|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | 420 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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
Show 158 Study Locations
More Information
| Responsible Party: | Bina Tejura/Medical Director, Antisoma |
| ClinicalTrials.gov Identifier: | NCT00715637 History of Changes |
| Obsolete Identifiers: | NCT00509912 |
| Other Study ID Numbers: | 509912 |
| Study First Received: | July 14, 2008 |
| Last Updated: | October 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
AML Leukemia MDS Amonafide |
Cytarabine Daunorubicin Lymphatic disorders |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Amonafide Daunorubicin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Enzyme Inhibitors |