Leukemia, Myeloid, ChronicPhase 2NCT00298987
A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate
A Phase 2 study testing Dasatinib in people with Leukemia, Myeloid, Chronic and Leukemia, Lymphocytic, Acute, L2, run by Bristol-Myers Squibb at 35 sites in 2 countries.
Trial summary
The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Chronic, Leukemia, Lymphocytic, Acute, L2
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Feb 2006to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Diagnosis of accelerated phase or blast phase CML or Ph+ ALL
- Intolerant or resistant to imatinib mesylate
- 18 years of age or older
- ECOG performance 0-2 (greater than 50% of time out of bed)
- Adequate liver and kidney function
Who cannot join
- Pregnant or breastfeeding females
- History of significant cardiac disease
- History of significant bleeding disorder (not CML)
- Prisoners
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States30 sites
Local Institution
Ann Arbor, Michigan
Local Institution
Atlanta, Georgia
Local Institution
Aurora, Colorado
Local Institution
Beach Grove, Indiana
Local Institution
Boston, Massachusetts
Local Institution
Charleston, South Carolina
Local Institution
Chattanooga, Tennessee
Local Institution
Cincinnati, Ohio
Local Institution
Cleveland, Ohio
Local Institution
Colorado Springs, Colorado
Local Institution
Corona, California
Local Institution
Daytona Beach, Florida
Local Institution
Detroit, Michigan
Local Institution
Indianapolis, Indiana
Local Institution
Iowa City, Iowa
Local Institution
Jupiter, Florida
Local Institution
Kansas City, Kansas
Local Institution
Lawrenceville, Georgia
Local Institution
Lawton, Oklahoma
Local Institution
Lexington, Kentucky
Local Institution
Louisville, Kentucky
Local Institution
New York, New York
Local Institution
Portland, Oregon
Local Institution
Providence, Rhode Island
Local Institution
Salina, Kansas
Local Institution
Santa Fe, New Mexico
Local Institution
Sheboygan, Wisconsin
Local Institution
Spokane, Washington
Local Institution
Tulsa, Oklahoma
Local Institution
Waterford, Connecticut
Canada5 sites
Local Institution
Edmonton, Alberta
Local Institution
Hamilton, Ontario
Local Institution
Montreal, Quebec
Local Institution
Toronto, Ontario
Local Institution
Vancouver, British Columbia
About this study
Official title: Study of Dasatinib (BMS-354825) in Subjects With Chronic Myelogenous Leukemia With Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant to or Intolerant of Imatinib Mesylate
The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.
- Being tested
- Dasatinib
- Keywords
- Chronic Myeloid Leukemia Accelerated and Blast Phase, Leukemia, Acute, Philadelphia-Positive
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Blast Crisis, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called Sprycel
Tablets, Oral, 70 mg, Twice daily, 2 months.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provide therapy to patients for which there is no therapeutic alternative
Secondary outcomes (1)
Safety data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, ChronicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
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
- NCT00298987
- Sponsor's protocol ID
- CA180-033
- Status last verified
- Jun 2008
- First submitted
- 2 Mar 2006
- Last updated
- 8 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Dasatinib (BMS-354825) in Subjects With Chronic Myelogenous Leukemia With Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant to or Intolerant of Imatinib Mesylate
- ClinicalTrials.gov ID
- NCT00298987
- Acronym / sponsor ID
- CA180-033
- Keywords
- Chronic Myeloid Leukemia Accelerated and Blast Phase, Leukemia, Acute, Philadelphia-Positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 6 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Dasatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of accelerated phase or blast phase CML or Ph+ ALL
- Intolerant or resistant to imatinib mesylate
- 18 years of age or older
- ECOG performance 0-2 (greater than 50% of time out of bed)
- Adequate liver and kidney function
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding females
- History of significant cardiac disease
- History of significant bleeding disorder (not CML)
- Prisoners
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: SprycelTablets, Oral, 70 mg, Twice daily, 2 months. | Drug | A1 |
Primary outcome
Provide therapy to patients for which there is no therapeutic alternative
1 secondary outcome
Safety data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2010.
Related trials for Leukemia, Myeloid, Chronic
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
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib in people with Leukemia, Myeloid, Chronic and Leukemia, Lymphocytic, Acute, L2, run by Bristol-Myers Squibb at 35 sites in 2 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 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 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Provide therapy to patients for which there is no therapeutic alternative. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2010.