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Sponsors and Collaborators: |
ChemGenex Pharmaceuticals Stragen France |
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Information provided by: | ChemGenex Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00462943 |
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 |
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 |
Estimated Enrollment: | 81 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2010 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eric Humphriss | 800-877-3009 ext 112 | ehumphriss@chemgenex.com |
Contact: Adam Craig, M.D. | 800-877-3009 ext 121 | acraig@chemgenex.com |
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. |
Principal Investigator: | Jorge Cortes, MD | M.D. Anderson Cancer Center |
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 |
CML HHT Homoharringtonine Ceflatonin |
Leukemia Chronic myelogenous leukemia Hematologic Diseases Homoharringtonine Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases Harringtonines |
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 |