EUCTR2015-001767-40-IT进行中（未招募）1 期
A phase II study testing the efficacy of combined azacitidine and lenalidomide for non-M3 acute myeloid leukemia (AML) patients aged between 60 and 70 years, fit, relapsed or refractory: the AZALEA study - AZALEA
AZIENDA OSPEDALIERA OSPEDALI RIUNITI MARCHE NORD0 个研究点目标入组 66 人开始时间: 2021年9月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
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
- 性别
- All
入选标准
- •Diagnosis of relapsed AML. A prior CR duration of at least 2 months is required to met the definition of relapsed AML. Patients must have not received more than 1 re-induction course prior to enter the study.
- •Diagnosis of resistant AML. Patients must have received, at the upmost, 2 courses of therapy (first induction and first salvage course) before entering the study, in order to be eligible for enrolment.
- •Patients relapsing after stem cell transplantation, both autologous and allogeneic, are eligible.
- •HIV negativity.
- •Male and female patients aged = 60 and = 70 years.
- •Signed informed consent
- •Morphologically confirmed diagnosis of non-M3 acute myeloid leukemia (AML) in first or subsequent relapse by bone marrow aspiration
- •WBC count = 30,000/mm³. A pretreatment with single dose vinblastine in order to reduce the white blood cell count is allowed within 7 days from the start of therapy. Cytoreduction with hydroxyurea is not allowed.
- •Patient must be not eligible for or not interested in conventional salvage therapies.
- •Fertile male patients must use a condom during sexual contact with a pregnant female or a FCBP while taking lenalidomide, during dose interruptions and for at least 28 days after the last dose of lenalidomide, even if he has undergone a successful vasectomy.
- •Female patients must be in menopause (natural menopause for at least 24 consecutive months, a hysterectomy, or bilateral oophorectomy) to enter the study
- •Karnofsky score > 60% at study entry
- •Patients fitness will be evaluated according to the SIE, SIES and GITMO Guidelines (Ferrara et al, Leukemia 2013)
- •Adequate renal, pulmonary and hepatic function, intended as follows:
- •o Bilirubin = 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
- •o AST and ALT = 3.5 times ULN
- •o Creatinine = 2 times ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
排除标准
- •Acute promyelocytic leukemia (FAB M3)
- •Cytoreduction with hydroxyurea
- •Male and female patients aged <60 years and >70 years
- •Patients with resistant AML who have received more than 2 courses or more of reinduction chemotherapy
- •Blastic transformation of chronic myeloid leukemia
- •Absence of patient’s written informed consent
- •Active opportunistic infections
- •HIV infection
- •Active second malignancy
- •Intercurrent organ damage or medical problems that would interfere with therapy
- •Concurrent therapy for another malignancy
研究者
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