Amonafide in Combination With Cytarabine in Secondary AML

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

This protocol is designed to assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML.

Key facts

Study ID

NCT00273884

Run by

Xanthus Pharmaceuticals, Inc.

People needed

80

Starts

2005-08-01

Expected to finish

2009-04-01

Last updated by the study team

2007-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic diagnosis of AML (≥20% blasts of myeloid lineage in bone marrow), with FAB classification other than M3, secondary to either:
• Known and documented exposure to prior leukemogenic chemotherapy or radiotherapy, OR
• 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).

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Scripps Cancer Center — San Diego, California, United States
• University of Colorado Health Sciences Center, Anschutz Cancer Center — Aurora, Colorado, United States
• University of Florida Health Science Center — Gainesville, Florida, United States
• Northwestern University, Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, 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
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• MUSC - Hollings Cancer Center — Charleston, South Carolina, United States
• Baylor University Medical Center — Dallas, Texas, United States
• West Virginia University Medical Center — Morgantown, West Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• London Regional Cancer Program, London Health Science Center — London, Ontario, Canada

Full record on ClinicalTrials.gov

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