在新诊断的急性髓性白血病中低剂量venetoclax加伊特拉科纳门诊诱导:一项2期研究
Fernando De la Garza-Salazar1, Perla Rocío Colunga-Pedraza1, David Gómez-Almaguer1
1Univerisdad Autónoma de Nuevo León, Facultad de Medicina y Hospital Universitario "Dr. José Eleuterio González", Hematology service, Internal Medicine Department.
Leukemia research
|August 26, 2023
概括
用低剂量venetoclax和azacitidine的门诊诱导,结合伊特拉科纳来降低成本,是新诊断的急性髓性白血病 (ND-AML) 患者的可行和安全的第一线治疗方法.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 对于新诊断的急性髓性白血病 (ND-AML) 候选人进行密集化疗的第一线venetoclax和azacitidine (Ven/Aza) 的数据有限.
- 对于ND-AML的门诊诱导方案尚未得到充分研究.
- 作为CYP3A4抑制剂的伊特拉科纳可以将维内托克拉克斯剂量和成本降低75%
研究的目的:
- 评估ND-AML的门诊诱导治疗方案的可行性,安全性和有效性.
- 在门诊环境中评估低剂量venetoclax,伊特拉科纳和阿扎西提丁的组合.
主要方法:
- 第二阶段试验涉及15名患有ND-AML的成年人.
- 门诊诱导使用venetoclax (100毫克每天1-21天),伊特拉科纳 (100毫克每天两次每天1-21天) 和阿扎西提丁 (100毫克每天每天1-7天).
- 评估了患者的治疗完成率,死亡率和反应率.
主要成果:
- 60%的受试者作为门诊患者开始治疗,其中77.7%完成了第一轮治疗.
- 14,30和60天的早期死亡率分别为6.7%,13.3%和13.3%.
- 综合完全缓解率 (CR/CRi) 在周期1后为53.9%,在周期2后为85.7%. 常见的不良事件包括血液和胃肠道毒性.
结论:
- 用低剂量的venetoclax加上伊特拉科纳进行门诊诱导对于ND-AML患者来说是可行的和安全的.
- 这种疗法证明了可接受的初步疗效.
- 需要对门诊患者的基于Ven/Aza的治疗方案进行进一步的研究.
更多相关视频
相关概念视频
Drug Administration and Therapy Phases: Overview
521
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
521
Treatment Resistant Cancers
3.3K
Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
3.3K
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
195
Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
195
Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
149
Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
149
Clinical Trials: Overview
3.0K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.0K
Clinical Trials
6.8K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
6.8K


