None listed
Conditions
Interventions
Group 1 Type of group
L-malate of amonafide in combination with cytarabine. Cytarabine will be administered at a dose of 200 mg / mi / day by continuous IV infusion for 7 consecutive days beginning Course 1 and, if applicable, Course 2, Day 1 using a constant infusion device. The infusion should not be interrupted. The cytarabine will be administered in accordance with the centers standard policies and procedures. Amonafide will be administered at a dose of 600 mg / nn / day by IV infusion for 4 hours for 5 consecuti
Cytarabine will be administered at a dose of 200 mg / m2 / day by continuous IV infusion for 7 consecutive days beginning Course 1 and, if applicable, Course 2, Day 1 using a constant infusion device. The infusion should not be interrupted. The cytarabine will be administered in accordance with the centers standard policies and procedures. Daunorubicin will be administered at a dose of 45 mg / m2 / day by IV infusion for 30 minutes for 3 consecutive days beginning Course 1 and, if applicable, Co
Sponsors
Antisoma Research Ltd.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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 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.
Exclusion criteria
Exclusion criteria: • 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It will be determined by evaluating the proportion of patients who achieved confirmed CR or CRi among all evaluable patients. Confirmed CR or CRi is defined as the documentation of CR or CRi at least 30 days after the initial determination of CR or CRi after post remission therapy or immediately before post remission therapy if such therapy is performed within 30 days from the initial determination of CR or CRi. Measure:Variation in the CR + CRi index confirmed Timepoints:30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Variation in the Will be determined when evaluating the proportion of patients who respond (CR, CRi or PR) .global response (CR + CRi + PR) Measure:Variation in the overall response rate (CR + CRi + PR) Timepoints:During the study ; Outcome name:It will be determined by evaluating the proportion of patients who have achieved the indicated response. Measure:Response rate for each individual response category (CR, CRi, CRc, CRd and PR) Timepoints:During the study ; Outcome name:Will be calculated as the median duration from the date of remission until the next relapse. For patients who die and have not attended the visit immediately prior to death, the duration of remission will be calculated from the date of remission to the date of death. Measure:Duration of remission for all patients in remission and for each category of individual response (CR, CRi, CRc, CRd and PR) Timepoints:During the study ; Outcome name:It will be calculated as the median duration from the date of remission to subsequent relapse or death for the population of patients who have achieved remission or will be suppressed on the last known date they were alive and without relapse; Measure:Disease-free survival (DFS) Timepoints:During the study ; Outcome name:It will be calculated as the duration of survival from the date of randomization to the study until death due to any cause or it will be suppressed on the date it was learned that the patient was alive. Measure:Overall Survival (OS) Timepoints:During the study | — |
Countries
Austria, Czech Republic, Estonia, France, Germany, Greece, Hungary, Italy, Peru, Spain, United Kindgdom
Contacts
Public ContactMariana Abdala
PSI CRO Peru S.A.C.
Outcome results
None listed