EUCTR2020-004453-71-DE招募中1 期
A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2 - AMLSG 31-19 / HOVON 501 / AbbVie B18-982
niversity Hospital Ulm0 个研究点目标入组 650 人开始时间: 2021年7月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 650
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.Patients with newly diagnosed acute myeloid leukemia (AML), or myelodysplastic syndrome with excess blasts-2 (MDS-EB2) according to World Health Organization (WHO) classification
- •2.Age = 18 years, no upper age limit.
- •3.Patients considered eligible for intensive chemotherapy.
- •4.Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- •5.Molecular analysis centrally performed in AMLSG and HOVON laboratories.
- •6.Adequate renal function as evidenced by serum creatinine = 2.0 × upper limit of normal (ULN) or creatinine clearance >40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR).
- •7.Adequate hepatic function as evidenced by:
- •oSerum total bilirubin = 2.5 × ULN unless considered due to Gilbert’s disease, or leukemic involvement following approval by the Principal Investigator or Trial Coordinator
- •oAspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 3.0 × ULN, unless considered due to leukemic involvement following approval by the Principal Investigator or Trial Coordinator.
- •8.No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell [WBC] counts > 25x109/L); patients may have had previous treatment with erythroid stimulating agents (ESA) or hypomethylating agents (HMAs) for an antecedent phase of MDS; ESA and HMAs have to be stopped at least four weeks before start of study treatment.
- •9.Patients must not have received a known strong or moderate CYP3A inducer 7 days before start of study treatment. Patients must have no known medical conditions requiring chronic therapy of moderate or strong CYP3A inducers.
- •10.Female patient must either:
- •o Be of nonchildbearing potential:
- •Postmenopausal (defined as at least 1 year without any menses)
- •Documented surgically sterile (e.g. documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or congenital sterile) or status posthysterectomy (at least 1 month prior to screening)
- •o Or, if of childbearing potential (not surgically sterile and not postmenopausal)
- •Not planning to become pregnant during the study and for 6 months after the final study drug administration
- •And have a negative urine or serum pregnancy test at screening
- •And, if heterosexually active, agree to consistently apply one highly effective* method of birth control in combination to a barrier method for the duration of the study and for 27 weeks after the final study drug administration.
- •*Highly effective forms of birth control include
- •?Consistent and correct usage of established hormonal contraceptives that inhibit ovulation, for at least 1 month prior to taking study drug.
- •(Hormonal contraception is only a highly effective method of birth control, if a combined (estrogen and progestogen containing) hormonal contraception or a progestogen-only hormonal contraception – both associated with inhibition of ovulation - is used.)
- •?Established intrauterine device (IUD) or intrauterine system (IUS),
- •?Bilateral tubal occlusion,
- •?Vasectomy - a vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.
- •?Male is sterile due to a bilateral orchiectomy.
- •?Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity durin
排除标准
- •1.Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12); PML-RARA; or one of the other pathognomonic variant chromosomal translocations/ fusion genes.
- •2.AML with BCR-ABL1; or myeloid blast crisis of CML.
- •3.Patients with AML and activating FLT3 mutations who have access (including reimbursement) to treatment with a FLT3 inhibitor approved for first-line therapy of AML.
- •4.Prior treatment of MDS with intensive chemotherapy or allogeneic hematopoietic cell transplantation (HCT) with a curative intent.
- •5.Significant active cardiac disease within 6 months prior to the start of study treatment, including:
- •oNew York Heart Association (NYHA) class III or IV congestive heart failure;
- •oMyocardial infarction;
- •oUnstable angina and/or stroke;
- •oSevere cardiac arrhythmias
- •oLeft ventricular ejection fraction (LVEF) <40% by ultrasound obtained within 28 days prior to the start of study treatment.
- •6.Severe obstructive or restrictive ventilation disorder.
- •7.Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required, if there is a clinical suspicion of CNS involvement by leukemia during screening.
- •8.Active infection, including hepatitis B or hepatitis C antibody or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial; an infection controlled with an approved antibiotic/ antiviral/ antifungal treatment that is not a strong or moderate CYP3A inducer is allowed.
- •9.Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and/or disseminated intravascular coagulation.
- •10.Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.
- •11.Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at <30% risk of relapse within one year. However, patients with the following history/concurrent conditions are allowed:
- •oBasal or squamous cell carcinoma of the skin;
- •oCarcinoma in situ of the cervix;
- •oCarcinoma in situ of the breast;
- •oIncidental histologic finding of prostate cancer.
- •12.Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patients, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy).
- •13.Severe neurological or psychiatric disorder interfering with ability to give an informed consent.
- •14.Known or suspected hypersensitivity to any of the chemotherapeutic agents used.
- •15.No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation.
- •16.No consent for biobanking of patient’s biological specimens.
- •17.Participation in other prospective studies with anti-leukemic and/or investigational agents.
- •18.The patient is a pregnant or lactating woman, or plans to become pregnant during the study.
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