LeukemiaPhase 3NCT00362466
A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
A Phase 3 study testing Dasatinib and Imatinib in people with Leukemia, run by Bristol-Myers Squibb at 45 sites in United States.
Trial summary
The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this 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
- 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
- 3 participants
- Where
- 45 sitesUnited States
- Study dates
- Apr 2007to Jun 2008
- Phase
- Phase 3
- 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 diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg
- Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis
- Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
- Adequate hepatic and renal function
Who cannot join
- Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant
- Previous diagnosis of accelerated/blast crisis CML
- Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases
- Previous documentation of T315I mutation
- Uncontrolled or significant cardiovascular disease
- Serious uncontrolled medical disorder/active infection
Show all 9Show fewer
- History of significant bleeding disorder unrelated to CML
- Intolerance to imatinib ≥400 mg
- Concurrent malignancies other than CML
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Local Institution
Alhambra, California, 91801
Local Institution
Anaheim, California, 92801
Local Institution
Ann Arbor, Michigan, 48109
Local Institution
Aurora, Colorado, 80045
Local Institution
Baltimore, Pennsylvania, 21229
Local Institution
Beverly Hills, California, 90211
Local Institution
Buffalo, New York, 14263
Local Institution
Chicago, Illinois, 60637
Local Institution
Cleveland, Ohio, 44195
Local Institution
Dallas, Texas, 75390
Local Institution
Durham, North Carolina, 27710
Local Institution
Fullerton, California, 92835
Local Institution
Hackensack, New Jersey, 07601
Local Institution
Hazard, Kentucky, 41701
Local Institution
Houston, Texas, 77030
Dr. Marshall Schreeder
Huntsville, Alabama, 35805
Local Institution
Indianapolis, Indiana, 46202
Local Institution
Jacksonville, Florida, 32207
Local Institution
Jacksonville, Florida, 32209
Local Institution
Kansas City, Kansas, 66160
Local Institution
La Jolla, California, 92093
Local Institution
La Verne, California, 91750
Local Institution
Las Vegas, Nevada, 89135
Local Institution
Little Rock, Arkansas, 72205
Local Institution
Long Beach, California, 90813
Local Institution
Los Angeles, California, 90033
Local Institution
Los Angeles, California, 90048
Local Institution
Los Angeles, California, 90095
New York Presbyterian Hospital
New York, New York, 10021
Local Institution
Northridge, California, 91325
Local Institution
Oklahoma City, Oklahoma, 73112
Local Institution
Omaha, Nebraska, 68114
M.D. Anderson Cancer Center Orlando
Orlando, Florida, 32806
Local Institution
Oxnard, California, 93030
Local Institution
Pembroke Pines, Florida, 33028
Local Institution
Pittsburgh, Pennsylvania, 15232
Local Institution
Redondo Beach, California, 90277
Local Institution
Rochester, Minnesota, 55905
Local Institution
San Francisco, California, 94143
Local Institution
Santa Maria, California, 93454
Local Institution
St Louis, Missouri, 63110
Local Institution
Stanford, California, 94305
Santee Hematology/Oncology
Sumter, South Carolina, 29150
Local Institution
Tulsa, Oklahoma, 74136
New York Medical College
Valhalla, New York, 10595
About this study
Official title: An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib
The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.
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, Once daily, 5-7 years
ImatinibDrug
Tablets, Oral, Once daily, 5-7 years
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 50-180 mg once daily (QD) Receives: Drug: Dasatinib |
| B | Active comparator | 200-800 mg QD Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Cytogenetic Response (CCyR) Rate at Month 6
Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.
Measured: Month 6
Secondary outcomes (7)
Major Molecular Response (MMR) Rates
MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene.
Measured: Month 3, Month 6, Month 12, Month 24 and Month 36
CCyR Rates
CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.
Measured: Month 3, Month 12, Month 24 and Month 36
Estimate Time to MMR and CCyR
Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR.
Measured: throughout the study
Progression Free Survival (PFS)
PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization.
Measured: at 36 months
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Measured: From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.
Duration of CCyR and MMR
Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death.
Measured: Throughout the study
Best MMR Rates
MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene.
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startApr 2007
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Insufficient Enrollment
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT00362466
- Sponsor's protocol ID
- CA180-044
- Status last verified
- Nov 2009
- First submitted
- 9 Aug 2006
- Last updated
- 20 Nov 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib
- ClinicalTrials.gov ID
- NCT00362466
- Acronym / sponsor ID
- CA180-044
- Conditions
- Leukemia
- Keywords
- Leukemia (chronic myeloid leukemia - chronic phase)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Aug 2006 (estimated)
- Results
- Posted 3 Sep 2009
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 compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Dasatinib50-180 mg once daily (QD) |
| B | Active comparator | Drug: Imatinib200-800 mg QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg
- Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis
- Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
- Adequate hepatic and renal function
Key exclusion criteria (9 listed)
- Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant
- Previous diagnosis of accelerated/blast crisis CML
- Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases
- Previous documentation of T315I mutation
- Uncontrolled or significant cardiovascular disease
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®Tablets, Oral, Once daily, 5-7 years | Drug | A |
| ImatinibTablets, Oral, Once daily, 5-7 years | Drug | B |
Primary outcome
Complete Cytogenetic Response (CCyR) Rate at Month 6
Time frame: Month 6
Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.
7 secondary outcomes
Major Molecular Response (MMR) Rates
Time frame: Month 3, Month 6, Month 12, Month 24 and Month 36
CCyR Rates
Time frame: Month 3, Month 12, Month 24 and Month 36
Estimate Time to MMR and CCyR
Time frame: throughout the study
Progression Free Survival (PFS)
Time frame: at 36 months
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Time frame: From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.
Duration of CCyR and MMR
Time frame: Throughout the study
Best MMR Rates
Time frame: throughout study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
- 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
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dasatinib and Imatinib in people with Leukemia, run by Bristol-Myers Squibb at 45 sites in United States.
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 9 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: stopped early, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 3 Sep 2009). 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?
Complete Cytogenetic Response (CCyR) Rate at Month 6 (time frame: Month 6). 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 20 Nov 2009.