Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00103844
Registration number
NCT00103844
Ethics application status
Date submitted
15/02/2005
Date registered
16/02/2005
Date last updated
10/08/2010
Titles & IDs
Public title
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
Query!
Scientific title
A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d
Query!
Secondary ID [1]
0
0
CA180-017
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia
0
0
Query!
Philadelphia-Positive Myeloid Leukemia
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Children's - Leukaemia & Lymphoma
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Dasatinib
Treatment: Drugs - Imatinib
Experimental: 1 - Active Comparator
Experimental: 2 - Active Comparator
Treatment: Drugs: Dasatinib
Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks
Treatment: Drugs: Imatinib
Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
Query!
Assessment method [1]
0
0
Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; \>0% to 35% Ph+ cells in metaphase in bone marrow).
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [1]
0
0
MCyR at Any Time Prior to Crossover
Query!
Assessment method [1]
0
0
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as CCyR (0% Ph+ cells in metaphase in bone marrow) or PCyR (\>0% to 35% Ph+ cells in metaphase in bone marrow).
Query!
Timepoint [1]
0
0
Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.
Query!
Secondary outcome [2]
0
0
Duration of MCyR at 12 Months and 18 Months
Query!
Assessment method [2]
0
0
Percentage of participants who achieved MCyR and did not progress at 12 and 18 months.
Query!
Timepoint [2]
0
0
12 months, 18 months
Query!
Secondary outcome [3]
0
0
Duration of MCyR at 24 Months
Query!
Assessment method [3]
0
0
Percentage of participants who achieved MCyR and did not progress at 24 months.
Query!
Timepoint [3]
0
0
24 Months
Query!
Secondary outcome [4]
0
0
Time to MCyR Prior to Crossover
Query!
Assessment method [4]
0
0
Median time from first dosing date to date of MCyR
Query!
Timepoint [4]
0
0
Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.
Query!
Secondary outcome [5]
0
0
Complete Hematologic Response (CHR) at Any Time Prior to Crossover
Query!
Assessment method [5]
0
0
Participants achieving CHR prior to crossover. CHR=all of the following criteria: white blood cell count = institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils = 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at = Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Query!
Timepoint [5]
0
0
Baseline (within 4 weeks of Day 1), weekly until Week 12 and then every 12 weeks until crossover or off-study; restricted to precrossover measurements.
Query!
Secondary outcome [6]
0
0
Duration of Complete Hematologic Response (CHR)
Query!
Assessment method [6]
0
0
Percentage of participants who achieved CHR and did not progress at specified time points. CHR=all of the following criteria: white blood cell count = institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils = 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at = Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Query!
Timepoint [6]
0
0
12 months, 24 months
Query!
Secondary outcome [7]
0
0
Time to CHR Prior to Crossover
Query!
Assessment method [7]
0
0
Median time from first dosing date to date of CHR. CHR=all of the following criteria: white blood cell count = institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils = 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at = Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Query!
Timepoint [7]
0
0
Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.
Query!
Secondary outcome [8]
0
0
Major Molecular Response (MMR)
Query!
Assessment method [8]
0
0
Number of participants Achieving MMR. MMR is defined as =3 log reduction (ie, international ratio =0.1), in BCR-ABL levels from the standardized baseline value of BCR-ABL: Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL: Control gene ratio by the lab-specific conversion factor.
Query!
Timepoint [8]
0
0
Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.
Query!
Secondary outcome [9]
0
0
CHR After Crossover
Query!
Assessment method [9]
0
0
Participants achieving CHR after crossover. CHR=all of the following criteria: white blood cell count = institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils = 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at = Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Query!
Timepoint [9]
0
0
Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.
Query!
Secondary outcome [10]
0
0
Cytogenetic Response After Crossover
Query!
Assessment method [10]
0
0
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (0% Ph+ cells in metaphase in bone marrow) or Partial CyR (\>0% to 35% Ph+ cells in metaphase in bone marrow).
Query!
Timepoint [10]
0
0
every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements
Query!
Secondary outcome [11]
0
0
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Query!
Assessment method [11]
0
0
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
Query!
Timepoint [11]
0
0
Continuously from baseline through 2 years
Query!
Secondary outcome [12]
0
0
Health-Related Quality of Life Prior to Crossover
Query!
Assessment method [12]
0
0
Health-related quality of life as measured by Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G=27 questions in 4 domains: physical, social/family, emotional, \& functional well-being (PWB, SWB, EWB, FWB). Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, \& FWB score change of 3 or more, \& SWB score change of 2 or more=minimal clinical important change.
Query!
Timepoint [12]
0
0
Every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment. Last questionnaire was to be completed at first follow-up visit after off-study date.
Query!
Secondary outcome [13]
0
0
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Query!
Assessment method [13]
0
0
Number of participants from which blood samples were collected for population PK studies.
Query!
Timepoint [13]
0
0
Day 8: pretreatment trough sample, a sample between 30 minutes and 3 hours following treatment, a sample between 5 and 8 hours following treatment, and a sample at 12 hours, prior to the next dose.
Query!
Eligibility
Key inclusion criteria
* Men and women, 18 years of age or older.
* Subjects with Chronic Phase Ph+ CML.
* Subjects have not been treated with imatinib at a dose >600 mg/day.
* Subjects developed resistance to disease while receiving an imatinib dose 400-600 mg/day.
* Able to tolerate imatinib at the highest dose the subject had received in the past.
* Demonstrate adequate renal and hepatic function.
* Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study.
* Women using a prohibited contraceptive method.
* Women who are pregnant or breastfeeding.
* Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above.
* Prior treatment with imatinib at a dose >600 mg/day.
* Subjects who have previously identified specific BCR-ABL mutations.
* Previous diagnosis of accelerated phase or blast crisis CML.
* Intolerance to imatinib at any dose.
* Subjects who are eligible and willing to undergo transplantation during the screening period.
* Serious uncontrolled medical disorder or active infection.
* Uncontrolled or significant cardiovascular disease.
* Uncontrolled hypertension.
* Dementia or altered mental status.
* Evidence of organ dysfunction.
* Use of imatinib within 7 days.
* Use of interferon or cytarabine within 14 days.
* Use of a targeted small molecule anticancer agent within 14 days.
* Subjects taking certain medications that are accepted to have a risk of causing Torsades de Pointes.
* Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
* Prior therapy with BMS-354825.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
150
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - Camperdown
Query!
Recruitment hospital [2]
0
0
Local Institution - St. Leonards
Query!
Recruitment hospital [3]
0
0
Local Institution - South Brisbane
Query!
Recruitment hospital [4]
0
0
Local Institution - Adelaide
Query!
Recruitment hospital [5]
0
0
Local Institution - Perth
Query!
Recruitment postcode(s) [1]
0
0
- Camperdown
Query!
Recruitment postcode(s) [2]
0
0
- St. Leonards
Query!
Recruitment postcode(s) [3]
0
0
- South Brisbane
Query!
Recruitment postcode(s) [4]
0
0
- Adelaide
Query!
Recruitment postcode(s) [5]
0
0
- Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kansas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kentucky
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Minnesota
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nebraska
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oklahoma
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oregon
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Virginia
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Washington
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Buenos Aires
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Cordoba
Query!
Country [28]
0
0
Austria
Query!
State/province [28]
0
0
Wein
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
B-Leuven
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Brugge
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Bruxelles
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Charleroi
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Edegem
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Yvoir
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Parana
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Rio De Janeiro
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Sao Paulo
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Alberta
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
British Columbia
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Ontario
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Quebec
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Beijing
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Shanghai
Query!
Country [44]
0
0
Denmark
Query!
State/province [44]
0
0
Aarhus
Query!
Country [45]
0
0
Estonia
Query!
State/province [45]
0
0
Tallin
Query!
Country [46]
0
0
Finland
Query!
State/province [46]
0
0
Helsinki
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Lille
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Lyon Cedex 03
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Nantes
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Paris
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Pessac
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Poitiers
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Strasbourg Cedex
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Dresden
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Groenkloof
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Hamburg
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Leipzig
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Mainz
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Mannheim
Query!
Country [60]
0
0
Hungary
Query!
State/province [60]
0
0
Budapest
Query!
Country [61]
0
0
Ireland
Query!
State/province [61]
0
0
Dublin
Query!
Country [62]
0
0
Israel
Query!
State/province [62]
0
0
Ramat-Gan
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Bari
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Bologna
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Milano
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Napoli
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Orbassano
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Roma
Query!
Country [69]
0
0
Korea, Republic of
Query!
State/province [69]
0
0
Kyunggi-Do
Query!
Country [70]
0
0
Norway
Query!
State/province [70]
0
0
Trondheim
Query!
Country [71]
0
0
Peru
Query!
State/province [71]
0
0
Lima
Query!
Country [72]
0
0
Philippines
Query!
State/province [72]
0
0
Quezon City
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Katowice
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Krakow
Query!
Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Lublin
Query!
Country [76]
0
0
Poland
Query!
State/province [76]
0
0
Warsaw
Query!
Country [77]
0
0
Puerto Rico
Query!
State/province [77]
0
0
San Juan
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Moscow
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
St. Petersburg
Query!
Country [80]
0
0
Singapore
Query!
State/province [80]
0
0
Singapore
Query!
Country [81]
0
0
South Africa
Query!
State/province [81]
0
0
Free State
Query!
Country [82]
0
0
South Africa
Query!
State/province [82]
0
0
Gauteng
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Barcelona
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Madrid
Query!
Country [85]
0
0
Sweden
Query!
State/province [85]
0
0
Gothenburg
Query!
Country [86]
0
0
Sweden
Query!
State/province [86]
0
0
Lund
Query!
Country [87]
0
0
Sweden
Query!
State/province [87]
0
0
Stockholm
Query!
Country [88]
0
0
Sweden
Query!
State/province [88]
0
0
Umea
Query!
Country [89]
0
0
Sweden
Query!
State/province [89]
0
0
Uppsala
Query!
Country [90]
0
0
Switzerland
Query!
State/province [90]
0
0
Basel
Query!
Country [91]
0
0
Switzerland
Query!
State/province [91]
0
0
Bellinzona
Query!
Country [92]
0
0
Taiwan
Query!
State/province [92]
0
0
Taipei
Query!
Country [93]
0
0
Taiwan
Query!
State/province [93]
0
0
Taoyuan
Query!
Country [94]
0
0
Thailand
Query!
State/province [94]
0
0
Bangkok
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Central
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
Greater London
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Tyne and Wear
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00103844
Query!
Trial related presentations / publications
Kantarjian H, Pasquini R, Levy V, Jootar S, Holowiecki J, Hamerschlak N, Hughes T, Bleickardt E, Dejardin D, Cortes J, Shah NP. Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia resistant to imatinib at a dose of 400 to 600 milligrams daily: two-year follow-up of a randomized phase 2 study (START-R). Cancer. 2009 Sep 15;115(18):4136-47. doi: 10.1002/cncr.24504. Muller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00103844
Download to PDF