Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation

PHASE2CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

September 20, 2006

Primary Completion Date

March 23, 2010

Study Completion Date

June 28, 2013

Conditions
Chronic Myeloid Leukemia
Interventions
DRUG

Omacetaxine mepesuccinate

"Induction:~1.25 mg/m\^2 subcutaneously, twice daily for 14 consecutive days every 28 days until response. Patients not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study.~Maintenance:~1.25 mg/m\^2 subcutaneously, twice daily for 7 consecutive days in a 28-day cycle, for up to 3 years."

Trial Locations (32)

1096

Teva Investigational Site 050, Budapest

10117

Teva Investigational Site 031, Berlin

10467

Teva Investigational Site 002, The Bronx

14263

Teva Investigational Site 005, Buffalo

19111

Teva Investigational Site 010, Philadelphia

21201

Teva Investigational Site 011, Baltimore

30329

Teva Investigational Site 006, Atlanta

31059

Teva Investigational Site 025, Toulouse

32224

Teva Investigational Site 007, Jacksonville

33076

Teva Investigational Site 029, Bordeaux

41038

Teva Investigational Site 090, Bologna

46107

Teva Investigational Site 008, Beech Grove

54511

Teva Investigational Site 026, Vandœuvre-lès-Nancy

59000

Teva Investigational Site 022, Lille

67100

Teva Investigational Site 027, Strasbourg

68169

Teva Investigational Site 030, Mannheim

69437

Teva Investigational Site 020, Lyon

75475

Teva Investigational Site 028, Paris

77030

Teva Investigational Site 001, Houston

78157

Teva Investigational Site 021, Le Chesnay

86021

Teva Investigational Site 023, Poitiers

90033

Teva Investigational Site 003, Los Angeles

169608

Teva Investigational Site 080, Singapore

500082

Teva Investigational Site 071, Hyderabad

02111

Teva Investigational Site 004, Boston

H3a 1a1

Teva Investigational Site 013, Montreal

M5G 2M9

Teva Investigational Site 009, Toronto

06202

Teva Investigational Site 024, Nice

400 014

Teva Investigational Site 070, Mumbai

80-952

Teva Investigational Site 060, Gdansk

02776

Teva Investigational Site 061, Warsaw

W12 0HS

Teva Investigational Site 040, London

Sponsors
All Listed Sponsors
collaborator

Cephalon

INDUSTRY

collaborator

ChemGenex Pharmaceuticals

INDUSTRY

lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY