Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
An Open-Label, Single-Arm, Multi-Center, Phase II Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia (AML) in Second Salvage
1 other identifier
interventional
211
1 country
20
Brief Summary
This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2005
20 active sites
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
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 10, 2005
CompletedFirst Posted
Study publicly available on registry
August 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedNovember 3, 2006
November 1, 2006
August 10, 2005
November 1, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine complete response (CR) rate
Secondary Outcomes (2)
To determine the complete response with incomplete platelet recovery (CRp) rate, and recurrent disease (RD) rates
Efficacy and safety, preliminary evidence of the anti-tumor activity, determination of Troxatyl™ infusion pharmacokinetic parameters
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of acute myeloid leukemia (AML) in the second salvage setting: refractory to two prior courses of therapy or primary refractory without response to two previous courses of leukemia therapy.
- Patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.
- Patients who are in second relapse, must have had a duration of their second CR or CRp of less than six months.
- Subjects must have adequate organ and immune function as indicated by the following laboratory values:
- Creatinine clearance ≥ 45 mL/min and ≤ 125 mL/min;
- Total bilirubin ≤ 2.0 mg/dL (≤ 34.2 µmol/L);
- AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN).
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of \< 2, and an estimated life expectancy of at least eight weeks.
You may not qualify if:
- Clinical evidence of active central nervous system (CNS) leukemic involvement
- Active and uncontrolled infection
- Uncontrolled medical problems unrelated to the malignancy that impair patient ability to give informed consent or unacceptably reduce the safety of the proposed treatment
- Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
- Known or suspected intolerance or hypersensitivity to Troxatyl® or closely related compounds such as lamivudine or any of the stated ingredients
- A recent history of alcohol or other substance abuse
- Subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrolment
- Females with a positive pregnancy test at screening
- Subjects who have previously been enrolled into this study and subsequently withdrew
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Scripps Clinic
La Jolla, California, 92037, United States
USC-Norris Neuro-Oncology Program
Los Angeles, California, 90033, United States
UCSD Moores Cancer Center
San Diego, California, 92093, United States
Univ. of Florida, Baptist Cancer Center
Jacksonville, Florida, 32209, United States
Winship Cancer Institute, Emory University Hosp.
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Harper Hospital - Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Univ. of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
New York Presbyterian Hospital-Cornell Campus
New York, New York, 10021, United States
Wake Forest Univ. School of Medicine
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Univ. of South Carolina, Hematology/Oncology Division
Charleston, South Carolina, 29425, United States
Univ. of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Morgantown Internal Medicine Group
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis Giles, MD
M.D. Anderson Cancer Center
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
August 10, 2005
First Posted
August 12, 2005
Study Start
July 1, 2005
Study Completion
October 1, 2007
Last Updated
November 3, 2006
Record last verified: 2006-11