Chronic Myeloid LeukemiaPhase 2/3NCT00349518
Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL
A Phase 2/3 study testing Dasatinib in people with Chronic Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Bristol-Myers Squibb at 20 sites in 6 countries.
Trial summary
The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- Dasatinib
- How many people
- 0 participants
- Where
- 20 sitesin 6 countries
- Study dates
- Dec 2006to Jan 2007
- Phase
- Phase 2/3
- 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
- Adult, Older adult
Who may be able to join
- Males and females, 18 or older
- CP or AD CML or Ph+ ALL
- Intolerant of resistant to imatinib
- ECOG PS 0-2 (CP CML)
- ECOG PS 0-3 (AD CML and Ph+ ALL)
- Adequate hepatic and renal function
Who cannot join
- Pregnant or breastfeeding females
- History of significant cardiac disease
- History of significant bleeding disorder (not CML)
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
Poland6 sites
Local Institution
Gdansk
Local Institution
Katowice
Local Institution
Krakow
Local Instiution
Lodz
Local Institution
Lublin
Local Institution
Warsaw
United Kingdom6 sites
Local Institution
Birmingham, West Midlands
Local Institution
Cambridge, Cambridgeshire
Local Institution
Glasgow, Central
Local Institution
Liverpool, Merseyside
Local Institution
London, Greater London
Local Institution
Newcastle, Tyne and Wear
Italy3 sites
Local Institution
Bologna
Local Institution
Orbassano (To)
Local Institution
Roma
About this study
Official title: A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib
The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.
- Being tested
- Dasatinib
- Keywords
- Chronic and Advanced Phase CML and, Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of drug-related adverse events.
Secondary outcomes (3)
Chronic Phase CML: Cytogenetic and Hematologic Response
Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
Time to and duration of Cytogenetic and Hematologic Response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startDec 2006
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT00349518
- Sponsor's protocol ID
- CA180-083
- Other IDs
- EUDRACTnr: 2006-001279-39
- Status last verified
- Apr 2011
- First submitted
- 6 Jul 2006
- Last updated
- 17 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib
- ClinicalTrials.gov ID
- NCT00349518
- Acronym / sponsor ID
- CA180-083
- Keywords
- Chronic and Advanced Phase CML and, Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2007 (actual)
- First posted
- 7 Jul 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 study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females, 18 or older
- CP or AD CML or Ph+ ALL
- Intolerant of resistant to imatinib
- ECOG PS 0-2 (CP CML)
- ECOG PS 0-3 (AD CML and Ph+ ALL)
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding females
- History of significant cardiac disease
- History of significant bleeding disorder (not CML)
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 |
|---|---|---|
| Dasatinib | Drug | – |
Primary outcome
Incidence and severity of drug-related adverse events.
3 secondary outcomes
Chronic Phase CML: Cytogenetic and Hematologic Response
Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
Time to and duration of Cytogenetic and Hematologic Response
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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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
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dasatinib in people with Chronic Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Bristol-Myers Squibb at 20 sites in 6 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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Poland, United Kingdom, Italy, Netherlands, Russia and 1 more country. 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 combined 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence and severity of drug-related adverse events.. 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 17 Feb 2016.