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| Sponsor: | Antisoma Research |
|---|---|
| Information provided by: | Antisoma Research |
| ClinicalTrials.gov Identifier: | NCT00715637 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Secondary Acute Myeloid Leukemia (Secondary AML, sAML) |
Drug: Daunorubicin and Cytarabine Drug: Amonafide and Cytarabine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 450 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm A: Experimental
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)
|
|
Arm B: Active Comparator
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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bill Lundberg, MD | 617-225-0522 ext 164 | bill.lundberg@antisoma.com |
Show 138 Study Locations
More Information
| Responsible Party: | Antisoma ( J. Kris Piper, VP Regulatory Affairs ) |
| Study ID Numbers: | 509912 |
| Study First Received: | July 14, 2008 |
| Last Updated: | December 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00715637 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AML Leukemia MDS Amonafide |
Cytarabine Daunorubicin Lymphatic disorders |
|
Antimetabolites Anti-Infective Agents Daunorubicin Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Leukemia, Myeloid Antibiotics, Antineoplastic |
Leukemia, Myeloid, Acute Amonafide Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Leukemia Neoplasms Neoplastic Processes Pathologic Processes Therapeutic Uses Neoplasm Metastasis Cytarabine |