ISRCTN71474257终止2 期
A Phase II, randomised, open-label study evaluating the safety and efficacy of magrolimab in combination with venetoclax and azacitidine versus intensive chemotherapy in fit adults with high risk newly diagnosed acute myeloid leukaemia
DIDACT Foundation0 个研究点目标入组 164 人开始时间: 2023年9月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 164
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 to 70 years of age at the time of signing the Informed Consent Form (ICF)
- •2. Able to provide written informed consent for the study
- •3. Willing and able to adhere to the study visit schedule, treatment plan and other protocol requirements
- •4. Newly diagnosed acute myeloid leukaemia (AML) (previously untreated for AML) and morphological confirmation of AML fulfilling European LeukaemiaNet (ELN) 2022 criteria
- •5. Patients must be considered fit for intensive chemotherapy (IC) by the treating Investigator, using DA, DA+GO, CPX-351 (Vyxeos) or FLAG-Ida, and have either:
- •5.1. Adverse risk AML as defined by the ELN 2022 criteria and be 18 to 70 years of age; OR
- •5.2. Intermediate risk AML according to the ELN 2022 criteria and be 50 to 70 years of age
- •6. Genotype FLT3-ITD mutation-negative
- •7. ECOG performance status 0-2
- •8. Adequate renal function, as demonstrated by serum creatinine =1.5 x upper limit of normal (ULN)
- •9. Adequate liver function, as demonstrated by:
- •9.1. Aspartate aminotransferase (AST) =3 ULN
- •9.2. Alanine aminotransferase (ALT) =3 ULN
- •9.3. Total bilirubin =3 x ULN
- •10. Adequate cardiac function as demonstrated by left ventricular ejection fraction (LVEF) = 50% by echocardiogram (ECHO)
- •11. Patients must agree to use an adequate and medically accepted method of contraception throughout the study if they or their sexual partners are female-born of childbearing potential
- •11.1. Arm A patients: These measures must be in place during the study and for 3 months after the last dose of study treatment
- •11.2 Arm B female-born patients of childbearing potential: These measures must be in place during the study and for 6 months after the last dose of study treatment
- •11.3 Arm B non-sterilised male-born patients with female partners of childbearing potential: These measures must be in place during the study and for 3 months after the last dose of study treatment
- •11.4. Male-born patients should be advised to not father a child while receiving study treatment
- •11.5 Female-born patients of childbearing potential must agree to avoid becoming pregnant while on protocol treatment
- •12. Negative pregnancy test within 2 weeks prior to randomisation in female-born patients of childbearing potential
- •13. Pre-treatment blood cross-match completed
排除标准
- •1. Have received previous cytotoxic chemotherapy (intensive or non-intensive), targeted therapies, hypomethylating agents or venetoclax for AML or any other antecedent haematological condition, with the exception of hydroxycarbamide to control white blood cell (WBC) count or lenalidomide for treatment of myelodysplasia (MDS) 5q syndrome
- •2. Have received prior treatment with CD47 or signal regulatory protein alpha-targeting agents
- •3. Are in blastic transformation of chronic myeloid leukaemia (CML)
- •4. Clinical suspicion of active central nervous system (CNS) involvement with AML
- •5. Are not deemed fit for intensive chemotherapy (IC) on the basis of age or comorbidities
- •6. Have secondary malignancy, except MDS, treated basal cell carcinoma or localised squamous skin carcinomas, localised prostate cancer, or other malignancies for which patients are not on active anti-cancer therapies and have had no evidence of active malignancy for at least 1 year. Note: patients on maintenance therapy alone, who have no evidence of active malignancy for at least 1 year are eligible
- •7. Have acute promyelocytic leukaemia (APL)
- •8. Known newly diagnosed or uncontrolled human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. Patients with known chronic infections may enrol if the last two tests for viral load have been negative and their current therapy does not include a protease inhibitor or a non-nucleoside reverse-transcriptase inhibitor
- •9. Significant disease or medical conditions, as assessed by the Investigator, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to:
- •9.1. Acute myocardial infarction within 6 months of randomisation,
- •9.2. Unstable angina, cerebrovascular accident (CVA), transient ischemic attack (TIA), uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III to IV, within 3 months of randomisation.
- •10. History of Wilson’s disease or other copper-metabolism disorder
- •11. Pre-existing liver impairment with known cirrhosis
- •12. Judgement by the local Investigator that the patient should not participate in the study, if the patient is unlikely to comply with study procedures, restrictions and requirements
- •13. Concomitant use of:
- •13.1. Any strong or moderate CYP3A inhibitors, except posaconazole or voriconazole
- •13.2. Any strong or moderate CYP3A inducers
- •13.3. Preparations containing St John’s Wort
- •14. Known history, diagnosis or suspicion of haemophagocytic lymphohistiocytosis syndrome (HLH)
- •15. Pregnant and lactating patients
- •16. Female-born patients of childbearing potential, or male-born patients with female partners of childbearing potential, not willing to use adequate contraception during study and for the required contraceptive periods
- •17. Patients who are unable to swallow tablets whole
- •18. Unable to understand and therefore to give voluntary consent
- •19. Known hypersensitivity to any of the IMPs, the metabolites or formulation excipients
- •20. Current participation is another interventional clinical study. Patients in follow-up who have not received the interventional treatment within 4 weeks of randomisation may enrol.
- •21. Patients receiving any live vaccine within 4 weeks prior to initiation of study treatments
- •22. Patients known to require vaccination with a live vaccine during the treatment period or for 3 months after the end of study treatment
- •23. Known inherited or
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