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Chronic Phase Chronic Myeloid LeukemiaPhase 2DASCERNNCT01593254

Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib

A Phase 2 study testing Imatinib and Dasatinib in people with Chronic Phase Chronic Myeloid Leukemia, run by Bristol-Myers Squibb at 101 sites in 15 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 study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Phase Chronic Myeloid Leukemia
What is being tested?
Imatinib and Dasatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
101 sitesin 15 countries
Study dates
12 Sep 2012to 12 Apr 2022
Phase
Phase 2
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

  • Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (CHR) but without one log BCR-ABL reduction (BCR-ABL level >10% IS) 3 months of imatinib 400mg treatment. (Imatinib transient dose adjustments due to Adverse Event (AEs) are allowed with a maximum of 2 weeks interruption of treatment with imatinib (cumulative) within the 3 month period before randomization). Imatinib monotherapy must have been started within 6 months of CP-CML diagnosis (Ph + /BCR-ABL detection)
  • Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment interruption or dose reductions are required to be on treatment with 400 mg imatinib for two weeks immediately prior to randomization to ensure tolerance to imatinib
  • Eastern Co-Operative Group (ECOG) performance status = 0 - 2
  • Adequate renal function defined as serum creatinine ≤3 times the institutional upper limit of normal (ULN)
  • Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the institutional ULN

Who cannot join

  • Previous diagnosis of accelerated phase or blast crisis
  • Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases at baseline bone marrow cytogenetic test, unless the same abnormalities were present at diagnosis. Patients with no evidence of clonal evolution, including those patients whose cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months, are eligible for the study
  • Subjects with less than CHR after 3 months of imatinib treatment or lost CHR after initial achievement
  • Documented T315I/A, F317L, or V299L mutations (if already available - not required for screening)
  • A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy

Trial locations and contacts

101 sites in 15 countries.

101 sites in 15 countries

United States21 sites

  • Local Institution - 0004

    Anaheim, California, 92801

  • Local Institution - 0002

    Cincinnati, Ohio, 45242

  • Northern Indiana Cancer Research Consortium

    Crown Point, Indiana, 46307

  • Northwestern University

    Evanston, Illinois, 60208

  • Local Institution - 0006

    Fontana, California, 92335

  • Michael E Debakey VAMC

    Houston, Texas, 77030

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • University Of Iowa

    Iowa City, Iowa, 52242

  • Institute of Oncology Hematology Biomedical Research

    Laredo, Texas, 78041

  • University Of Southern California University Hospital

    Los Angeles, California, 90033

  • Local Institution - 0005

    Milwaukee, Wisconsin, 53226

  • Local Institution - 0001

    Nashville, Tennessee, 37203-1625

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0010

    Rochester, Minnesota, 55905

  • Local Institution - 0110

    Roseville, California, 95661

  • Local Institution - 0112

    San Jose, California, 95119

  • Local Institution - 0089

    Southington, Connecticut, 06489

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Local Institution - 0009

    Vallejo, California, 94589-2441

  • Local Institution - 0078

    Whittier, California, 90603

Other trials in United States

China18 sites

  • Local Institution - 0071

    Beijing, Beijing Municipality, 100044

  • Local Institution - 0086

    Beijing, Beijing Municipality, 100071

  • Local Institution - 0075

    Chengdu, Sichuan, 610041

  • Local Institution - 0070

    Fuzhou, Fujian, 350001

  • Local Institution - 0082

    Guangzhou, Guangdong, 510080

  • Local Institution - 0074

    Guangzhou, Guangdong, 510515

  • Local Institution - 0084

    Haerbin, Heilongjiang, 150010

  • Local Institution - 0072

    Hangzhou, 310003

  • Local Institution - 0101

    Jinan, Shandong, 250012

  • Local Institution - 0073

    Nanjing, Jiangsu, 210029

  • Local Institution - 0076

    Shanghai, 200025

  • Local Institution - 0094

    Shenyang, Liaoning, 110001

  • Local Institution - 0103

    Shenzhen, Guandong, 518035

  • Local Institution - 0077

    Suzhou, Jiangsu, 215000

  • Local Institution - 0069

    Tianjin, Tianjin Municipality, 300020

  • Local Institution - 0102

    Wuhan, Hubei, 430030

  • Local Institution - 0096

    Wuhan, 430030

  • Local Institution - 0088

    Xi'an, Shan3xi, 710000

Other trials in China

Italy10 sites

  • Local Institution

    Bari, 70124

  • Local Institution

    Bologna, 40138

  • Local Institution - 0106

    Brescia, Province Of Brescia, 25123

  • Local Institution

    Catania, 95124

  • Local Institution - 0027

    Florence, 50134

  • Local Institution - 0046

    Monza, 20900

  • Local Institution

    Naples, 80131

  • Local Institution - 0025

    Orbassano, 10143

  • Local Institution - 0021

    Roma, 00144

  • Local Institution - 0033

    Rome, 00161

Other trials in Italy

Brazil8 sites

  • Local Institution - 0063

    Campinas, São Paulo, 13083-970

  • Local Institution

    Curitiba, Paraná, 80060-900

  • Local Institution - 0083

    Goiânia, Goiás, 74605-020

  • Local Institution

    Ribeirão Preto, São Paulo, 14048-900

  • Local Institution - 0062

    Rio de Janeiro, 20211-030

  • Local Institution - 0058

    Rio de Janeiro, 20231-050

  • Local Institution - 0111

    Rio de Janeiro, 20231-050

  • Local Institution - 0059

    São Paulo, São Paulo, 08270-070

Other trials in Brazil

Argentina6 sites

  • Local Institution - 0051

    Buenos Aires, 4102-4200

  • Local Institution - 0057

    Buenos Aires, C1114AAN

  • Local Institution - 0100

    Corrientes, CP3400

  • Local Institution - 0093

    La Plata, Buenos Aires, 0

  • Local Institution - 0080

    Ramos Mejía, Buenos Aires, 1221

  • Local Institution - 0049

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Austria6 sites

  • Local Institution

    Fürstenfeld, 8280

  • Local Institution - 0043

    Graz, 8036

  • Local Institution - 0026

    Innsbruck, Tyrol, 6020

  • Local Institution - 0024

    Linz, 4010

  • Local Institution - 0023

    Vienna, 1090 Wien

  • Local Institution - 0022

    Wels, Upper Austria, 4600

Other trials in Austria

Spain6 sites

  • Local Institution - 0017

    A Couruna, 15706

  • Local Institution - 0018

    L'Hospitalet Del Llobregat, 08908

  • Local Institution - 0015

    Las Palmas de Gran Canaria, 35010

  • Local Institution - 0012

    Madrid, 28007

  • Local Institution - 0013

    Salamanca, 37007

  • Local Institution - 0011

    Toledo, 45004

Other trials in Spain

Czechia5 sites

  • Local Institution - 0032

    Brno, Czech Republic, 625 00

  • Local Institution

    Hradec Králové, 500 05

  • Local Institution

    Olomouc, 775 20

  • Local Institution

    Prague, 100 34

  • Local Institution - 0067

    Prague, 12808

Other trials in Czechia

France5 sites

  • Local Institution - 0045

    Le Chesnay, 78157

  • Local Institution - 0041

    Lille, 59037

  • Local Institution

    Nantes, 44000

  • Local Institution

    Pierre-Bénite, 69495

  • Local Institution - 0038

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Poland4 sites

  • Local Institution - 0047

    Gdansk, 80-952

  • Local Institution - 0098

    Katowice, 40-032

  • Local Institution - 0048

    Krakow, Lesser Poland Voivodeship, 30-510

  • Local Institution - 0064

    Warsaw, 02-776

Other trials in Poland

Belgium3 sites

  • Local Institution - 0065

    Bruges, B-8000

  • Local Institution - 0099

    Merksem, 2170

  • Local Institution

    Yvoir, 5530

Other trials in Belgium

South Korea3 sites

  • Local Institution - 0039

    Seoul, 06351

  • Local Institution - 0050

    Seoul, 137-701

  • Local Institution - 0040

    Seoul, 138-736

Other trials in South Korea

Thailand3 sites

  • Local Institution

    Bangkok, 10400

  • Local Institution - 0052

    Khon Kaen, 40002

  • Local Institution - 0055

    Muang, Chiang Mai, 50200

Other trials in Thailand

Hungary2 sites

  • Local Institution

    Budapest, 1083

  • Local Institution - 0104

    Szeged, 6725

Other trials in Hungary

Canada1 site

  • Local Institution - 0020

    Saint John, New Brunswick, E2L 4L2

Other trials in Canada

About this study

Official 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

The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

Being tested
Imatinib, Dasatinib
Medical subject headings
Leukemia, Myeloid, Chronic-Phase

What participants receive

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

  • ImatinibDrug

    Also called Gleevec, Glivec

  • DasatinibDrug

    Also called Sprycel

Study groups in NCT01593254
Study groupRoleWhat they receive
Arm 1: Imatinib (≥400 mg)Active comparatorImatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months
Receives: Drug: Imatinib
Arm 2: Dasatinib (100 mg)Active comparatorDasatinib 100 mg tablet by mouth QD up to 60 months
Receives: Drug: Dasatinib

What is being measured

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

  1. Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment

    Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals.

    P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (<=4 weeks vs >4 weeks).

    Measured: At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib.

Secondary outcomes (4)

  1. Median Time to Major Molecular Response (MMR)

    Median Time to Major Molecular Response (MMR) is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored.

    Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR.

    Measured: From randomization to study completion. Approximately 115 months

  2. Time to Molecular Response (MR)^4.5

    Time to Molecular Response (MR)^4.5 is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored.

    MR4.5 is defined as a 4.5-log reduction in BCR-ABL transcript from the standardized baseline (0.0032% IS, either detectable disease <= 0.0032% BCR-ABL (IS) or undetectable disease in cDNA (in same volume used for BCR-ABL) with >= 32,000 ABL transcripts.

    Measured: From randomization to study completion. Approximately 115 months

  3. Progression Free Survival (PFS)

    PFS is the time from randomization date to progression date or death date, whichever occurs first. Participants who neither progress nor die will be censored.

    Progression is defined as the following, meeting the criteria for accelerated or blast crisis CML are met at any time or death from any cause during treatment.

    Accelerated phase of CML:

    • The presence of ≥15%, but < 30% blasts in the blood or bone marrow
    • At least 30% blasts plus promyelocytes in the blood or bone marrow
    • At least 20% peripheral basophils
    • Thrombocytopenia (fewer than 100,000 platelets/mm3) unrelated to treatment.

    Blast phase of CML

    • At least 30% blasts in the blood or bone marrow
    • Extramedullary involvement (e.g., chloromas), but not hepatosplenomegaly

    Measured: From randomization to study completion. Approximately 115 months

  4. Overall Survival (OS)

    OS is the time from randomization date to death date. Participants who have not died will be censored on the last date they are known to be alive.

    Measured: From randomization to study completion. Approximately 115 months

Timeline

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

  1. First posted8 May 2012 (estimated)
  2. Study start12 Sep 2012
  3. Primary completion8 Nov 2017
  4. Study completion12 Apr 2022

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01593254
Sponsor's protocol ID
CA180-399
Other IDs
2011-006181-41
Acronym
DASCERN
Status last verified
May 2023
First submitted
4 May 2012
Last updated
22 Jun 2023
Data monitoring committee
Yes

Publications

  • Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Gurnani R, Saglio G. Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study. Leukemia. 2020 Aug;34(8):2064-2073. doi: 10.1038/s41375-020-0805-1. Epub 2020 Apr 7.

    PubMed 32265500

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imatinib and Dasatinib in people with Chronic Phase Chronic Myeloid Leukemia, run by Bristol-Myers Squibb at 101 sites in 15 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 5 inclusion and 5 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, China, Italy, Brazil, Argentina and 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Apr 2019). 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?

Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment (time frame: At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib.). 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 NCT01593254, which also lists 1 linked publication.

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 22 Jun 2023.

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