2024-518858-17-00招募中2 期
The MAVRiC Study: A Phase II Study of Disease Risk Mutation-guided Finite Duration Acalabrutinib plus Venetoclax for Relapse in CLL/SLL after First-line Finite covalent BTKi plus BCL2i combination, with or without Obinutuzumab
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 22
研究概览
简要总结
To determine the efficacy of second-line (2L) treatment with acalabrutinib plus venetoclax (AV) after relapse following first-line (1L) covalent Bruton’s tyrosine kinase inhibitor (cBTKi) + B-cell leukemia/lymphoma-2 inhibitor (BCL2i) by assessment of overall response rate (ORR) in participants with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL)
研究设计
- 分配方式
- Na
- 主要目的
- Post-intervention follow-up periods
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 18 years at the time of signing informed consent.
- •Diagnosis of CLL/SLL according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines 2018 (Hallek et al. 2018)
- •Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ partial remission (PR) (i.e., complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or PR) with a minimum of 2 years since the end of the prior 1L treatment.
- •The following data must be available or at least the appropriate samples drawn/acquired prior to dosing: a) variable region of immunoglobulin heavy chain (IGHV) (mutated vs. unmutated) b) 17p deletion [del(17p)] (present or absent) c) Tumor protein 53 (TP53) mutation (present or absent)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •Adequate organ and bone marrow (BM) function.
排除标准
- •Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study.
- •History of hypersensitivity or anaphylaxis to study intervention(s).
- •Requires treatment with a strong CYP3A4 inhibitor/inducer.
- •Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
- •Major surgical procedure within 30 days of the first dose of study intervention.
- •Significant cardiovascular or cerebrovascular disease.
- •Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).
- •Child-Pugh B/C liver cirrhosis.
- •History of prior or current malignancy.
- •HIV positive
- •History of progressive multifocal leukoencephalopathy (PML).
- •Active hepatitis B or C infection:
- •Corticosteroid use > 20 mg within 1 week before the first dose of study intervention.
研究组 & 干预措施
Calquence 100 mg film-coated tablets
Test
干预措施: Calquence 100 mg film-coated tablets (Drug)
Venclyxto 100 mg film-coated tablets, Venclyxto 50 mg film-coated tablets, Venclyxto 10 mg film-coated tablets, Venclyxto 100 mg film-coated tablets, Venclyxto 100 mg film-coated tablets
Test
干预措施: Venclyxto 100 mg film-coated tablets (Drug)
Venclyxto 100 mg film-coated tablets, Venclyxto 50 mg film-coated tablets, Venclyxto 10 mg film-coated tablets, Venclyxto 100 mg film-coated tablets, Venclyxto 100 mg film-coated tablets
Test
干预措施: Venclyxto 50 mg film-coated tablets (Drug)
Venclyxto 100 mg film-coated tablets, Venclyxto 50 mg film-coated tablets, Venclyxto 10 mg film-coated tablets, Venclyxto 100 mg film-coated tablets, Venclyxto 100 mg film-coated tablets
Test
干预措施: Venclyxto 10 mg film-coated tablets (Drug)
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (22)
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