Welcome
Support Centre
23 October 2014 
Current Controlled Trials - Clinical Trials
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Introduction
English introduction Introduction en franšais Deutsche einleitung
Introducciˇn espa˝ola Introduzione in italiano
 
Find trials
active registers
mental health register
archived registers
all registers
tips on searching
 
 
Information
about mRCT
mRCT FAQs

DISCLAIMER
The site should not be used to diagnose or treat a health problem. Please consult your doctor.
Terms & conditions

DUPLICATION
Your search result may contain a number of different records for the same trial. This occurs when the same trial is listed in more than one register.

[ Print-friendly version ]
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleAdvanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
Current status of trialActive, not recruiting
Sponsors and collaboratorsBristol-Myers Squibb
Information provided byBristol-Myers Squibb
ClinicalTrials.gov identifierNCT00123487
PurposeThis is a phase II study of BMS-354825 in subjects with chronic myelogenous leukemia in
accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome
positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib
mesylate (Gleevec).
Condition(s)Myeloid Leukemia, Chronic, Accelerated Phase
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Intervention(s)Drug: dasatinib
Drug: dasatinib
Drug: dasatinib
Drug: dasatinib
PhasePhase II
Study type and designAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleA Randomized Two-Arm, Multicenter, Open-Label Phase II Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)
Primary outcomeTo estimate the Complete Hematological Response rate of 70 and 140 mg of BMS-354825 in patients who have primary or acquired resistance to imatinib 81 months No
Secondary outcomeProgression free and overall survival 81 months No
Study startJune 2005
Minimum age18 Years
Maximum age90 Years
GenderBoth
Eligibility criteriaInclusion Criteria:

- Subjects with Ph+ (or BCR/ABL+) accelerated phase chronic myeloid leukemia whose
disease has primary or acquired hematologic resistance to imatinib mesylate or who
are intolerant of imatinib mesylate

- Men and women, 18 years of age or older

- Adequate hepatic function

- Adequate renal function

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for a period of at least 1
month before and at least 3 months after the study in such a manner that the risk of
pregnancy is minimized

- ECOG performance status score 0 - 2

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy

- Uncontrolled or significant cardiovascular disease

- Medications that increase bleeding risk

- Medications that change heart rhythms

- Dementia or altered mental status that would prohibit the understanding or rendering
of informed consent

- History of significant bleeding disorder unrelated to CML

- Concurrent incurable malignancy other than CML

- Evidence of organ dysfunction or digestive dysfunction that would prevent
administration of study therapy

- Prior therapy with BMS-35425

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into this study
Study chairs or principal investigatorsBristol-Myers Squibb, Study Director, Bristol-Myers Squibb
LocationsAlabama, United States

University Of Alabama-Birmingham
Birmingham
Alabama
35294

California, United States

Loma Linda University Cancer Center
Loma Linda
California
92354

California, United States

Ucla Dept. Of Medicine
Los Angeles
California
90095

District of Columbia, United States

Washington Cancer Institute At Washington Hospital Center
Washington
District of Columbia
20010

Florida, United States

University Of Miami
Miami
Florida
33136

Georgia, United States

Emory University School Of Medicine
Atlanta
Georgia
30322

Illinois, United States

Northwestern University
Chicago
Illinois
60611

Illinois, United States

The University Of Chicago
Chicago
Illinois
60637

Indiana, United States

Indiana University Cancer Center
Indianapolis
Indiana
46202

Kentucky, United States

University Of Kentucky
Lexington
Kentucky
40536

Maryland, United States

University Of Maryland
Baltimore
Maryland
21201

Massachusetts, United States

Dana-Farber Cancer Institute
Boston
Massachusetts
02115

Michigan, United States

Wayne State University
Detroit
Michigan
48201

Missouri, United States

Washington University School Of Medicine
St. Louis
Missouri
63110

Nebraska, United States

Devetten, Marcel
Omaha
Nebraska
68198

Nebraska, United States

Nebraska Methodist Hospital
Omaha
Nebraska
68114

New Jersey, United States

The Cancer Center At Hackensack University Medical Center
Hackensack
New Jersey
07601

New Jersey, United States

The Cancer Institute Of New Jersey
New Brunswick
New Jersey
08901

New York, United States

New York Presbyterian Hospital
New York
New York
10021

North Carolina, United States

The University Of North Carolina At Chapel Hill
Chapel Hill
North Carolina
27599

Ohio, United States

Cleveland Clinic Foundation
Cleveland
Ohio
44195

Oregon, United States

Oregon Health & Science University
Portland
Oregon
97239

Pennsylvania, United States

Western Pennsylvania Cancer Institute
Pittsburgh
Pennsylvania
15224

Tennessee, United States

The Sarah Cannon Research Institute
Nashville
Tennessee
37203

Texas, United States

The University Of Texas - M.D. Anderson Cancer Center
Houston
Texas
77030

Washington, United States

Seattle Cancer Care Alliance
Seattle
Washington
98109

Buenos Aires, Argentina

Local Institution
Capital Federal
Buenos Aires
1280

New South Wales, Australia

Local Institution
St Leonards
New South Wales
2065

Queensland, Australia

Local Institution
South Brisbane
Queensland
4101

South Australia, Australia

Local Institution
Adelaide
South Australia
5000

Victoria, Australia

Local Institution
Parkville
Victoria
3050

Western Australia, Australia

Local Institution
Perth
Western Australia
WA 6000

Austria

Local Institution
Wien
1090

Belgium

Local Institution
B-Leuven
3000

Belgium

Local Institution
Brugge
8000

Belgium

Local Institution
Bruxelles
1000

Belgium

Local Institution
Charleroi
6000

Belgium

Local Institution
Yvoir
5530

Parana, Brazil

Local Institution
Curitiba
Parana
80060

Rj, Brazil

Local Institution
Rio De Janeiro
Rj
20230

Sao Paulo, Brazil

Local Institution
Campinas
Sao Paulo
13083

Sao Paulo, Brazil

Local Institution
Morumbi
Sao Paulo
05652

Brazil

Local Institution
Sao Paulo
05403

Alberta, Canada

Local Institution
Edmonton
Alberta
T6G 1Z2

British Columbia, Canada

Local Institution
Vancouver
British Columbia
V5Z 1M9

Quebec, Canada

Local Institution
Montreal
Quebec
H3A 1A1

Czech Republic

Local Institution
Brno
625 00

Czech Republic

Local Institution
Prague 2
128 20

Denmark

Local Institution
Aarhus C
8000

Denmark

Local Institution
Herlev
2730

Denmark

Local Institution
Odense C
5000

Finland

Local Institution
Helsinki
00029

France

Local Institution
Caen Cedex
14033

France

Local Institution
Creteil Cedex
94010

France

Local Institution
Grenoble Cedex 9
38043

France

Local Institution
Lille Cedex
59037

France

Local Institution
Marseille Cedex 9
13273

France

Local Institution
Nantes
44000

France

Local Institution
Paris Cedex 10
75475

France

Local Institution
Pessac
33604

France

Local Institution
Pierre Benite
69495

France

Local Institution
Poitiers Cedex
86021

France

Local Institution
Strasbourg Cedex
67091

Germany

Local Institution
Dresden
01307

Germany

Local Institution
Frankfurt
60590

Germany

Local Institution
Hamburg
20246

Germany

Local Institution
Leipzig
04103

Germany

Local Institution
Mainz
55131

Germany

Local Institution
Mannheim
68163

Greece

Local Institution
Athens
10676

Hungary

Local Institution
Budapest
1135

Galway, Ireland

Local Institution
Co Galway
Galway

Ireland

Local Institution
Dublin

Israel

Local Institution
Ramat-Gan
52621

Italy

Local Institution
Bari
70124

Italy

Local Institution
Bologna
40138

Italy

Local Institution
Monza
20052

Italy

Local Institution
Napoli
80131

Italy

Local Institution
Orbassano (To)
10043

Italy

Local Institution
Roma
00144

Korea, Republic of

Local Institution
Jeollanam-Do

Korea, Republic of

Local Institution
Seoul
138-736

Korea, Republic of

Local Institution
Seoul
110-744

Korea, Republic of

Local Institution
Seoul
137-040

Netherlands

Local Institution
Rotterdam
3075 EA

Norway

Local Institution
Trondheim
7006

Lima, Peru

Local Institution
Jesus Maria
Lima
11

Peru

Local Institution
Lima
34

Philippines

Local Institution
Quezon City
1102

Poland

Local Institution
Gdansk
80 211

Poland

Local Institution
Katowice
40032

Poland

Local Institution
Krakow
31501

Poland

Local Institution
Lodz
93510

Poland

Local Institution
Lublin
20 950

Poland

Local Institution
Warsaw
02097

Russian Federation

Local Institution
Moscow
125167

Russian Federation

Local Institution
St.Petersburg
197022

Singapore

Local Institution
Singapore
169608

Free State, South Africa

Local Institution
Bloemfontein
Free State
9301

Gauteng, South Africa

Local Institution
Groenkloof
Gauteng
0181

Gauteng, South Africa

Local Institution
Parktown
Gauteng
2193

Western Cape, South Africa

Local Institution
Observatory
Western Cape
7925

Spain

Local Institution
Barcelona
08036

Spain

Local Institution
Madrid
28034

Spain

Local Institution
Madrid
28006

Spain

Local Institution
Valencia
46009

Sweden

Local Institution
Lund
22185

Sweden

Local Institution
Stockholm
171 76

Sweden

Local Institution
Umea
901 85

Sweden

Local Institution
Uppsala
751 85

Switzerland

Local Institution
Basel
4031

Taiwan

Local Institution
Taipei
100

Taiwan

Local Institution
Taipei
112

Taiwan

Local Institution
Taoyuan
333

Thailand

Local Institution
Bangkok
10400

Greater London, United Kingdom

Local Institution
London
Greater London
W12 ONN

Merseyside, United Kingdom

Local Institution
Liverpool
Merseyside
L7 8XP

Scotland, United Kingdom

Local Institution
Glasgow
Scotland
G12 OXB

Tyne And Wear, United Kingdom

Local Institution
Newcastle
Tyne And Wear
NE2 4HH
LinksBMS Clinical Trials Disclosure
Investigator Inquiry form
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
ResultsChu SC, Tang JL, Li CC. Dasatinib in chronic myelogenous leukemia. N Engl J Med. 2006 Sep 7;355(10):1062-3; author reply 1063-4. No abstract available.
Study ID numbersCA180-035
Last updatedFebruary 21, 2012
Record first receivedJuly 21, 2005
ClinicalTrials.gov identifierNCT00123487
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 Current Controlled Trials Ltd. Part of Springer Science+Business Media. | terms & conditions | privacy statement | cookies