EUCTR2020-004528-40-ES进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of SY-1425 Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, RARA-positive Adult Patients with Higher-risk Myelodysplastic Syndrome
Syros Pharmaceuticals, Inc0 个研究点目标入组 190 人开始时间: 2021年10月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients must be at least 18 years old at the time of signing of an informed consent.
- •2. Patients must be RARA-positive based on the investigational assay.
- •3. Patients must be newly diagnosed with HR-MDS as follows:
- •Diagnosis of MDS according to the WHO classification (Arber 2016) and classified by the IPSS-R risk category as:
- •a. Very High (risk score >6),
- •b. High (risk score >4.5 to 6), OR
- •c. Intermediate (risk score >3 to 4.5).
- •4. Patients must have measurable disease with bone marrow blasts >5% at the Screening Visit.
- •5. Patients must have ECOG Performance Status of =2.
- •6. Patients must have adequate organ function, as defined by:
- •a. total bilirubin < or = 3.0 × the ULN,
- •b. ALT and AST < or = 3 × ULN,
- •c. creatinine clearance > or = 30 mL/min based on the Cockcroft-Gault Glomerular Filtration Rate estimation.
- •7. Patients must have a serum/urine pregnancy test (for females of childbearing potential) that is negative at the Screening Visit and immediately prior to initiation of treatment (first dose of study drug).
- •8. Patients must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraceptive requirements (as described in Appendix 4), and other procedures.
- •9. Patients must be capable of giving signed and dated IRB or IEC approved informed consent document.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 161
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •1. Patients are suitable for and agree to undergo allogeneic HSCT at the time of screening.
- •2. Patients received prior treatment for MDS with any hypomethylating agent, chemotherapy (including lenalidomide), or allogeneic HSCT, with the exception of prior treatment with growth factors or hydroxyurea. Growth factor treatment must be discontinued at least 2 weeks prior to starting study drug. Hydroxyurea treatment must be discontinued prior to starting study drug.
- •3. Patients are currently receiving treatment for a malignancy (not including basal cell carcinoma, non-melanoma skin cancer, cervical carcinoma in situ, or localized prostate cancer treated with hormone therapy). Patients with history of other cancers should be free of disease for at least 2 years prior to the Screening Visit.
- •4. Patients have an active, life-threatening, or clinically-significant, uncontrolled systemic infection requiring hospitalization.
- •5. Patients have a known malabsorption syndrome or other condition that may impair absorption of study medication (e.g., gastrectomy).
- •6. Immunocompromised patients with increased risk of opportunistic infections, including known HIV-positive patients with CD4 counts < or =350 cells/mm3 or history of opportunistic infection in the last 12 months. Note: To ensure that effective ART, when used in eligible HIV-positive patients, is tolerated and that toxicities are not confused with investigational drug toxicities, patients should be on an established ART for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to the Screening Visit.
- •7. Patients have a known active or chronic hepatitis B or active HCV infection. Patients with a history of HCV infection who have completed curative therapy for HCV at least 12 weeks before the Screening Visit and have a documented undetectable viral load at the Screening Visit are eligible for enrollment.
- •8. Patients have other severe acute or chronic medical conditions (and/or psychiatric conditions or laboratory abnormalities) that may increase the expected risk to the patient (i.e., the risk associated with the study participation or investigational product administration), or that may interfere with the interpretation of study results or, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •9. Patients received prior treatment with ATRA or systemic retinoid for a hematologic malignancy.
- •10. Patients have not adequately recovered from a major surgery within 4 weeks of starting study drug administration.
- •11. Patients with a diagnosis of hypervitaminosis A or patients taking vitamin A supplements >10,000 IU/day, unless treatment is discontinued at least 7 days prior to the first dose of the study drug.
- •12. Patients known to be refractory to platelet or packed red blood cell transfusions per Institutional Guidelines, or patients who refuse blood product support.
- •13. Patients received strong inducers of CYP3A4 (see Appendix 6) within 2 weeks of the first SY-1425/placebo administration.
- •14. Patients received any other investigational agents within 4 weeks of the Screening Visit, or <5 half-lives since completion of previous investigational therapy have elapsed, whichever is shorter.
- •15. Patients require concurrent treatment with any investigational or approved oncology agent.
- •16. Patients with > or = 20% blasts in peripheral blood or bone marrow
- •17. Patients with Grade > or = 2 hypertriglyceridemia, defined as >300 mg/dL (CTCAE, v
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