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Open Label Study of Subcutaneous Homoharringtonine in Patients With Advanced CML
This study is currently recruiting participants.
Verified by ChemGenex Pharmaceuticals, April 2007
Sponsors and Collaborators: ChemGenex Pharmaceuticals
Stragen France
Information provided by: ChemGenex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00462943
  Purpose

A Phase II open-label trial of subcutaneous HHT in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.


Condition Intervention Phase
Chronic Myelogenous Leukemia
Drug: Homoharringtonine
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Tyrosine Homoharringtonine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Patients With Chronic Myeloid Leukemia (CML) Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy

Further study details as provided by ChemGenex Pharmaceuticals:

Primary Outcome Measures:
  • Clinical Response

Secondary Outcome Measures:
  • Degree of Hematologic Response
  • Time to Response
  • Time to progression
  • Survival

Estimated Enrollment: 81
Study Start Date: February 2007
Estimated Study Completion Date: February 2010
Detailed Description:

This will be an open label, multicenter study of subcutaneous HHT therapy of patients with chronic myeloid leukemia (CML) in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy. Patients will be treated with induction course cycles consisting of subcutaneous (SC) HHT 1.25 mg/m² twice daily for 14 consecutive days every 28 days. Patients will be evaluated every 7 days with complete blood and platelet counts while undergoing induction therapy; the number of consecutive doses of HHT or intervals between subsequent cycles may be adjusted, as clinically indicated, according to guidelines provided in the treatment plan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients, age 18 years or older
  • Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase
  • Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two tyrosine kinase inhibitors (TKI's). Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response).
  • Acceptable Renal and Liver Function
  • ECOG performance status 0-2.
  • Sexually active patients and their partners must use an effective double barrier method of contraception

Exclusion Criteria:

  • NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition
  • Myocardial infarction in the previous 12 weeks.
  • Other concurrent illness which would preclude study conduct and assessment
  • uncontrolled and active infection, and positive HIV or positive HTLV I/II status, whether on treatment or not.
  • Pregnant or lactating.
  • Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.
  • Lymphoid Ph+ blast crisis
  • Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462943

Contacts
Contact: Eric Humphriss 800-877-3009 ext 112 ehumphriss@chemgenex.com
Contact: Adam Craig, M.D. 800-877-3009 ext 121 acraig@chemgenex.com

Locations
United States, California
USC/Norris Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Dan Douer, M.D.     323-865-3950     douer_d@ccnt.hsc.usc.edu    
Contact: Kristy Watkins, R.N.     323-865-0452     Watkins_K@ccnt.hsc.usc.edu    
Principal Investigator: Dan Douer, M.D.            
United States, Indiana
Indiana Bone Marrow Transplant Center Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Luke Akard, M.D.     317-865-5500     lakard@ibmtindy.com    
Contact: Jean Lonergan, R.N.     317-782-7298     jlonergan@ibmtindy.com    
Principal Investigator: Luke Akard, M.D.            
United States, Maryland
University of Maryland Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Maria Baer, M.D.     410-328-9161     mbaer@umm.edu    
Contact: Shannon Decker     410-328-9161     sdecker@umm.edu    
Principal Investigator: Maria Baer, M.D.            
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Meir Wetzler, M.D.     716-845-8447     meir.wetzler@roswellpark.org    
Contact: Laurie Ford     716-845-8360     LaurieAnn.Ford@RoswellPark.org    
Principal Investigator: Meir Wetzler, M.D.            
Our Lady Mercy Cancer Center Recruiting
Bronx, New York, United States, 10466
Contact: Peter Wiernik, M.D.     718-304-7220     pwiernik@aol.com    
Contact: Suzy Graham     718-920-9021     sgraham@olmhs.org    
Principal Investigator: Peter Wiernik, M.D.            
United States, Pennsylvania
Fox Chase Temple BMT Program Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Robert Emmons, M.D.     215-214-3125     Robert.Emmons@tuhs.temple.edu    
Principal Investigator: Robert Emmons, M.D.            
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 70030
Contact: Rochelle Allen, R.N.     713-745-8749     rdallen@mdanderson.org    
Contact: Rachel Abramowicz     713-745-3415     rrabramo@mdanderson.org    
Principal Investigator: Jorge Cortes, MD            
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Jeffery Lipton, M.D.     416-946-2268     Jeff.Lipton@uhn.on.ca    
Contact: Sima Bogomilsky     416-946-4646        
Principal Investigator: Jeffery Lipton, M.D.            
Sponsors and Collaborators
ChemGenex Pharmaceuticals
Stragen France
Investigators
Principal Investigator: Jorge Cortes, MD M.D. Anderson Cancer Center
  More Information

Study ID Numbers: CGX-635-CML-203
Study First Received: April 17, 2007
Last Updated: November 26, 2007
ClinicalTrials.gov Identifier: NCT00462943  
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada;   Europe: European Medicines Evaluation Agency;   United Kingdom: Medicines Control Agency

Keywords provided by ChemGenex Pharmaceuticals:
CML
HHT
Homoharringtonine
Ceflatonin

Study placed in the following topic categories:
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Homoharringtonine
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Harringtonines

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009