Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study
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|ClinicalTrials.gov Identifier: NCT00715637|
Recruitment Status : Unknown
Verified October 2010 by Antisoma Research.
Recruitment status was: Active, not recruiting
First Posted : July 15, 2008
Last Update Posted : October 13, 2010
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML.
The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.
|Condition or disease||Intervention/treatment||Phase|
|Secondary Acute Myeloid Leukemia (Secondary AML, sAML)||Drug: Daunorubicin and Cytarabine Drug: Amonafide and Cytarabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III 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)- The ACCEDE Study|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||June 2010|
Experimental: Arm A
Amonafide in Combination with Cytarabine
Drug: Amonafide and Cytarabine
Amonafide: 600 mg/m2 IV over 4 hours daily on Days 1-5 (up to max. 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on Days 1-7 (up to max. 2 courses)
Active Comparator: Arm B
Daunorubicin in Combination with Cytarabine
Drug: Daunorubicin and Cytarabine
Daunorubicin: 45 mg/m2 over 30 minutes daily on days 1-3 (up to max. of 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on days 1-7 (up to max. of 2 courses)
- Rate of CR + CRi (which includes CRc and CRd) will be determined by assessing the proportion of patients who achieved CR or CRi among all evaluable patients. [ Time Frame: Course 1/Course 2 Day 37 bone marrow assessments and confirmation bone marrow 30 days later ]
- Median duration of remission and median duration of disease free survival. [ Time Frame: Follow-up visits following post-remission therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715637