LeukemiaPhase 2START rolloverNCT00982488
Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
A Phase 2 study testing Dasatinib and Imatinib in people with Leukemia, run by Bristol-Myers Squibb at 72 sites in 24 countries.
Trial summary
This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 238 participants
- Where
- 72 sitesin 24 countries
- Study dates
- Oct 2007to Dec 2014
- 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
- Signed written informed consent
- Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
- Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
- Men and women, ages 18 and older
Who cannot join
- A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
- Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)
Trial locations and contacts
72 sites in 24 countries.
72 sites in 24 countries
United States17 sites
Pacific Cancer Medical Center Inc
Anaheim, California, 92801
University Of Michigan Medical Center
Ann Arbor, Michigan, 48109
Dana Faber Cancer Institute
Boston, Massachusetts, 02215
University Of Chicago
Chicago, Illinois, 60637
Ut Southwestern Medical Center At Dallas
Dallas, Texas, 75390
Wayne State University
Detroit, Michigan, 48201
John Theurer Cancer Center
Hackensack, New Jersey, 07601
The University Of Texas Md Anderson Cancer Center
Houston, Texas, 77030
Central Indiana Cancer Centers
Indianapolis, Indiana, 46219
Loma Linda University Cancer Center
Loma Linda, California, 92354
Ucla Department Of Medicine
Los Angeles, California, 90095
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Oregon Health & Sci Univ
Portland, Oregon, 97239
Stanford University School Of Medicine
Stanford, California, 94305
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Kaiser Permanente Medical Center
Vallejo, California, 94589
University Of Kansas Medical Center
Westwood, Kansas, 66205
France7 sites
Local Institution
Lille, 59000
Local Institution
Lyon, 69437
Local Institution
Nantes, 44035
Local Institution
Paris, 75475
Local Institution
Pessac, 33604
Local Institution
Poitiers, 86021
Local Institution
Strasbourg, 67091
Brazil5 sites
Local Institution
Campinas, São Paulo, 13083
Local Institution
Curitiba, Paraná, 80060
Local Institution
Rio de Janeiro, Rio de Janeiro, 20231
Local Institution
São Paulo, São Paulo, 05403
Local Institution
São Paulo, São Paulo, 05652
Poland5 sites
Local Institution
Katowice, 40032
Local Institution
Krakow, 31501
Local Institution
Lodz, 93-510
Local Institution
Lublin, 20081
Local Institution
Warsaw, 02097
Sweden5 sites
Local Institution
Gothenburg, 41345
Local Institution
Lund, 221 85
Local Institution
Stockholm, SE-17176
Local Institution
Umeå, 901 85
Local Institution
Uppsala, 751 85
Italy4 sites
Local Institution
Bologna, 40138
Local Institution
Naples, 80131
Local Institution
Orbassano (to), 10043
Local Institution
Roma, 00144
Argentina3 sites
Local Institution
Buenos Aires, Buenos Aires, 1021
Local Institution
Buenos Aires, Buenos Aires, 1280
Local Institution
Capital Federal, Buenos Aires, 1425
Germany3 sites
Local Institution
Hamburg, 20246
Local Institution
Leipzig, 04103
Local Institution
Mannheim, 68167
United Kingdom3 sites
Local Institution
Glasgow, Scotland, G12 OXB
Local Institution
London, Greater London, W12 OHS
Local Institution
Newcastle, Tyne and Wear, NE2 4HH
Canada2 sites
Local Institution
Montreal, Quebec, H3A 1A1
Local Institution
Toronto, Ontario, M4X 1K9
Peru2 sites
Local Institution
Lima, Lima Province, 34
Local Institution
Lima, Lima Province, LIMA II
Russia2 sites
Local Institution
Moscow, 125167
Local Institution
Saint Petersburg, 179089
South Africa2 sites
Local Institution
Groenkloof, Gauteng, 0181
Local Institution
Parktown, Gauteng, 2193
South Korea2 sites
Local Institution
Jeollanam-do, 519-809
Local Institution
Seoul, 137-040
About this study
Official title: Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis
This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called BMS-354825, Sprycel, Src Kinase
Dasatinib was supplied as 20- and 50-mg tablets.
ImatinibDrug
Also called Gleevec/Glivec
Imatinib was supplied as 100- and 400-mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib, 50 mg QD to 120 mg BID, Chronic phase | Other | Participants with chronic phase disease continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Receives: Drug: Dasatinib |
| Imatinib, 400 mg BID, Chronic phase | Other | Participants with chronic phase disease received 400 mg of imatinib twice BID. Receives: Drug: Imatinib |
| Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP | Other | Participants with advanced phase disease, accelerated phase (AP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Receives: Drug: Dasatinib |
| Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP | Other | Participants with advanced phase disease, myeloid blast cell (MBP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Receives: Drug: Dasatinib |
| Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL | Other | Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.
Measured: Day 1 of treatment through a maximum of 82 months + 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startOct 2007
- Primary completionDec 2014
- Study completionDec 2014
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.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982488
- Sponsor's protocol ID
- CA180-188
- Other IDs
- 2007-003624-37
- Acronym
- START rollover
- Status last verified
- Dec 2015
- First submitted
- 16 Sep 2009
- Last updated
- 22 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis
- ClinicalTrials.gov ID
- NCT00982488
- Acronym / sponsor ID
- START rollover / CA180-188
- Conditions
- Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Posted 22 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dasatinib, 50 mg QD to 120 mg BID, Chronic phase | Other | Drug: DasatinibParticipants with chronic phase disease continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). |
| Imatinib, 400 mg BID, Chronic phase | Other | Drug: ImatinibParticipants with chronic phase disease received 400 mg of imatinib twice BID. |
| Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP | Other | Drug: DasatinibParticipants with advanced phase disease, accelerated phase (AP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. |
| Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP | Other | Drug: DasatinibParticipants with advanced phase disease, myeloid blast cell (MBP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. |
| Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL | Other | Drug: DasatinibParticipants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent
- Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
- Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
- Men and women, ages 18 and older
Key exclusion criteria (4 listed)
- A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
- Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)
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: BMS-354825, Sprycel, Src KinaseDasatinib was supplied as 20- and 50-mg tablets. | Drug | Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP, Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP, Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL, Dasatinib, 50 mg QD to 120 mg BID, Chronic phase |
| ImatinibAlso: Gleevec/GlivecImatinib was supplied as 100- and 400-mg tablets. | Drug | Imatinib, 400 mg BID, Chronic phase |
Primary outcome
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
Time frame: Day 1 of treatment through a maximum of 82 months + 30 days
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
72 sites in 24 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 Leukemia, run by Bristol-Myers Squibb at 72 sites in 24 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 4 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 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, France, Brazil, Poland, Sweden and 19 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 22 Jan 2016). 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 Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest (time frame: Day 1 of treatment through a maximum of 82 months + 30 days). 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 22 Jan 2016.