NCT00273884

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2005

Typical duration for phase_2

Geographic Reach
2 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

February 19, 2007

Status Verified

February 1, 2007

First QC Date

January 5, 2006

Last Update Submit

February 16, 2007

Conditions

Acute Myeloid Leukemia

Keywords

AMLSecondary AMLLeukemia

Outcome Measures

Primary Outcomes (1)

  • - To determine the rate of complete remission with or without complete hematopoietic recovery (CR + CRi).

Secondary Outcomes (7)

  • Determine the median duration of complete remission with or without complete hematopoietic recovery (CR or CRi)

  • Determine the proportion of subjects remaining in complete remission (CR +CRi) at 6 months, at 12 months and at 18 months

  • Determine the median duration of overall survival (OS)

  • Correlate clinical responses and duration of responses with specific cytogenetic abnormalities

  • Define the population pharmacokinetic (PK) profile of amonafide and its metabolites when administered as an intravenous infusion daily x 5 days in combination with a standard-dose of cytarabine

  • +2 more secondary outcomes

Interventions

Amonafide L-MalateDRUG
CytarabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

UCLA Medical Center

Los Angeles, California, 90024, United States

Location

Scripps Cancer Center

San Diego, California, 92121, United States

Location

University of Colorado Health Sciences Center, Anschutz Cancer Center

Aurora, Colorado, 80010, United States

Location

University of Florida Health Science Center

Gainesville, Florida, 32610-0277, United States

Location

Northwestern University, Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

St. Francis Cancer Research Foundation (formerly Indiana Oncology Hematology Consultants and American Health Network of Indiana LLC, Oncology Division)

Indianapolis, Indiana, 46202, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-0848, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 98198 7835, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 75246, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MUSC - Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

West Virginia University Medical Center

Morgantown, West Virginia, 26506-9162, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E3, Canada

Location

London Regional Cancer Program, London Health Science Center

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemia

Interventions

xanafideCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Steven Allen, MD

    North Shore Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

August 1, 2005

Study Completion

April 1, 2009

Last Updated

February 19, 2007

Record last verified: 2007-02

Locations

CA(2)US(19)