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Brief Title: Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
Official Title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine. (Omacetaxine) (CGX-635) in the Treatment of Patients With Chronic Myeloid Leukemia. (CML) With the T315I BCR-ABL Gene Mutation
Study ID: NCT00375219
Brief Summary: To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (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.
Detailed Description: 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. Omacetaxine mepesuccinate (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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Teva Investigational Site 003, Los Angeles, California, United States
Teva Investigational Site 007, Jacksonville, Florida, United States
Teva Investigational Site 006, Atlanta, Georgia, United States
Teva Investigational Site 008, Beech Grove, Indiana, United States
Teva Investigational Site 011, Baltimore, Maryland, United States
Teva Investigational Site 004, Boston, Massachusetts, United States
Teva Investigational Site 002, Bronx, New York, United States
Teva Investigational Site 005, Buffalo, New York, United States
Teva Investigational Site 010, Philadelphia, Pennsylvania, United States
Teva Investigational Site 001, Houston, Texas, United States
Teva Investigational Site 013, Montreal, , Canada
Teva Investigational Site 009, Toronto, , Canada
Teva Investigational Site 029, Bordeaux, , France
Teva Investigational Site 021, Le Chesnay Cedex, , France
Teva Investigational Site 022, Lille, , France
Teva Investigational Site 020, Lyon Cedex 03, , France
Teva Investigational Site 024, Nice, , France
Teva Investigational Site 028, Paris, , France
Teva Investigational Site 023, Poitiers Cedex, , France
Teva Investigational Site 027, Strasbourg, , France
Teva Investigational Site 025, Toulouse, , France
Teva Investigational Site 026, Vandoeuvre-Les-Nancy CEDEX, , France
Teva Investigational Site 031, Berlin, , Germany
Teva Investigational Site 030, Mannheim, , Germany
Teva Investigational Site 050, Budapest, , Hungary
Teva Investigational Site 071, Hyderabad, , India
Teva Investigational Site 070, Mumbai, , India
Teva Investigational Site 090, Bologna, , Italy
Teva Investigational Site 060, Gdansk, , Poland
Teva Investigational Site 061, Warszawa, , Poland
Teva Investigational Site 080, Singapore, , Singapore
Teva Investigational Site 040, London, , United Kingdom
Name: Jorge Cortes, MD
Affiliation: Univ. of Texas M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Andreas Hochhaus, MD Prof Dr
Affiliation: Mannheim der Universitat Heidelberg
Role: PRINCIPAL_INVESTIGATOR