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A Phase III Study of Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase CML
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleA Phase III Study of Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase CML
Current status of trialActive, not recruiting
Sponsors and collaboratorsBristol-Myers Squibb
Information provided byBristol-Myers Squibb
ClinicalTrials.gov identifierNCT00481247
PurposeThe purpose of this clinical research study is to compare the rate of confirmed complete
cytogenetic response (cCCyR) of dasatinib to imatinib therapy within 12 months after
randomization in newly diagnosed chronic phase Philadelphia positive chronic myeloid
leukemia (Ph+ CML) patients. The safety of this treatment will also be studied.
Condition(s)Myeloid Leukemia, Chronic
Intervention(s)Drug: Dasatinib
Drug: Imatinib
PhasePhase III
Study type and designAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleAn Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Primary outcomeNumber of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months Pre-treatment, every 3 months up to 12 months No Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from Bone Marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A confirmed cytogenetic response (cCCyR)=those in which all measurements up to at least 28 days after the initial response show an equivalent or better cytogenetic response.
Secondary outcomeTime-in cCCyR at Any Time Every 3 months for 2 years, then once per year for 3 years and/ or once per year for subjects in confirmed complete cytogenetic response at any timepoint or investigator's decision No Time-in cCCyR at any time was computed for all randomized subjects. For subjects with cCCyR at any time, it is measured from the time measurement criteria are first met for CCyR(provided it is confirmed later) until the date of progression or death. Subjects with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Subjects without cCCyR are considered to have progressed on day 1.
Number of Participants With Major Molecular Response (MMR) at Any Time Pre-treatment, every 3 months for 2 years, then every 6 months for 3 years No Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction (RQ-PCR). A major molecular response (MMR) is defined as a ratio BCR-ABL/ABL ⿤0.1% on the international scale (i.e., at least 3 log reduction from a standardized baseline value).
Time to Confirmed CCyR Overall Every 3 months for 2 years, then once per year for 3 years and/ or once per year for subjects in confirmed complete cytogenetic response at any timepoint No The Time-to cCCyR for participants with cCCyR is defined as the time from the randomization date until criteria are first met for CCyR (provided it is confirmed later). The time-to cCCyR for all randomized subjects censors non-responders who do not progress at their cytogenetic assessments and non-responders who progress at the maximum time of all randomized subjects.
Time to MMR Overall Every 3 months for 2 years, then every 6 months for 3 years No The Time-to MMR for participants with MMR is defined as the time from randomization date until measurement criteria are first met for MMR. The time-to MMR for all randomized subjects censor non-responders who do not progress at their last molecular assessments and non-responders who progress at the maximum time of all randomized subjects.
Percentage of Participants With Progression-Free Survival (PFS) at 12 Months Participants were followed for at least 5 years No PFS=time from randomization until progression (any progression/death within 30 days of last dosing date, or between 30-60 days of last dosing prior to start of secondary therapy). Those who did not progress/die or who progressed/died after 60 days of last dose were censored at last on-study hematologic/cytogenetic assessment; those with progression/death 30-60 days of last dosing date & after start date of secondary therapy censored at last on-study hematologic/cytogenetic assessment prior to start of secondary therapy; those who had not received study treatment censored on date randomized.
Percentage of Participants With Overall Survival (OS) at 12 Months Participants were followed for at least 5 years No Overall survival (OS) was defined as the time from randomization to the date of death. If the participant had not died, survival was censored on last date the participant was known to be alive.
Study startSeptember 2007
Minimum age18 Years
Maximum ageN/A
GenderBoth
Eligibility criteriaInclusion Criteria:

- Male & Female â¿¥18 years

- Chronic Phase Ph+ CML

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-2

Exclusion Criteria:

- Pleural Effusion

- Uncontrolled cardiovascular (CV) disease

- Significant bleeding disorder unrelated to CML

- Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments
except anagrelide/hydroxyurea
Study chairs or principal investigatorsBristol-Myers Squibb, Study Director, Bristol-Myers Squibb
LocationsBuenos Aires, Argentina

Local Institution
Capital Federal
Buenos Aires
1280

Buenos Aires, Argentina

Local Institution
Capital Federal
Buenos Aires
C1114AAN

Buenos Aires, Argentina

Local Institution
La Plata
Buenos Aires
1900

Argentina

Local Institution
Buenos Aires
1021

New South Wales, Australia

Local Institution
Waratah
New South Wales
2298

Queensland, Australia

Local Institution
Brisbane
Queensland
4029

Queensland, Australia

Local Institution
Greenslopes
Queensland
4120

Western Australia, Australia

Local Institution
Perth
Western Australia
WA 6000

Austria

Local Institution
Innsbruck
6020

Austria

Local Institution
Wien
1090

Belgium

Local Institution
Brugge
8000

Belgium

Local Institution
Bruxelles
1200

Parana, Brazil

Local Institution
Curitiba
Parana
80060

Sao Paulo, Brazil

Local Institution
Campinas
Sao Paulo
13083

Sao Paulo, Brazil

Local Institution
Jau
Sao Paulo
17210

Brazil

Local Institution
Rio De Janeiro
20230130

Brazil

Local Institution
Sao Paulo
05403

Brazil

Local Institution
Sao Paulo
01401

Metropolitana, Chile

Local Institution
Santiago
Metropolitana
00

Beijing, China

Local Institution
Beijing
Beijing
100044

Fujian, China

Local Institution
Fuzhou
Fujian
350001

Shanghai, China

Local Institution
Shanghai
Shanghai
200025

Tianjin, China

Local Institution
Tianjin
Tianjin
300020

Bogota, Colombia

Local Institution
Colombia
Bogota
00000

Colombia

Local Institution
Bogota

Czech Republic

Local Institution
Brno
625 00

Czech Republic

Local Institution
Hradec Kralove
500 05

Czech Republic

Local Institution
Olomouc
77520

Czech Republic

Local Institution
Prague 2
128 20

Denmark

Local Institution
Aarhus
8000

Cedex 1, France

Local Institution
Nantes
Cedex 1
44093

France

Local Institution
Brest Cedex 02
29609

France

Local Institution
Lille Cedex
59037

France

Local Institution
Limoges
87042

France

Local Institution
Montpellier Cedex
34295

France

Local Institution
Paris
75015

France

Local Institution
Paris Cedex 10
75475

France

Local Institution
Pierre Benite Cedex
69495

France

Local Institution
Poitiers Cedex
86021

France

Local Institution
Rennes
35033

France

Local Institution
Strasbourg Cedex
67091

France

Local Institution
Toulouse Cedex 09
31059

France

Local Institution
Vandoeuvre Les Nancy
54511

Germany

Local Institution
Berlin
13353

Germany

Local Institution
Rostock
18055

Germany

Local Institution
Tuebingen
72076

Germany

Local Institution
Ulm
89081

Greece

Local Institution
Thessaloniki
57010

Hungary

Local Institution
Budapest
1097

Hungary

Local Institution
Debrecen
4012

Tamilnadu, India

Local Institution
Vellore
Tamilnadu
632004

India

Local Institution
Ahmedabad
380009

India

Local Institution
Cochin
682304

India

Local Institution
Mumbai
400014

India

Local Institution
Mumbai
400012

India

Local Institution
Mumbai
400010

India

Local Institution
Trivandrum
695011

Italy

Local Institution
Bologna
40138

Italy

Local Institution
Catania
95124

Italy

Local Institution
Monza (Mb)
20900

Italy

Local Institution
Orbassano (To)
10043

Italy

Local Institution
Pavia
27100

Italy

Local Institution
Roma
00161

Italy

Local Institution
Roma
00144

Aichi, Japan

Local Institution
Nagoya
Aichi
466-8650

Chiba, Japan

Local Institution
Kamogawa-Shi
Chiba
296-8602

Fukuoka, Japan

Local Institution
Fukuoka-Shi
Fukuoka
814-0180

Iwate, Japan

Local Institution
Morioka-Shi
Iwate
020-8505

Kagoshima, Japan

Local Institution
Kagoshima-Shi
Kagoshima
890-0064

Kanagawa, Japan

Local Institution
Yokohama
Kanagawa
232-0024

Miyagi, Japan

Local Institution
Sendai
Miyagi

Okayama, Japan

Local Institution
Okayama-Shi
Okayama
7008558

Osaka, Japan

Local Institution
Osaka-Shi
Osaka
545-8586

Tokyo, Japan

Local Institution
Bunkyo-Ku
Tokyo
113-8677

Tokyo, Japan

Local Institution
Shinagawa-Ku
Tokyo
1418625

Japan

Local Institution
Kyoto

Korea, Republic of

Local Institution
Seoul
138-736

Korea, Republic of

Local Institution
Seoul
137-040

Distrito Federal, Mexico

Local Institution
Mexico
Distrito Federal
02990

Distrito Federal, Mexico

Local Institution
Mexico D.F.
Distrito Federal
14000

Distrito Federal, Mexico

Local Institution
Mexico, D. F.
Distrito Federal
06726

Nuevo Leon, Mexico

Local Institution
Monterrey
Nuevo Leon
64460

Sinaloa, Mexico

Local Institution
Culiacan
Sinaloa
80230

Netherlands

Local Institution
Groningen
9700 RB

Netherlands

Local Institution
Nijmegen
6500 HB

Peru

Local Institution
Arequipa

Peru

Local Institution
Lima
34

Peru

Local Institution
Lima
11

Poland

Local Institution
Katowice
40-038

Poland

Local Institution
Krakow
31501

Poland

Local Institution
Lodz
93-510

Poland

Local Institution
Poznan
60869

Poland

Local Institution
Warsaw
02776

Russian Federation

Local Institution
Moscow
125167

Russian Federation

Local Institution
Rostov-On-Don
344022

Russian Federation

Local Institution
St.Petersburg
197022

Singapore

Local Institution
Singapore
169608

Spain

Local Institution
A Coruna
15706

Spain

Local Institution
Barcelona
08907

Spain

Local Institution
Barcelona
08036

Spain

Local Institution
Barcelona
08003

Spain

Local Institution
Madrid
28006

Spain

Local Institution
Madrid
28046

Spain

Local Institution
Malaga
29010

Spain

Local Institution
Oviedo
33006

Spain

Local Institution
Salamanca
37007

Spain

Local Institution
Valencia
46009

Turkey

Local Institution
Ankara
06100

Turkey

Local Institution
Kayseri
38039
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
Study ID numbersCA180-056; 2006-005712-27
Last updatedFebruary 15, 2012
Record first receivedMay 30, 2007
ClinicalTrials.gov identifierNCT00481247
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
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