CTRI/2023/09/057552尚未招募1 期
A Phase I study of maintenance therapy with combination of pomalidomide and oral azacytidine for adult patients with Acute Myeloid Leukaemia (AML). - Nil
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
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
入选标准
- •1. Age greater than or equal to 18 yrs.
- •2. Immunophenotypically confirmed diagnosis of Acute myeloid leukaemia
- •3. Patients with secondary AML progressed from antecedent myelodysplasia are also eligible.
- •4. In complete remission (CR or CRi) hematological recovery after induction therapy (maximum two courses of induction therapy are allowed).
- •Absolute neutrophil count shall be greater than equal to 1000 per ul and Platelet count greater than equal to 75000 per ul. Patients who have received consolidation therapy (any number of cycles between 0 and 3) can be enrolled in the study.
- •5. Absence of circulating blasts (bone marrow should contain less than 5% blasts, Auer rods should be absent, extramedullary leukaemia should be absent).
- •6. ECOG PS less than equal to 2.
- •7. Patients who tolerated cycle 1 oral azacytidine without any grade 3, 4 haematological toxicities as per Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
- •8. Patient must have provided written and informed consent for participation.
- •9. For females of childbearing potential following to be followed
- •Females should be willing and able to comply with the use of contraception for at least 4 weeks before starting Pomalidomide treatment and 4 weeks after stopping Pomalidomide treatment.
- •10. For Men - must agree to use a latex condom during any sexual contact with women of childbearing potential while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy.
排除标准
- •1.Planned allogeneic hematopoietic cell transplantation
- •2. Blast crisis of chronic myeloid leukaemia
- •3. AML-FAB type M3 or AML with cytogenetic abnormality t (15;17)
- •4. Treatment with azacytidine with or without venetoclax as induction therapy
- •5.Subject has clinically significant cardiac disease, including:
- •a.Myocardial Infarction within 1 year before randomization, or an unstable or uncontrolled disease/condition to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III and IV.
- •b.Cardiac Arrhythmia (NCI CTCAE Version 5 Grade greater than equal to 2) or clinically significant ECG abnormalities.
- •6. LVEF greater than 50 percent.
- •7. Impaired hepatic or renal function as defined by:
- •a.ALT and/or AST greater than 3 x upper limit of normal
- •b.Bilirubin greater than 3 x upper limit of normal
- •8. Calculated creatinine clearance of less than 50 ml per min (Cockroft-Gault formula)
- •9. Pre-existing baseline greater than grade 1 peripheral neuropathy
- •10. Subject has contraindications to required prophylaxis (i.e. Low Molecular Weight Heparins) for deep vein thrombosis and pulmonary embolism.
- •11. Gastrointestinal disease that may significantly alter the absorption of oral drugs.
- •12. Active serious infection not controlled by oral or intravenous antibiotics one week before participation.
- •13. Pregnancy and lactation.
研究者
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