EUCTR2007-004427-38-ES进行中（未招募）不适用
Estudio abierto y aleatorizado en fase 3 de L-malato de amonafida en combinación con citarabina comparado con daunorrubicina en combinación con citarabina en pacientes con leucemia mieloide aguda (LMA) secundariaPhase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination withCytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 420
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
- •a.) Diagnosis of AML according to WHO diagnostic criteria (at least 20% blasts in the peripheral blood or bone marrow), with FAB classification other than M3 (Acute
- •Promyelocytic Leukemia), documented by bone marrow aspiration and biopsy
- •performed within 14 days prior to administration of 1st dose of remission induction
- •chemotherapy;
- •a. Known and documented exposure to specific leukemogenic therapy of a specified nature for a non-myeloid condition.
- •b. Documented diagnosis of MDS or chronic myelomonocytic leukemia (CMML) according to WHO criteria for at least 3 months prior to study entry, with prior bone marrow aspirate, biopsy and peripheral blood smear documenting MDS available to be submitted for subsequent central pathology review.
- •c.) Age 18 years or older;
- •d.) Eastern Cooperative Oncology Group (ECOG) performance score ? 2;
- •e.) Fertile sexually active patients (men and women) must use an effective method of
- •contraception which must be continued throughout the study.
- •f.) Women of childbearing potential must have a negative serum pregnancy test. A
- •woman of childbearing potential is defined as one who is biologically capable of
- •becoming pregnant. This includes women who are using contraceptives or whose
- •sexual partners are either sterile or using contraceptives;
- •g.) Left Ventricular Ejection Fraction (LVEF) ? 50%, as determined by multiple-gated
- •acquisition scan (MUGA) or echocardiogram (ECHO) within 14 days prior to
- •administration of 1st dose of remission induction chemotherapy;
- •h.) Adequate renal function as evidenced by the following laboratory test, obtained
- •within 14 days prior to administration of 1st dose of remission induction
- •chemotherapy:
- •?Serum creatinine ? 1.5 x ULN;
- •i.) Adequate hepatic function as evidenced by the following laboratory tests, obtained within 14 days prior to administration of 1st dose of remission induction
- •chemotherapy (unless attributed to hepatic involvement with AML):
- •?Total serum bilirubin ? 1.5 x ULN;
- •?Serum AST and ALT ? 1.5 x ULN;
- •j.) Ability of the patient to participate fully in all aspects of this clinical trial;
- •k.) Written Informed Consent and HIPAA authorization (USA sites only) must be
- •obtained and documented.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a.) Histologic diagnosis of FAB M3 Acute Promyelocytic Leukemia;
- •b.) Clinically active CNS leukemia;
- •c.) Prior induction therapy for AML;
- •d.) Known HIV positive;
- •e.) Known active hepatitis B or C, or any other active liver disease;
- •f.) Patients with parenchymal abnormality on screening chest x-ray must have no
- •evidence of pulmonary infection on chest tomography (CT) prior to starting remission
- •induction therapy.
- •g.) Any major surgery or radiation therapy within 4 weeks prior to study entry;
- •h.) Prior cytotoxic chemotherapy for MDS within 4 weeks prior to study entry (patients with rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic chemotherapy with waiver from the Medical Monitor);
- •i.) Persistent chronic non-hematologic toxicity (other than alopecia) greater than grade 1 from prior therapy for MDS;
- •j.) Serious concomitant illnesses (for example, pulmonary infiltrate, unstable angina or myocardial infarction or stroke within 3 months prior to study entry, congestive heart failure AHA class 2 or greater, uncontrolled hypertension, uncontrolled diabetes, actively bleeding gastric ulcer, etc.), which in the investigator?s opinion would not make the patient a good candidate for the trial;
- •k.) Pregnant or breast feeding;
- •l.) History of clinically significant allergic reactions attributed to compounds of similar
- •chemical or biological composition to amonafide, cytarabine or daunorubicin;
- •m.) Prior enrollment in this trial;
- •n.) Any other known condition (e.g., familial, sociological, or geographical) or behavior
- •(including substance dependence or abuse, psychological or psychiatric illness), which in the investigator?s opinion would make the patient a poor candidate for the
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