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Myeloid Leukemia, ChronicPhase 3DASISIONNCT00481247

A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

A Phase 3 study testing Dasatinib and Imatinib in people with Myeloid Leukemia, Chronic, run by Bristol-Myers Squibb at 109 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloid Leukemia, Chronic
What is being tested?
Dasatinib and Imatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
547 participants
Where
109 sitesin 27 countries
Study dates
Sep 2007to Dec 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged 18 years and older
  • Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)
  • Eastern Cooperative Oncology Group Performance Status score of 0-2

Who cannot join

  • Pleural Effusion
  • Uncontrolled cardiovascular disease
  • Significant bleeding disorder unrelated to CML
  • Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea

Trial locations and contacts

109 sites in 27 countries.

109 sites in 27 countries

France13 sites

  • Local Institution

    Brest, 29609

  • Local Institution

    Lille, 59037

  • Local Institution

    Limoges, 87042

  • Local Institution

    Montpellier, 34295

  • Local Institution

    Nantes, Cedex 1, 44093

  • Local Institution

    Paris, 75015

  • Local Institution

    Paris, 75475

  • Local Institution

    Pierre-Bénite, 69495

  • Local Institution

    Poitiers, 86021

  • Local Institution

    Rennes, 35033

  • Local Institution

    Strasbourg, 67091

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Japan12 sites

  • Local Institution

    Bunkyo-ku, Tokyo, 113-8677

  • Local Institution

    Fukuoka, Fukuoka, 814-0180

  • Local Institution

    Kagoshima, Kagoshima-ken, 890-0064

  • Local Institution

    Kamogawa-shi, Chiba, 2968602

  • Local Institution

    Kyoto, Kyoto, 6028566

  • Local Institution

    Morioka, Iwate, 020-8505

  • Local Institution

    Nagoya, Aichi-ken, 466-8650

  • Local Institution

    Okayama, Okayama-ken, 7008558

  • Local Institution

    Osaka, Osaka, 545-8586

  • Local Institution

    Sendai, Miyagi

  • Local Institution

    Shinagawa-ku, Tokyo, 1418625

  • Local Institution

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Spain10 sites

  • Local Institution

    A Coruña, 15706

  • Local Institution

    Barcelona, 08003

  • Local Institution

    Barcelona, 08036

  • Local Institution

    Barcelona, 08907

  • Local Institution

    Madrid, 28006

  • Local Institution

    Madrid, 28046

  • Local Institution

    Málaga, 29010

  • Local Institution

    Oviedo, 33006

  • Local Institution

    Salamanca, 37007

  • Local Institution

    Valencia, 46009

Other trials in Spain

India7 sites

  • Local Institution

    Ahmedabad, 380009

  • Local Institution

    Kochi, 682304

  • Local Institution

    Mumbai, 400010

  • Local Institution

    Mumbai, 400012

  • Local Institution

    Mumbai, 400014

  • Local Institution

    Trivandrum, 695011

  • Local Institution

    Vellore, Tamil Nadu, 632004

Other trials in India

Italy7 sites

  • Local Institution

    Bologna, 40138

  • Local Institution

    Catania, 95124

  • Local Institution

    Monza (mb), 20900

  • Local Institution

    Orbassano (to), 10043

  • Local Institution

    Pavia, 27100

  • Local Institution

    Roma, 00144

  • Local Institution

    Roma, 00161

Other trials in Italy

Brazil6 sites

  • Local Institution

    Campinas, São Paulo, 13083

  • Local Institution

    Curitiba, Paraná, 80060

  • Local Institution

    Jaú, São Paulo, 17210

  • Local Institution

    Rio de Janeiro, Rio de Janeiro, 20230130

  • Local Institution

    São Paulo, São Paulo, 01401

  • Local Institution

    São Paulo, São Paulo, 05403

Other trials in Brazil

Mexico5 sites

  • Local Institution

    Culiacán, Sinaloa, 80230

  • Local Institution

    Mexico City, Mexico City, 02990

  • Local Institution

    Mexico City, Mexico City, 14000

  • Local Institution

    Mexico, D. F., Mexico City, 06726

  • Local Institution

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Poland5 sites

  • Local Institution

    Chorzów, 41-500

  • Local Institution

    Krakow, 31501

  • Local Institution

    Lodz, 93-510

  • Local Institution

    Poznan, 60869

  • Local Institution

    Warsaw, 02776

Other trials in Poland

Australia4 sites

  • Local Institution

    Brisbane, Queensland, 4029

  • Local Institution

    Greenslopes, Queensland, 4120

  • Local Institution

    Perth, Western Australia, WA 6000

  • Local Institution

    Waratah, New South Wales, 2298

Other trials in Australia

China4 sites

  • Local Institution

    Beijing, Beijing Municipality, 100044

  • Local Institution

    Fuzhou, Fujian, 350001

  • Local Institution

    Shanghai, Shanghai Municipality, 200025

  • Local Institution

    Tianjin, Tianjin Municipality, 300020

Other trials in China

Czechia4 sites

  • Local Institution

    Brno, 625 00

  • Local Institution

    Hradec Králové, 500 05

  • Local Institution

    Olomouc, 775 20

  • Local Institution

    Prague, 128 20

Other trials in Czechia

Germany4 sites

  • Local Institution

    Berlin, 13353

  • Local Institution

    Rostock, 18055

  • Local Institution

    Tübingen, 72076

  • Local Institution

    Ulm, 89081

Other trials in Germany

Argentina3 sites

  • Local Institution

    Buenos Aires, Buenos Aires, 1021

  • Local Institution

    Capital Federal, Buenos Aires, 1280

  • Local Institution

    Capital Federal, Buenos Aires, C1114AAN

Other trials in Argentina

Peru3 sites

  • Local Institution

    Arequipa, Arequipa

  • Local Institution

    Lima, Lima Province, 11

  • Local Institution

    Lima, Lima Province, 34

Other trials in Peru

Russia3 sites

  • Local Institution

    Moscow, 125167

  • Local Institution

    Rostov-on-Don, 344022

  • Local Institution

    Saint Petersburg, 197022

Other trials in Russia

Austria2 sites

  • Local Institution

    Innsbruck, 6020

  • Local Institution

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • Local Institution

    Bruges, 8000

  • Local Institution

    Brussels, 1200

Other trials in Belgium

Colombia2 sites

  • Local Institution

    Bogotá

  • Local Institution

    Colombia, Bogota D.C.

Other trials in Colombia

Hungary2 sites

  • Local Institution

    Budapest, 1097

  • Local Institution

    Debrecen, 4012

Other trials in Hungary

Netherlands2 sites

  • Local Institution

    Groningen, 9700 RB

  • Local Institution

    Nijmegen, 6500 HB

Other trials in Netherlands

South Korea2 sites

  • Local Institution

    Seoul, 137-040

  • Local Institution

    Seoul, 138-736

Other trials in South Korea

Turkey (Türkiye)2 sites

  • Local Institution

    Ankara, 06100

  • Local Institution

    Kayseri, 38039

Other trials in Turkey (Türkiye)

United States1 site

  • Molecular Md

    Portland, Oregon, 97219

Other trials in United States

Chile1 site

  • Local Institution

    Santiago, Santiago Metropolitan

Other trials in Chile

Denmark1 site

  • Local Institution

    Aarhus, 8000

Other trials in Denmark

Greece1 site

  • Local Institution

    Thessaloniki, 57010

Other trials in Greece

Singapore1 site

  • Local Institution

    Singapore, 169865

Other trials in Singapore

About this study

Official title: An 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

The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.

Being tested
Dasatinib, Imatinib
Keywords
Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasatinibDrug

    Also called Sprycel®, BMS-354825

    Tablets, oral, dasatinib 50-140 mg once daily (QD)

  • ImatinibDrug

    Tablets, oral, imatinib 200-800 mg, QD

Study groups in NCT00481247
Study groupRoleWhat they receive
DasatinibExperimentalNot described
Receives: Drug: Dasatinib
ImatinibActive comparatorNot described
Receives: Drug: Imatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months

    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 cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.

    Measured: Pretreatment, every 3 months up to 12 months

Secondary outcomes (6)

  1. Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)

    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 cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.

    Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1.

    Measured: Years 2, 3, 4 and 5

  2. Percentage of Participants With Major Molecular Response (MMR) at Any Time

    Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).

    Measured: Planned total follow-up duration of 5 years

  3. Time to Confirmed Complete Cytogenic Response (cCCyR) Overall

    The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants.

    .

    Measured: Day 1 to 5 years

  4. Time to Major Molecular Response (MMR) Overall

    The time to MMR for all randomized participants is defined as the time from randomization date until measurement criteria are first met for MMR. The time to MMR analysis censors nonresponders who do not progress at their last molecular assessments and nonresponders who progress at the maximum time of all randomized participants.

    Measured: Day 1 to 5 years

  5. Percentage of Participants With Progression-free Survival (PFS)

    PFS was defined as the 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 and 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.

    Measured: Participants were followed-up for at least 5 years

  6. Percentage of Participants With Overall Survival (OS)

    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.

    Measured: Participants were followed-up for at least 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionDec 2009
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
547 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00481247
Sponsor's protocol ID
CA180-056
Other IDs
2006-005712-27
Acronym
DASISION
Status last verified
Dec 2016
First submitted
30 May 2007
Last updated
15 Feb 2017
Data monitoring committee
Yes

Publications

  • Glauche I, Kuhn M, Baldow C, Schulze P, Rothe T, Liebscher H, Roy A, Wang X, Roeder I. Quantitative prediction of long-term molecular response in TKI-treated CML - Lessons from an imatinib versus dasatinib comparison. Sci Rep. 2018 Aug 17;8(1):12330. doi: 10.1038/s41598-018-29923-4.

    PubMed 30120281

  • Hughes TP, Saglio G, Quintas-Cardama A, Mauro MJ, Kim DW, Lipton JH, Bradley-Garelik MB, Ukropec J, Hochhaus A. BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase. Leukemia. 2015 Sep;29(9):1832-8. doi: 10.1038/leu.2015.168. Epub 2015 Jun 29.

    PubMed 26118315

  • Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.

    PubMed 24357015

  • Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boque C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014 Jan 23;123(4):494-500. doi: 10.1182/blood-2013-06-511592. Epub 2013 Dec 5.

    PubMed 24311723

  • Kantarjian HM, Shah NP, Cortes JE, Baccarani M, Agarwal MB, Undurraga MS, Wang J, Ipina JJ, Kim DW, Ogura M, Pavlovsky C, Junghanss C, Milone JH, Nicolini FE, Robak T, Van Droogenbroeck J, Vellenga E, Bradley-Garelik MB, Zhu C, Hochhaus A. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012 Feb 2;119(5):1123-9. doi: 10.1182/blood-2011-08-376087. Epub 2011 Dec 9.

    PubMed 22160483

  • Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boque C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D, Baccarani M. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2260-70. doi: 10.1056/NEJMoa1002315. Epub 2010 Jun 5.

    PubMed 20525995

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dasatinib and Imatinib in people with Myeloid Leukemia, Chronic, run by Bristol-Myers Squibb at 109 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in France, Japan, Spain, India, Italy and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months (time frame: Pretreatment, every 3 months up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00481247, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.

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