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Amonafide in Combination With Cytarabine in Secondary AML | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Amonafide in Combination With Cytarabine in Secondary AML

Phase 2 Open-Label Study of Amonafide L-Malate in Combination With Cytarabine in Subjects With Secondary Acute Myeloid Leukemia (AML)

NCT00273884•Xanthus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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 and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. In three phase I clinical trials, amonafide demonstrated anti-leukemic activity, both as monotherapy and in combination with cytarabine. This protocol is designed to further assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML. The duration of the study is approximately 42 months: enrollment approximately 18 months and subject duration up to 24 months

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.
+3 more criteria

Locations (21)

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

Key Dates

Start Date

August 1, 2005

Completion Date

April 1, 2009

Last Updated

February 19, 2007

Enrollment

Estimated participants

Conditions

Acute Myeloid Leukemia

Interventions

Amonafide L-Malate

DRUG

Cytarabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Amonafide in Combination With Cytarabine in Secondary AML

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias