Phase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination with Cytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML) - ACCEDE
- Conditions
- -C920 Acute myeloblastic leukaemia [AML]Acute myeloblastic leukaemia [AML]C920
- Registration Number
- PER-068-09
- Lead Sponsor
- Antisoma Research Ltd.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Diagnosis of AML according to the WHO37 diagnostic criteria (at least 20% of blasts in peripheral blood or bone marrow), with a FAB classification other than M3 (Acute Promyelocytic Leukemia), documented by bone marrow aspiration and biopsy Bone performed within 14 days before administration of the P dose of remission induction chemotherapy.
• Age: 18 years or older;
• ECOG functional status classification <2;
• Sexually active fertile patients (men and women) should use an effective method of contraception that should be continued throughout the study.
• Women of childbearing age should have a negative serum pregnancy test. A fertile woman is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose partners are either sterile or are using contraceptives
• The Left Ventricular Ejection Fraction (LVEF)> 50%, as determined by MUGA whether or echocardiogram (ECHO) within 14 days prior to the administration of the 1® dose of remission induction chemotherapy.
• Adequate renal function as evidenced in the following laboratory tests, obtained within 14 days prior to administration of the I® dose of remission induction chemotherapy: serum creatinine <1.5 x ULN;
• Adequate liver function as evidenced in the following laboratory tests, obtained within 14 days prior to administration of the 1® dose of remission induction chemotherapy (unless attributed to hepatic involvement with AML): Serum bilirubin total <1.5 x ULN; Serum AST and ALT <1.5 x ULN;
• Patient´s ability to participate fully in all aspects of this clinical trial;
• Written Informed Consent and authorization from HIPAA (US centers only) must be obtained and documented.
• Histological diagnosis of FAB M3, Acute Promyelocytic Leukemia;
• Clinically active CNS leukemia;
• Previous induction therapy for AML;
• HIV positive known;
• Known active hepatitis B or C or any other active liver disease;
• Evidence of lung infection. Patients with parenchymal abnormality on the chest radiograph at the time of selection should undergo a computed tomography (CT) of the chest prior to the start of remission induction therapy to confirm the absence or presence of lung infection.
• Any major surgery or radiation therapy within 4 weeks prior to admission to the study;
• Previous cytotoxic chemotherapy for MDS within 4 weeks prior to admission to the study (patients with rapidly increasing blast count may enroll within 4 weeks of prior cytotoxic chemotherapy if discussed with the Medical Monitor);
• Persistent chronic non-hematologic toxicity (other than alopecia) of degree greater than 1 since previous therapy for MDS;
• Serious concomitant diseases (for example, pulmonary infiltration, unstable angina pectoris or myocardial infarction or stroke within 3 months prior to study entry, congestive heart failure class 2 of AHA or greater, uncontrolled hypertension, uncontrolled diabetes, actively bleeding gastric ulcer, etc.), which in the opinion of the researcher would not consider the patient as a good candidate for the trial;
• Pregnant or breastfeeding woman;
• History of clinically significant allergic reactions attributed to ingredients of chemical or biological composition similar to amonafide, cytarabine or daunorubicin;
• Prior enrollment in this trial;
• Any other condition (for example, family, sociological or geographical) or conduct (including dependence or substance abuse, psychological or psychiatric illness) that, in the opinion of the investigator, would not consider the patient as a good candidate for the trial;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method