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Sponsors and Collaborators: |
ChemGenex Pharmaceuticals Stragen France |
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Information provided by: | ChemGenex Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00375219 |
To evaluate the safety and efficacy of subcutaneous administration of homoharringtonine (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.
Condition | Intervention | Phase |
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Myeloid Leukemia, Chronic Myeloid Leukemia, Chronic, Accelerated-Phase Blast Phase Myeloid Leukemia, Chronic, Chronic-Phase |
Drug: Homoharringtonine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine in the Treatment of Patients With Chronic Myeloid Leukemia (CML) With T315I BCR-ABL Gene Mutation |
Estimated Enrollment: | 81 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | July 2009 |
Point mutations within the ABL kinase domain of the BCR-ABL gene are emerging as the most frequent mechanism for resistance to imatinib and resultant reactivation of kinase activity. The risk of mutation development is particularly high in patients who are beyond chronic phase, as well as those with a long duration of disease prior to imatinib therapy.
The T315I kinase domain (KD) point mutation has merited particular attention, as T315I expressing CML cells are markedly resistant to imatinib. CML patients with the T315I KD mutation, therefore, do not respond to continued treatment with imatinib, and preliminary clinical data indicate that neither of two newer tyrosine kinase inhibitors will have activity in patients with T315I KD mutation either. Homoharringtonine (HHT) is a potent inducer of apoptosis (programmed cell death) in myeloid cells and inhibits angiogenesis (blood vessel formation). In Phase 2 studies, HHT has demonstrated clinical activity in patients with CML, both as a single agent and in-combination with other chemotherapeutic drugs. HHT works via a different mechanism than imatinib or other tyrosine kinase inhibitors (TKI's), and HHT has been shown to inhibit in vitro CML cell lines which harbor the T315I KD mutation and are highly resistant to imatinib. Therefore, CML patients who have the T315I KD mutation may still respond to treatment with HHT. HHT may therefore be an attractive therapeutic option for patients with the T315I KD mutation. On this basis, a multicenter clinical trial is being conducted of HHT therapy for CML patients who have failed prior imatinib therapy and have the T315I KD mutation. Patients will be treated with an induction course consisting of subcutaneous (SC) HHT twice daily for 14 consecutive days every 28 days. Patients who demonstrate a response, may receive maintenance therapy for up to 24 months, consisting of subcutaneous (SC) HHT twice daily for 7 days every 28 days.
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, 90025 | |
Contact: Kristy Watkins, RN 323-865-0452 watkins_K@ccnt.hsc.usc.edu | |
Contact: Vicky Soto 323-865-0575 soto@ccnt.esc.edu | |
Principal Investigator: Dan Douer, MD | |
United States, Florida | |
Mayo Clinic - Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Tosia McCready, RN 904-953-2191 | |
Principal Investigator: Candido Rivera, MD | |
United States, Georgia | |
Emory University School of Medicine | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Kristy Etris 404-778-4582 kristy.etris@emoryhealthcare.org | |
Contact: Chizoba Ezekwem 404-778-5319 Chizoba.Ezekwem@emoryhealth.org | |
Principal Investigator: H. Jean Khoury, MD, FACP | |
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 M. Lonergan, R.N. 317-782-7298 jlonergan@ibmtindy.com | |
Principal Investigator: Luke Akard, M.D. | |
United States, Massachusetts | |
Tufts University | Recruiting |
Boston, Massachusetts, United States, 02111 | |
Contact: Julie Burt 617-636-2883 JBurt@tufts-nemc.org | |
Principal Investigator: Richard A Van Etten, MD, PhD | |
United States, New York | |
Our Lady of Mercy Medical Center | Recruiting |
Bronx, New York, United States, 10466 | |
Contact: Peter Wiernik, MD 718-304-7200 pwiernik@aol.com | |
Principal Investigator: Peter Wiernik, MD | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263 | |
Contact: Laurie Ford 716-845-8360 laurieann.ford@roswellpark.org | |
Principal Investigator: Meir Wetzler, MD | |
United States, Pennsylvania | |
Fox Chase-Temple BMT | 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 | |
M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77210-4390 | |
Contact: Jorge Cortes, MD 800-392-1611 | |
Principal Investigator: Jorge Cortes, MD | |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada | |
Contact: Sima Bogomilsky 416-946-4646 sima.bogomilsky@uhn.on.ca | |
Principal Investigator: Jeffery Lipton, M.D. | |
France | |
Hopital Edouard Herriot | Recruiting |
Lyon, France | |
Contact: Elodie Gadolet +33(0)4 72 11 73 01 elodie.gadolet@chu-lyon.fr | |
Principal Investigator: Mauricette Michallet, MD | |
Hopital A. Mignot | Recruiting |
Le Chesnay, France | |
Contact: Estelle Henry +33 (0)1 39 63 80 05 ehenry@ch-versailles.fr | |
Principal Investigator: Philippe Rousselot, MD | |
Hopital Claude Huriez | Recruiting |
Lille, France | |
Contact: Marie-Odile Petillon, MD 33 3 20 44 42 84 mo-petillon@chru-lille.fr | |
Principal Investigator: Thierry Facon, MD | |
Poitiers University Hospital | Recruiting |
Poitiers, France, 86021 | |
Contact: Elodie Rogeon 33 5 49 44 46 89 crc@chu-poitiers.fr | |
Principal Investigator: Francois Guilhot, MD | |
CHU Brabois Service Hematologie Et Medecine Interne | Recruiting |
Vandoeuvre, France | |
Contact: Agnes Guerci-Bresler, M.D. +33 3 83 15 32 81 a.guerci@chu-nancy.fr | |
Principal Investigator: Agnes Guerci-Bresler, M.D. | |
Hopital Archet | Recruiting |
Nice, France | |
Contact: Erit Touiti +33 4 92 03 90 87 touitou.i@chu-nice.fr | |
Principal Investigator: Laurence Legros, M.D. | |
Germany | |
Fakultat fur Klinische Medzin Mannheim der Universitat Heidelberg | Recruiting |
Mannheim, Germany | |
Contact: Elke Matzat +49-621/383-4182 elke.matzat@med3.ma.uni-heidelberg.de | |
Principal Investigator: Andreas Hochhaus, MD Prof Dr | |
Charite-Universitatsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Hamatologie and Onkologie CVK | Recruiting |
Berlin, Germany | |
Contact: Philippe Le Coutre, M.D. ++49 (0) 30450553065 philipp.lecoutre@charite.de | |
Principal Investigator: Philippe Le Coutre, M.D. | |
United Kingdom | |
Clinical Trials Unit, 2nd Floor, Catherine Lewis Centre, Hammersmith Hospital | Recruiting |
London, United Kingdom, W12 OHS | |
Contact: David Marin, M.D. 020 8383 1627 d.marin@imperial.ac.uk | |
Contact: Lorraine Armstrong 020 8383 8553 armstrong@imperial.ac.uk | |
Principal Investigator: David Marin, M.D. |
Principal Investigator: | Jorge Cortes, MD | Univ. of Texas M.D. Anderson Cancer Center |
Principal Investigator: | Andreas Hochhaus, MD Prof Dr | Mannheim der Universitat Heidelberg |
Study ID Numbers: | CGX-635-CML-202 |
Study First Received: | September 8, 2006 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00375219 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukemia Myeloid Leukemia Chronic Phase Accelerated Phase Blast Phase |
Leukemia, Myeloid, Accelerated-Phase Myeloid, Leukemia, Chronic, Chronic Phase ChemGenex ChemGenex Pharmaceuticals |
Blast Crisis Hematologic Diseases Homoharringtonine Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Angiogenesis Inhibitors Harringtonines |
Leukemia Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Disease Chronic Myelogenous Leukemia Bone Marrow Diseases Antineoplastic Agents, Phytogenic |
Blast Crisis Disease Attributes Antineoplastic Agents Homoharringtonine Physiological Effects of Drugs Leukemia, Myeloid, Chronic-Phase Leukemia Neoplastic Processes Pathologic Processes Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Neoplasms by Histologic Type Hematologic Diseases |
Growth Substances Myeloproliferative Disorders Leukemia, Myeloid Harringtonines Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Disease Bone Marrow Diseases Antineoplastic Agents, Phytogenic Cell Transformation, Neoplastic |