Acute Myeloid Leukemia Clinical Trial
Official title:
Phase 2 Open-Label Study of Amonafide L-Malate in Combination With Cytarabine in Subjects With Secondary Acute Myeloid Leukemia (AML)
This protocol is designed to assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML.
Status | Completed |
Enrollment | 80 |
Est. completion date | April 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologic diagnosis of AML (=20% blasts of myeloid lineage in bone marrow), with FAB classification other than M3, secondary to either: 1. Known and documented exposure to prior leukemogenic chemotherapy or radiotherapy, OR 2. Diagnosis of MDS for =3 months prior to study entry (prior BM slides documenting MDS must be available for central pathology review). - Age 18 years or older. - ECOG performance status =2. - No prior induction chemotherapy for AML; at least 4 weeks since completion of prior chemotherapy for MDS. (Subjects with rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic chemotherapy). - Fertile and sexually active men and women must use effective contraception throughout study. Women of childbearing potential must have a negative pregnancy test. - LVEF =50% by MUGA or ECHO. - Adequate renal function: serum creatinine =1.5 x ULN. - Adequate hepatic function: total serum bilirubin =1.5 x ULN as well as serum AST and ALT =1.5 x ULN. - Subject must be able to participate fully in all aspects of the trial. - Subject must give voluntary, written consent and HIPAA authorization (US only). Exclusion Criteria: - Histologic diagnosis of FAB M3 AML (acute promyelocytic leukemia). - Clinically active CNS leukemia. - Known to be HIV positive. - Prior induction chemotherapy for AML. - Known active hepatitis B or C or other active liver disease. - Any major surgery or radiation therapy within 4 weeks prior to study entry. - Prior cytotoxic chemotherapy within 4 weeks prior to study entry.(Subjects with rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic chemotherapy). - Persistent chronic non-hematologic toxicity from prior chemotherapy (other than alopecia) that is > than grade 1. - Serious concomitant illness (e.g., active pulmonary infection, unstable angina or myocardial infarction within 3 months of study entry, congestive heart failure =AHA class 2, stroke within 3 months prior to study entry, uncontrolled hypertension, uncontrolled diabetes, actively bleeding gastric ulcer, etc.). - Women who are pregnant or lactating. - History of clinically significant allergic reactions attributed to compounds similar to amonafide or cytarabine. - Prior enrollment on this trial. - Any other known condition (familial, sociological, or geographic) or behavior (including substance abuse, psychological or psychiatric illness), which in the investigator's opinion would make the subject a poor candidate for this trial. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | London Regional Cancer Program, London Health Science Center | London | Ontario |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Colorado Health Sciences Center, Anschutz Cancer Center | Aurora | Colorado |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | MUSC - Hollings Cancer Center | Charleston | South Carolina |
United States | Northwestern University, Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois |
United States | Baylor University Medical Center | Dallas | Texas |
United States | City of Hope National Medical Center | Duarte | California |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of Florida Health Science Center | Gainesville | Florida |
United States | St. Francis Cancer Research Foundation (formerly Indiana Oncology Hematology Consultants and American Health Network of Indiana LLC, Oncology Division) | Indianapolis | Indiana |
United States | UCLA Medical Center | Los Angeles | California |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | West Virginia University Medical Center | Morgantown | West Virginia |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Scripps Cancer Center | San Diego | California |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
United States | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Xanthus Pharmaceuticals, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | - To determine the rate of complete remission with or without complete hematopoietic recovery (CR + CRi). | |||
Secondary | Determine the median duration of complete remission with or without complete hematopoietic recovery (CR or CRi) | |||
Secondary | Determine the proportion of subjects remaining in complete remission (CR +CRi) at 6 months, at 12 months and at 18 months | |||
Secondary | Determine the median duration of overall survival (OS) | |||
Secondary | Correlate clinical responses and duration of responses with specific cytogenetic abnormalities | |||
Secondary | Define the population pharmacokinetic (PK) profile of amonafide and its metabolites when administered as an intravenous infusion daily x 5 days in combination with a standard-dose of cytarabine | |||
Secondary | Define the safety profile and confirm the acceptability of amonafide and cytarabine | |||
Secondary | Correlate PK exposure of amonafide and acetylation of amonafide with safety and efficacy assessments in individual subjects |
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