ISRCTN30808508进行中（未招募）2 期
A randomised phase 2 study of ASTX727 versus best supportive care in(MDS/MPN) Overlap Syndromes
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 77
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. =18 years of age at the time of trial entry
- •2. Morphologically confirmed diagnosis of MDS/MPN (excluding JMML), in accordance with WHO 2016 diagnostic criteria, with any of the following characteristics:
- •2.1. CMML-2 disease stage [CMML only]
- •2.2. CPSS [Such et al Blood 2013] or CPSS-Mol [Elena et al Blood 2016] score of intermediate-2 or high risk [CMML only]
- •2.3. Other patients with one or more of the following:
- •2.3.1. Bone Marrow blasts >10% (including promonocytes)
- •2.3.2. Adverse risk cytogenetics (as defined by CPSS or MDS R-IPSS)
- •2.3.3. WCC =50 (or =30 with symptoms attributable to myeloproliferation)
- •2.3.4. RBC transfusion dependence with pre-transfusion Hb <90 g/L
- •2.3.5. Symptomatic anaemia (with Hb =100 g/L)
- •2.3.6. Thrombocytopenia (Plt =50 x 10^9/L)
- •2.3.7. Symptomatic splenomegaly
- •2.3.8. Systemic symptoms with no alternative explanation (including weight loss =10% of baseline over previous 6 months)
- •2.3.9. Symptomatic extramedullary involvement (e.g. skin infiltration, serous effusions)
- •3. Treatment-naïve for prior hypomethylating agent, intensive chemotherapy or other disease-modifying anti-neoplastic therapy (e.g. lenalidomide); patients may have received prior hydroxycarbamide,recombinant erythropoietin, danazol, interferon or anagrelide.
- •4. ECOG performance status of 0,1 or 2 at trial entry (Appendix 3).
- •5. Life expectancy of =3 months at trial entry,as assessed by the treating physician.
- •6. Must have adequate hepatic, renal and endocrine function during screening as demonstrated by the following:
- •6.1. ALT and/or AST =3x upper limit of normal (ULN);
- •6.2. Total bilirubin =1.5x ULN or =2x ULN if upon judgement of the treating investigator the hyperbilirubinaemia is due to extramedullary haematopoiesis related to the underlying MDS/MPN or to Gilbert’s disease;
- •6.3. Serum creatinine =1.5x ULN or estimated creatinine clearance >/=30ml/min/1.73m².
- •7. Patient willing and able to comply with scheduled visits,treatment plan and other study procedures.
- •8. Patient able to provide written informed consent for the trial
排除标准
- •1. Patients eligible for intensive chemotherapy and/or allogeneic haematopoietic stem cell transplantation (HSCT).
- •2. CMML with eosinophilia and 5q33 abnormality.
- •3. Previous cytotoxic chemotherapy for MDS/MPN, except hydroxycarbamide.
- •4. Prior hypomethylating agent exposure.
- •5. Transformation to AML (=20% myeloid blasts in bone marrow or peripheral blood at screening).
- •6. Prior organ transplantation, including allogeneic haematopoietic stem cell transplant (HSCT).
- •7. Known or suspected central nervous system disease involvement.
- •8. Known history of clinically significant or uncontrolled cardiac disease, including recent history (within 6 months) of unstable angina, acute myocardial infarction, NYHA class III or IV congestive cardiac failure, or clinically significant arrhythmia.
- •9. Other active malignancy, not including localized non-melanoma skin cancer, cervical carcinoma in situ, breast ductal carcinoma in situ of the breast, or localized prostate cancer controlled with hormone therapy. Patients with history of other cancers should be free of disease without ongoing anti-neoplastic therapy for at least 2 years.
- •10. Receipt of wide-field radiotherapy (including therapeutic radioisotopes) =28 days or limited field radiation for palliation =14 days prior to starting any study medications (or has not recovered from side effects of such therapy).
- •11. Active,uncontrolled infection. Patients with infection under control with active treatment are eligible.
- •12. Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry).
- •13. Females of childbearing potential, and their partners, not willing to use adequate contraception during and for up to 6 months after treatment.
- •14. Any other concurrent serious or unstable medical, psychiatric, familial, geographic or sociological condition that in the investigator’s opinion would jeopardise the patient’s ability to comply with the protocol.
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)ower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)MedDRA version: 20.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851MedDRA version: 27.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-003281-40-BETaiho Oncology, Inc.128
进行中（未招募）
1 期
A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)ower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)MedDRA version: 20.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851MedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-003281-40-ESAstex Pharmaceuticals, Inc.168
进行中（未招募）
1 期
A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)ower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)MedDRA version: 20.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851MedDRA version: 27.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-003281-40-DETaiho Oncology, Inc.168
进行中（未招募）
1 期
A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)EUCTR2019-003281-40-ITASTEX PHARMACEUTICALS128
招募中
2 期
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)Secondary MyelofibrosisEssential ThrombocythemiaPolycythemia VeraPrimary MyelofibrosisNCT06661915National Cancer Institute (NCI)78