Chronic Myeloid LeukemiaPhase 2NCT00103844
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
A Phase 2 study testing Dasatinib and Imatinib in people with Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia, run by Bristol-Myers Squibb at 131 sites in 32 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia
- 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
- 150 participants
- Where
- 131 sitesin 32 countries
- Study dates
- Feb 2005to Mar 2008
- 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
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
131 sites in 32 countries.
131 sites in 32 countries
United States53 sites
Local Institution
Anaheim, California
Local Institution
Athens, Georgia
Local Institution
Atlanta, Georgia
Local Institution
Aurora, Colorado
Local Institution
Bakersfield, California
Local Institution
Birmingham, Alabama
Local Institution
Boston, Massachusetts
Local Institution
Cary, North Carolina
Local Institution
Chapel Hill, North Carolina
Local Institution
Chicago, Illinois
Local Institution
Columbia, Missouri
Local Institution
Dallas, Texas
Local Institution
Fort Worth, Texas
Local Institution
Fullerton, California
Local Institution
Greenville, South Carolina
Local Institution
Hackensack, New Jersey
Local Institution
Hartford, Connecticut
Local Institution
Houston, Texas
Local Institution
Indianapolis, Indiana
Local Institution
Jacksonville, Florida
Local Institution
Kansas City, Kansas
Local Institution
Kansas City, Missouri
Local Institution
Lawrenceville, Georgia
Local Institution
Lexington, Kentucky
Local Institution
Loma Linda, California
Local Institution
Los Angeles, California
Local Institution
Minneapolis, Minnesota
Local Institution
Monterey Park, California
Local Institution
Morristown, New Jersey
Local Institution
Nashville, Tennessee
Local Institution
New Brunswick, New Jersey
Local Institution
Norfolk, Virginia
Local Institution
Oklahoma City, Oklahoma
Local Institution
Omaha, Nebraska
Local Institution
Peoria, Illinois
Local Institution
Pittsburgh, Pennsylvania
Local Institution
Portland, Oregon
Local Institution
Rochester, Minnesota
Local Institution
San Antonio, Texas
Local Institution
San Diego, California
Local Institution
Santa Barbara, California
Local Institution
Santa Maria, California
Local Institution
Seattle, Washington
Local Institution
Spokane, Washington
Local Institution
St Louis, Missouri
Local Institution
Stanford, California
Local Institution
Tampa, Florida
Local Institution
Tucker, Georgia
Local Institution
Tulsa, Oklahoma
Local Institution
Tyler, Texas
Local Institution
Vallejo, California
Local Institution
Vancouver, Washington
Local Institution
Washington D.C., District of Columbia
France7 sites
Local Institution
Lille
Local Institution
Lyon
Local Institution
Nantes
Local Institution
Paris
Local Institution
Pessac
Local Institution
Poitiers
Local Institution
Strasbourg
Belgium6 sites
Local Institution
B-Leuven
Local Institution
Bruges
Local Institution
Brussels
Local Institution
Charleroi
Local Institution
Edegem
Local Institution
Yvoir
Germany6 sites
Local Institution
Dresden
Local Institution
Groenkloof
Local Institution
Hamburg
Local Institution
Leipzig
Local Institution
Mainz
Local Institution
Mannheim
Italy6 sites
Local Institution
Bari
Local Institution
Bologna
Local Institution
Milan
Local Institution
Naples
Local Institution
Orbassano
Local Institution
Roma
Australia5 sites
Local Institution
Adelaide, South Australia
Local Institution
Camperdown, New South Wales
Local Institution
Perth, Western Australia
Local Institution
South Brisbane, Queensland
Local Institution
St Leonards, New South Wales
Sweden5 sites
Local Institution
Gothenburg
Local Institution
Lund
Local Institution
Stockholm
Local Institution
Umeå
Local Institution
Uppsala
Canada4 sites
Local Institution
Edmonton, Alberta
Local Institution
Montreal, Quebec
Local Institution
Toronto, Ontario
Local Institution
Vancouver, British Columbia
Poland4 sites
Local Institution
Katowice
Local Institution
Krakow
Local Institution
Lublin
Local Institution
Warsaw
Brazil3 sites
Local Institution
Curitiba, Paraná
Local Institution
Rio de Janeiro, Rio de Janeiro
Local Institution
São Paulo, São Paulo
South Africa3 sites
Local Institution
Bloemfontein, Free State
Local Institution
Parktown, Gauteng
Local Institution
Soweto, Gauteng
United Kingdom3 sites
Local Institution
Glasglow, Central
Local Institution
London, Greater London
Local Institution
Newcastle, Tyne and Wear
Argentina2 sites
Local Institution
Buenos Aires, Buenos Aires
Local Institution
Córdoba, Córdoba Province
About this study
Official 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
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.
- Being tested
- Dasatinib, Imatinib
- Keywords
- Chronic Phase Philadelphia chromosome Positive (Ph+) 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, 20 mg and 50mg, twice daily, up to 96 weeks
ImatinibDrug
Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active Comparator Receives: Drug: Dasatinib |
| 2 | Experimental | Active Comparator Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
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).
Measured: Week 12
Secondary outcomes (13)
MCyR at Any Time Prior to Crossover
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).
Measured: Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.
Duration of MCyR at 12 Months and 18 Months
Percentage of participants who achieved MCyR and did not progress at 12 and 18 months.
Measured: 12 months, 18 months
Duration of MCyR at 24 Months
Percentage of participants who achieved MCyR and did not progress at 24 months.
Measured: 24 Months
Time to MCyR Prior to Crossover
Median time from first dosing date to date of MCyR
Measured: Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.
Complete Hematologic Response (CHR) at Any Time Prior to Crossover
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.
Measured: 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.
Duration of Complete Hematologic Response (CHR)
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.
Measured: 12 months, 24 months
Time to CHR Prior to Crossover
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.
Measured: Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.
Major Molecular Response (MMR)
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.
Measured: Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.
CHR After Crossover
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.
Measured: Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.
Cytogenetic Response After Crossover
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).
Measured: every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
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)
Measured: Continuously from baseline through 2 years
Health-Related Quality of Life Prior to Crossover
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.
Measured: 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.
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Number of participants from which blood samples were collected for population PK studies.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2005 (estimated)
- Study startFeb 2005
- Primary completionAug 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103844
- Sponsor's protocol ID
- CA180-017
- Status last verified
- Jun 2010
- First submitted
- 15 Feb 2005
- Last updated
- 10 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 19536906Muller 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.
PubMed 19779040
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00103844
- Acronym / sponsor ID
- CA180-017
- Keywords
- Chronic Phase Philadelphia chromosome Positive (Ph+) chronic myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 16 Feb 2005 (estimated)
- Results
- Posted 7 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DasatinibActive Comparator |
| 2 | Experimental | Drug: ImatinibActive Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAlso: Sprycel, BMS-354825Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks | Drug | 1 |
| ImatinibTablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks | Drug | 2 |
Primary outcome
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
Time frame: Week 12
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).
13 secondary outcomes
MCyR at Any Time Prior to Crossover
Time frame: Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.
Duration of MCyR at 12 Months and 18 Months
Time frame: 12 months, 18 months
Duration of MCyR at 24 Months
Time frame: 24 Months
Time to MCyR Prior to Crossover
Time frame: Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.
Complete Hematologic Response (CHR) at Any Time Prior to Crossover
Time frame: 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.
Duration of Complete Hematologic Response (CHR)
Time frame: 12 months, 24 months
Time to CHR Prior to Crossover
Time frame: Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.
Major Molecular Response (MMR)
Time frame: Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.
CHR After Crossover
Time frame: Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.
Cytogenetic Response After Crossover
Time frame: every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Time frame: Continuously from baseline through 2 years
Health-Related Quality of Life Prior to Crossover
Time frame: 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.
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19536906Kantarjian 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.
- Background: PubMed 19779040Muller 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.
Related trials for Chronic Myeloid Leukemia
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
131 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib and Imatinib in people with Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia, run by Bristol-Myers Squibb at 131 sites in 32 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 7 inclusion and 20 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 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 131 sites in United States, France, Belgium, Germany, Italy and 27 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 7 Jan 2010). 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 Major Cytogenetic Response (MCyR) at Week 12 (time frame: Week 12). 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 NCT00103844, which also lists 2 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 10 Aug 2010.