Phase I trials of amonafide as monotherapy and in combination with cytarabine in patients with poor-risk acute myeloid leukemia

Abstract Amonafide- l -malate (amonafide) is a unique DNA intercalator that maintains activity in the presence of MDR mechanisms, a frequent cause of treatment-failure in secondary AML. 43 patients with relapsed/refractory or secondary AML or CML blast crisis were enrolled into two phase I dose-esca...

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Bibliographic Details
Published in:Leukemia research 2010-04, Vol.34 (4), p.487-491
Main Authors: Allen, Steven L, Kolitz, Jonathan E, Lundberg, Ante S, Bennett, John M, Capizzi, Robert L, Budman, Daniel R
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
AML
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cytarabine - administration & dosage
Cytarabine - adverse effects
Female
Hematology, Oncology and Palliative Medicine
Humans
Leukemia, Myeloid, Acute - drug therapy
Male
Middle Aged
Multidrug resistance
Naphthalimides - administration & dosage
Naphthalimides - adverse effects
P-glycoprotein
Pgp
Phase I
Remission Induction
Risk Factors
Treatment Outcome
Young Adult
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Summary:Abstract Amonafide- l -malate (amonafide) is a unique DNA intercalator that maintains activity in the presence of MDR mechanisms, a frequent cause of treatment-failure in secondary AML. 43 patients with relapsed/refractory or secondary AML or CML blast crisis were enrolled into two phase I dose-escalation studies investigating amonafide as monotherapy or in combination with cytarabine. 3/17 patients in the monotherapy trial and 10/26 patients in the combination trial achieved a complete remission. Between both trials responses occurred in 9/20 patients with secondary AML. Both trials demonstrated an acceptable safety profile and significant antileukemic activity in patients with poor-risk AML, especially those with secondary AML.
ISSN:0145-2126
1873-5835
DOI:10.1016/j.leukres.2009.07.038