Status:
COMPLETED
Amonafide in Combination With Cytarabine in Secondary AML
Lead Sponsor:
Xanthus Pharmaceuticals, Inc.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This protocol is designed to assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML.
Detailed Description
This is a two-stage, open-label, phase 2, multicenter study of amonafide L-malate in combination with standard-dose cytarabine in subjects with secondary AML. Amonafide is a DNA intercalating agent a...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00273884
Start Date
August 1 2005
End Date
April 1 2009
Last Update
February 19 2007
Active Locations (21)
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1
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
UCLA Medical Center
Los Angeles, California, United States, 90024
4
Scripps Cancer Center
San Diego, California, United States, 92121