A Multicentric Phase I/II Study of Jaktinib Hydrochloride Tablets in Combination With Azacitidine for Injection in Patients With Myelodysplastic Syndromes(MDS) With Myelofibrosis(MF) or MDS/Myeloproliferative Neoplasms With MF
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Objective response rate (complete remission+cytogenetic complete remission+partial remission+clinical improvement) in patients with myelodysplastic syndromes/myeloproliferative neoplasms
研究概览
简要总结
This phase I/II trial studies how well Jaktinib and azacytidine work in treating patients with myelodysplastic syndromes with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm with myelofibrosis. Giving Jaktinib and azacytidine may be an effective treatment for myelodysplastic syndromes with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm with myelofibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects voluntarily sign the informed consent form (ICF);
- •Age ≥ 18 years, either male or female;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- •Expected life expectancy is greater than 24 weeks;
- •Diagnosis of myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) according to World Health Organization (WHO)；
- •The patients understands the purpose of and procedures required for the study and is willing to participate in the study；
排除标准
- •Subjects with congestive heart failure, uncontrolled or unstable angina or myocardial infarction,cerebrovascular accident, or pulmonary embolism within 6 months prior to screening;
- •Subjects suffering from arrhythmia and requiring treatment, or QTcB > 480ms at screening;
- •Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening;
- •Subjects with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC);
- •Female subjects who are pregnant, currently breastfeeding, planning to become pregnant;
- •Subjects who had experienced malignant tumors (except for adequately treated local basal cell or squamous cell carcinoma of the skin and cervical carcinoma in situ that have been cured) within the past 5 years;
- •Subjects who have any other conditions that are not specified in the protocol but the investigator believes that they are not suitable for inclusion in this trial.
研究组 & 干预措施
Treatment(Jaktinib+Azacitidine)
Patients receive azacitidine subcutaneously (SC) on days 1-7 and Jaktinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Jaktinib (Drug)
Treatment(Jaktinib+Azacitidine)
Patients receive azacitidine subcutaneously (SC) on days 1-7 and Jaktinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: azacitidine (Drug)
结局指标
主要结局
Objective response rate (complete remission+cytogenetic complete remission+partial remission+clinical improvement) in patients with myelodysplastic syndromes/myeloproliferative neoplasms
时间窗: Up to16 weeks
According to the 2015 ICP in MDS/MPN. The objective response rate will be estimated along with the Bayesian 95% credible interval.
Objective response rate (complete remission+partial remission+marrow compete remission +cytogenetic complete remission + hematological improvement) in patients with Myelodysplastic Syndromes
时间窗: Up to16 weeks
According to the 2006 International Working Group (IWG) response criteria in myelodysplasia，The objective response rate will be estimated along with the Bayesian 95% credible interval.
次要结局
- Overall survival(Time from treatment start till death or last follow-up, assessed up to 2 years)
- Relapse-free survival(Time from start of response to the date of event defined as the first documented progressive disease/relapse or death, whichever comes first, assessed up to 2 years)
- Duration of response(Duration from the first documented onset of partial response or complete response to the date of progressive disease/relapse, assessed up to 2 years)