KCT0004821尚未招募未知
Role of hypomethylating agents to improve survival outcomes in patients with high-risk acute myeloid leukemia who underwent allogeneic stem cell transplantation
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. Patients with high-risk acute myeloid leukemia (AML) who underwent allogeneic stem cell transplantation
- •(High-risk AML: patients with adverse risk group according to the 2017 ELN risk stratification by genetics, patients with primary refractory disease, and patients with first relapse after achieving complete remission [CR].)
- •** Adverse risk category of 2017 ELN risk stratification by genetics (2017 ELN recommendation)
- •t(6;9)(p23;q34.1); DEK-NUP214
- •t(v;11q23.3); KMT2A rearranged
- •t(9;22)(q34.1;q11.2); BCR-ABL1
- •inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2, MECOM(EVI1)
- •-5 or del(5q); -7; -17/abn(17p)
- •Complex karyotype, monosomal karyotype
- •Wild-type NPM1 and FLT-ITDhigh
- •Mutated RUNX1
- •Mutated ASXL1
- •Mutated TP53
- •2. Bone marrow blast should be less than 5%, and absolute neutrophil count and platelet count should be over 1,000/uL and 50,000/uL, respectively.
- •3. Men and women =19, < 70 years of age
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2.
- •5. Patients who achieved CR after allogeneic stem cell transplantation
- •1) Complete remission (CR)
- •- Bone marrow blasts < 5%
- •- Absence of blasts with Auer rods
- •- Absence of extramedullary disease
- •- Absolute neutrophil count > 1.0 x 109/L (1000/uL)
- •- Platelet count > 80 x 109/L (80,000/uL)
- •- Independence of red cell transfusions
- •2) CR with incomplete recovery
- •- All CR criteria except for residual neutropenia (< 1.0 x 109/L [1000/uL]) or thrombocytopenia (< 80 x 109/L [80,000/uL])
- •6. Patients with adequate liver, kidney, heart function.
- •7. Patients who can evaluate chimerism every 4 weeks
- •8. Woman of childbearing potential who are sexually active must have negative urine hCG test prior to the treatment. Participants must use 2 methods including at least 1 highly effective method of contraception during treatment period and for 4 weeks after the treatment.
- •9. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- •10. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
排除标准
- •1. Treatment history with hypomethylating agent
- •2. Prior malignancy (or any other malignancy that requires active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, papillary thyroid carcinoma or other cancer from which the subject has been disease free for over 5 years or which will not limit survival to less than 5 years.
- •3. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
- •4. Known history of infection with HIV or any uncontrolled active systemic infection (e.g. Bacterial, vial or fungal).
- •5. History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/haemorrhage, severe brain injuries, dementia, parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder) within 6 months before the treatment.
- •6. Total bilirubin > 3 x ULN, or AST, ALT > 3 x ULN
- •7. Creatinine > 2 x ULN
- •8. Breastfeeding or pregnant.
- •9. Concurrent participation in another therapeutic clinical trial.
研究者
相似试验
招募中
2 期
Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) PatientsAcute Myeloid LeukemiaNCT06379360The First Affiliated Hospital of Soochow University77
招募中
2 期
Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse PreventionT-cell Acute Lymphoblastic LeukemiaALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONRelapseNCT06686108Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine59
尚未招募
Unknown
Post-transplant therapy in adult acute lymphoblastic leukemia patientsNeoplasmsKCT0008883Kyungpook National University Medical Center33
招募中
2 期
Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRDAcute Myeloid LeukemiaNCT06511882H. Lee Moffitt Cancer Center and Research Institute37
已完成
1 期
A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast CancerAdvanced or Metastatic Solid TumorsAdvanced or Metastatic Breast CancerNCT00748553University of Utah30