EUCTR2019-000473-23-FR进行中（未招募）1 期
A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia who are not Candidates for Intensive Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
入选标准
- •Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- •1. =18 years of age
- •2. AML according to WHO 2016 criteria and fulfilling all of the following criteria that defines not candidates for intensive chemotherapy”:
- •? =75 years of age or
- •? Comorbidity of at least one of the following:
- •o Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
- •o Severe cardiac comorbidity defined as congestive heart failure or ejection fraction =50%
- •o Severe pulmonary comorbidity defined as documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) =65% of expected, or forced expiratory volume in 1 second (FEV1) =65% of expected or dyspnea at rest requiring oxygen
- •o Moderate hepatic impairment defined according to National Cancer Institute (NCI) organ dysfunction classification criteria (total bilirubin =1.5 up to 3 times upper lmit of normal [ULN])
- •o Creatinine clearance <45 mL/ min/1.73 m² (by MDRD formula)
- •o Comorbidity that, in the Investigator’s opinion, makes the patient unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization
- •? De novo or secondary AML;
- •? Previously untreated AML (except: emergency leukapheresis, 1 low dose of cytarabine and/or hydroxyurea during the screening phase to control hyperleukocytosis but must be discontinued at least one day prior to start of azacitidine). All trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia is permitted but must be discontinued at least 1 day prior to the start of azacitidine;
- •? Not eligible for an allogeneic hematopoietic stem cell transplantation.
- •3. ECOG Performance Status score of 0, 1 or 2.
- •4. The following clinical laboratory values at screening:
- •? Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <3 times ULN; for participants with leukemic infiltration of the liver (documented by biopsy or imaging), AST and ALT <5 times ULN is permitted
- •? Total bilirubin = 3 times ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin or in case of liver infiltration by AML (documented by biopsy or imaging) serum total bilirubin <5 times ULN
- •? Creatinine Clearance >30 mL/min (by MDRD formula)
- •5. A woman must be either:
- •? Not of childbearing potential: postmenopausal (>45 years of age with amenorrhea for at least 12 months);
- •? Of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies for at least 3 months: eg, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of th
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •1. Acute promyelocytic leukemia with t (15;17), or its molecular equivalent (PML-RARa).
- •2. Leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system.
- •3. Use of immune suppressive agents for the past 4 weeks before the first administration of cusatuzumab on Cycle 1 Day 1. For regular use of systemic corticosteroids, participants may only be included if free of systemic corticosteroids for a minimum of 5 days before the first administration of cusatuzumab.
- •4. Prior treatment with a hypomethylating agent for treatment of AML or MDS
- •5. A diagnosis of other malignancy that requires concurrent non surgical treatment
- •6. Any active untreated systemic infection
- •7. A history of human immunodeficiency virus (HIV) antibody positive or tests positive for HIV if tested at screening
- •8. Active systemic hepatitis infection requiring treatment or other clinically active liver disease
- •9. New York Heart Association Class IV heart failure or ongoing unstable angina
- •10. Known allergies, hypersensitivity, or intolerance to cusatuzumab or azacitidine or its excipients (ie, mannitol, an excipient of azacitidine).
- •11. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or physical limitations that could prevent, limit, or confound the protocol-specified assessments.
- •12. Major surgery, (eg, requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study.
- •Note: participants with planned surgical procedures to be conducted under local
- •anesthesia may participate. In such cases, the investigator must notify the Sponsor before randomization.
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