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| Sponsor: | MedImmune LLC |
|---|---|
| Information provided by: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00086099 |
Purpose
The primary objectives of this study are:
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Acute Myeloid Leukemia |
Drug: Idarubincin and Amufostine (Ethyol) Drug: Idarubincin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase IB/II, Randomized, Open-Label, Multicenter Study Evaluating Whether the Addition of Amifostine (Ethyol®) Will Enable the Safe Increase in Dose Intensity of Idarubicin in Combination With Cytosine Arabinoside in Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia |
| Enrollment: | 54 |
| Study Start Date: | July 2004 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Idarubicin plus amifostine
|
Drug: Idarubincin and Amufostine (Ethyol)
Starting doses of Idarubincin(12,18 mg/m2 to 21 mg/m2), ara-C, plus amofostine (N-36)
|
|
2: Experimental
Idarubincin
|
Drug: Idarubincin
Idarubincin (12mg/m2) and ara-C(N-18)
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Scripps Cancer Center | |
| San Diego, California, United States, 92121 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Cancer Care Center | |
| New Albany, Indiana, United States, 47150 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Michigan | |
| Cancer Management Specialists (No longer Recruiting) | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Spectrum Health Hospitals-Cook Research Dept. (No longer recruiting) | |
| Grand Rapids, Michigan, United States, 49503 | |
| Great Lakes Cancer Center Management Specialties | |
| Grosse Point Woods, Michigan, United States, 48236 | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| United States, New Jersey | |
| St. Barnabas Health Care Center | |
| Newark, New Jersey, United States, 07112 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| United States, North Carolina | |
| Wake Forest University School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, Ohio | |
| Cleveland Clinic Foundation-Hemoatology/Oncology | |
| Cleveland, Ohio, United States, 44195-001 | |
| United States, Pennsylvania | |
| Thomas Jefferson University Medical College | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Tennessee | |
| Baptist Clinical Research Center | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Israel | |
| Kaplan Med. Center | |
| Rehovot, Israel, 76100 | |
| Rabin Medical Center | |
| Petach Tikva, Israel, 49100 | |
| Sheba Medical Center | |
| Tel Hasomer, Israel, 52620 | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Study Director: | Dirk J. Reitsma, M.D. | MedImmune LLC |
More Information
| Responsible Party: | MedImmune LLC ( Dirk J. Reitsma, M.D. ) |
| Study ID Numbers: | MI-CP103 |
| Study First Received: | June 23, 2004 |
| Last Updated: | January 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00086099 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Anti-Infective Agents Radiation-Protective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Amifostine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid |
Antibiotics, Antineoplastic Leukemia, Myeloid, Acute Protective Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Leukemia Neoplasms Idarubicin Therapeutic Uses Cytarabine |