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DASCERN (CA180-399) = Phase IIb Study of Dasatinib versus Imatinib (Early Switch)

 

Study title

Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP) Who Have Not Achieved an Early Optimal Response to Imatinib (Early switch) [Asia, Europe, North America, South America]

Scientific title

An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib
(EudraCT/Clinicaltrials.gov No. NCT01593254)

Indication and most important inclusion criteria

This study includes Philadelphia chromosome positive (Ph+) patients with Chronic Phase Chronic Myeloid Leukemia (CML-CP) who have achieved Complete Hematologic Response (CHR) but with BCR-ABL >10% International Standard (IS) after 3 months of Imatinib 400 mg treatment. Patients must have started treatment with Imatinib within 6 months of CP-CML diagnosis and currently tolerate Imatinib 400 mg once daily. They must not have received any CML treatment other than Imatinib. To be considered for inclusion in this study, patients must be at least 18 years old, should have an Eastern Co-Operative Group (ECOG) performance status of 0 - 2 as well as adequate kidney and liver function.

Short description of intervention

The purpose of this study is to find out whether CP-CML patients with BCR-ABL > 10% IS after 3 months of treatment with first line Imatinib 400 mg will achieve a greater rate of major molecular response (MMR) by early switching to Dasatinib therapy 100 mg once daily compared with continued treatment with Imatinib at any dose.

Patients in Group 1 will receive:
Imatinib ≥ 400 mg tablets by mouth once daily or twice daily depending on the dose selected, up to 84 months

Patients in Group 2 will receive:
Dasatinib 100 mg tablet by mouth once daily up to 84 months

Type of study

Trials after treatment failure

Current status

Recruiting

Study sponsor

Bristol-Myers Squibb

Scientific lead / contact

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Contact: First line of the email MUST contain NCT01593254 and Site #.

Principal investigator

See site locations

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Argentina

Local Institution
Buenos Aires, C1431FWO
Contact: Site 0051

Local Institution
Buenos Aires, 1221
Contact: Site 0080

Local Institution
Ciudad de Buenos Aires, C1114AAP
Contact: Site 0080

Local Institution
Corrientas, Argentina, Provincia de Corientas, 3400
Contact: Site 0100

Local Institution
La Plata, Buenos Aires, B1900
Contact: Site 0093

Local Institution
San Miguel de Tucuman, Tucuman, 4000
Contact: Site 0049

Local Institution La Plata,
Buenos Aires, B1900
Contact: Site 0093

Local Institution
San Miguel de Tucuman, Tucuman, 4000
Contact: Site 0049

Local Institution
La Plata, Buenos Aires, B1900
Contact: Site 0093

Local Institution
San Miguel de Tucuman, Tucuman, 4000
Contact: Site 0049


Austria

Local Institution
Fürstenfeld, 8280
Contact: Site 0066

Local Institution
Graz, 8036
Contact: Site 0043

Local Institution
Innsbruck, 6020
Contact: Site 0026

Local Institution
Linz, 4010
Contact: Site 0024

Local Institution
Wels, 4600
Contact: Site 0022

Local Institution
Wien, 1090

Belgium

Local Institution
Antwerpen, 2060
Contact: Site 0099

Local Institution
Brugge, 8000
Contact: Site 0065

Local Institution
Yvoir, 5530
Contact: Site 0029


Brazil

Local Institution
Goiania, Goias, 74605-020
Contact: Site 0083

Local Institution
Campinas - SP, Sao Paulo, CEP13083-878
Contact: Site 0063

Local Institution
Curittiba-PR, CEP 80060-900
Contact: Site 0063

Local Institution
Ribeirao Preto, Sao Paulo, 14048
Contact: Site 0061

Local Institution
Rio de Janeiro, 20211
Contact: Site 0062

Local Institution
Rio de Janeiro, 230-130
Contact: Site 0058

Local Institution
Sao Paulo, 08270
Contact: Site 0059


Canada

Local Institution
Saint John, New Brunswick, E2L 4L2
Contact: Site 0020


China

Local Institution
Beijing, Beijing, 100034
Contact: Site 0071

Local Institution
Fuzhou, Fujian, 350001
Contact: Site 0070

Local Institution
Guangzhou, Guangdong, 510515
Contact: Site 0074

Local Institution
Guangzhou, Guangdong, 510080
Contact: Site 0082

Local Institution
Ha'erbin, Heilongjiang, 150010
Contact: Site 0084

Local Institution
Wuhan, Hubei, 430022
Contact: Site 0096

Local Institution
Wuhan, Hubei, 430030
Contact: Site 0102

Local Institution
Nanjing, Jiangsu, 210029
Contact: Site 0073

Local Institution
Soochow, Jiangsu, 215006
Contact: Site 0077

Local Institution
Shenyang, Liaoning, 110001
Contact: Site 0094

Local Institution
Shanghai, Shanghai, 200025
Contact: Site 0076

Local Institution
Chengdu City, Sichuan, 610041
Contact: Site 0075

Local Institution
Tianjin, Tianjin, 300020
Contact: Site 0069

Local Institution
Hangzhou, Zhejiang, 310003
Contact: Site 0072

Local Institution
Beijing, 100071
Contact: Site 0086

Local Institution
Xi'an, 710032
Contact: Site 0088

Local Institution
Jinan, 250012
Contact: Site 0101


Czech Republic

Local Institution
Brno, 625 00
Contact: Site 0032

Local Institution
Olomouc, 775 20
Contact: Site 0056

Local Institution
Prague 2, 128 20
Contact: Site 0067

Local Institution
Praha 10, 100 34
Contact: Site 0031


France

Local Institution
Le Chesnay Cedex, 78157
Contact: Site 0045

Local Institution
Lille CEDEX, 59037
Contact: Site 0041

Local Institution
Nantes Cedex 1, 44000
Contact: Site 0035

Local Institution
Pierre Benite cedex, 69495
Contact: Site 0037

Local Institution
Pringy Cedex, 74374
Contact: Site 0081

Local Institution
Vandoeuvre les Nancy, 54511
Contact: Site 0038


Italy

Local Institution
Bari, 70124
Contact: Site 0092

Local Institution
Bologna, 40138
Contact: Site 0044

Local Institution
Catania, 95124
Contact: Site 0034

Local Institution
Firenze, 50134
Contact: Site 0027

Local Institution
Monza, 20900
Contact: Site 0046

Local Institution
Napoli, 80131
Contact: Site 0053

Local Institution
Orbassano, Torino, 10043
Contact: Site 0025

Local Institution
Roma, 00144
Contact: Site 0021

Local Institution
Roma, 00161
Contact: Site 0033


Korea, Republic of

Local Institution
Seoul, 135-710
Contact: Site 0039

Local Institution
Seoul, 137-701
Contact: Site 0050

Local Institution
Seoul, 138-736
Contact: Site 0040


Poland

Local Institution
Gdansk, Poland, 80-952
Contact: Site 0047

Local Institution
Katowice, 40-032
Contact: Site 0098

Local Institution
Krakow, 30-510
Contact: Site 0048

Local Institution
Warszawa, 02-776
Contact: Site 0064


Spain

Local Institution
Las Palmas de Gran Canaria, 35010
Contact: Site 0015

Local Institution
L'Hospitalet del Llobregat, 08908
Contact: Site 0018

Local Institution
Madrid, 28007
Contact: Site 0012

Local Institution
Salamanca, Castilla Leon, 37007
Contact: Site 0013

Local Institution
Santiago de Compostela, 15706
Contact: Site 0017

Local Institution
Toledo, 45004
Contact: Site 0011


Thailand

Local Institution
Bangkok, 10400
Contact: Site 0054

Local Institution
Chiang Mai, 50200
Contact: Site 0055

Local Institution
Khon-Kaen, 40002
Contact: Site 0052


United States

California
Pacific Cancer Medical Center Inc
Anaheim, California, 92801
Contact: Ajit Maniam, Site 0004

Southern California Permanente Medical Group
BellFlower, California, 90706
Contact: Han Koh, Site 0006

Kaiser Permanente Medical Center
Vallejo, California, 94589
Contact: Louis Fehrenbacher, Site 0009

Innovative Clinical Research Institute
Whittier, California, 90603
Contact: Richy Agajanian, Site 0078

Connecticut
Cancer Center Of Central Connecticut
Southington, Connecticut, 06489
Contact: Peter Byeff, Site 0089

Indiana
Northern Indiana Cancer Research Consortium
Crown Point, Indiana, 46307

Franciscan Physiscian Network Oncology And Hematology Services
Indianapolis, Indiana, 46237
Contact: S. Rubenstein, Site 0003

Iowa
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
Contact: Usha Perepu, Site 0090

Minnesota
Mayo Clinic
Rochester, Minnesota, 55905
Contact: Aref Al-Kali, Site 0010

Ohio
Oncology Hematology Care, Incorporated
Cincinnati, Ohio, 45242
Contact: James Essell, Site 0002

Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Contact: Ian Winchester Flinn, Site 0001

Texas
Michael E Debakey Va Medical Center
Houston, Texas, 77030
Contact: Sarvari Yellapragada, Site 0079

West Virginia
Edwards Comprehensive Cancer Center-University Oncology Services
Huntington, West Virginia, 25701
Contact: Mohamad Khasawneh, Site 0016

Wisconsin
Froedtert Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
Contact: Ehab Atallah, Site 0005 414-805-4600