Myeloproliferative Neoplasms Clinical Trial

Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML

Summary

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

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Full Description

This will be an open label, multicenter study of subcutaneous HHT (omacetaxine mepesuccinate) 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.

View Eligibility Criteria

Eligibility 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
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Sexually active patients and their partners must use an effective double barrier method of contraception

Exclusion Criteria:

New York Heart Association classification (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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT00462943

Recruitment Status:

Completed

Sponsor:

Teva Branded Pharmaceutical Products R&D, Inc.

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There are 29 Locations for this study

See Locations Near You

Teva Investigational Site 303
Los Angeles California, 90033, United States
Teva Investigational Site 308
Beech Grove Indiana, 46107, United States
Teva Investigational Site 311
Baltimore Maryland, 21201, United States
Teva Investigational Site 302
Bronx New York, 10466, United States
Teva Investigational Site 305
Buffalo New York, 14263, United States
Teva Investigational Site 310
Philadelphia Pennsylvania, 19111, United States
Teva Investigational Site 301
Houston Texas, 77030, United States
Teva Investigational Site 314
Seattle Washington, 98109, United States
Teva Investigational Site 313
Montreal , H3a 1, Canada
Teva Investigational Site 309
Toronto , M5G 2, Canada
Teva Investigational Site 329
Bordeaux , 33076, France
Teva Investigational Site 321
Le Chesnay Cedex , 78157, France
Teva Investigational Site 322
Lille , 59000, France
Teva Investigational Site 320
Lyon Cedex 03 , 69437, France
Teva Investigational Site 324
Nice , 06202, France
Teva Investigational Site 328
Paris , 75475, France
Teva Investigational Site 323
Poitiers Cedex , 86021, France
Teva Investigational Site 327
Strasbourg , 67100, France
Teva Investigational Site 325
Toulouse , 31059, France
Teva Investigational Site 331
Berlin , 10117, Germany
Teva Investigational Site 330
Mannheim , 68169, Germany
Teva Investigational Site 350
Budapest , 1096, Hungary
Teva Investigational Site 371
Hyderabad , 50008, India
Teva Investigational Site 370
Mumbai , 400 0, India
Teva Investigational Site 390
Bologna , 41038, Italy
Teva Investigational Site 360
Gdansk , 80-95, Poland
Teva Investigational Site 361
Warszawa , 02776, Poland
Teva Investigational Site 380
Singapore , 16960, Singapore
Teva Investigational Site 340
London , W12 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT00462943

Recruitment Status:

Completed

Sponsor:


Teva Branded Pharmaceutical Products R&D, Inc.

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