ruxience (Biological)
FCR or BR
Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
干预措施: Riabni (Biological)
结局指标
主要结局
Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR)
时间窗: Up to approximately 49 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by blinded independent central review (BICR).
次要结局
- Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR(Up to approximately 94 months)
- Objective Response Rate (ORR) per iwCLL Criteria 2018 as Assessed by BICR(Up to approximately 36 months)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 94 months)
- Overall Survival (OS)(Up to approximately 94 months)
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 94 months)
- Time to Next Therapy (TTNT)(Up to approximately 94 months)