Amonafide in Combination With Cytarabine in Secondary AML

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xanthus Pharmaceuticals, Inc.
• Treatments: Amonafide; Cytarabine

Criteria

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.