Leukemia, Myeloid, ChronicPhase 1NCT00732186
Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
A Phase 1 study testing Ipilimumab in people with Leukemia, Myeloid, Chronic, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Chronic
- What is being tested?
- Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 2011
- Phase
- Phase 1
- 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
- Ph+ CML on dasatinib therapy
- Loss of cytogenetic or molecular response while on dasatinib therapy
- On stable dose of dasatinib for a minimum of 12 weeks and with < 14 day interruption of treatment
Who cannot join
- Blast crisis CML
- Autoimmune disease
- Uncontrolled or significant cardiovascular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
The University Of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase Ib Study Evaluating the Safety and Exploring the Molecular and Cytogenetic Response of Combination Therapy With Dasatinib and Ipilimumab in Patients With Chronic or Accelerated Phase Chronic Myeloid Leukemia
The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML
- Conditions
- Leukemia, Myeloid, Chronic
- Being tested
- Ipilimumab
- 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.
IpilimumabBiological
Also called BMS-734016, MDX-010
IV Solution, IV, 10 mg/kg, (if dose reduction necessary at 3 mg/kg), Every three weeks for the first 10 weeks, with a booster at week 22, Up to 38 weeks depending on response
| Study group | Role | What they receive |
|---|---|---|
| Group 1 and Group 2 | Experimental | Not described Receives: Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of ipilimumab in combination with dasatinib in CML patients with a loss of previously achieved major molecular response or a loss of previously achieved cytogenetic response to dasatinib
Measured: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
Secondary outcomes (3)
To evaluate the frequency of molecular response, complete cytogenetic response and an overall efficacy signal response rate
Measured: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
To explore the immunologic responses to combination therapy with ipilimumab and dasatinib
Measured: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
To explore whether molecular responses to combination therapy with ipilimumab and dasatinib correlate with immunologic responses
Measured: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startAug 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- NCT00732186
- Sponsor's protocol ID
- CA184-033
- Status last verified
- Nov 2009
- First submitted
- 7 Aug 2008
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- 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
- Phase Ib Study Evaluating the Safety and Exploring the Molecular and Cytogenetic Response of Combination Therapy With Dasatinib and Ipilimumab in Patients With Chronic or Accelerated Phase Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00732186
- Acronym / sponsor ID
- CA184-033
- Conditions
- Leukemia, Myeloid, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 11 Aug 2008 (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 the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 and Group 2 | Experimental | Biological: Ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ph+ CML on dasatinib therapy
- Loss of cytogenetic or molecular response while on dasatinib therapy
- On stable dose of dasatinib for a minimum of 12 weeks and with < 14 day interruption of treatment
Key exclusion criteria (3 listed)
- Blast crisis CML
- Autoimmune disease
- 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 |
|---|---|---|
| IpilimumabAlso: BMS-734016, MDX-010IV Solution, IV, 10 mg/kg, (if dose reduction necessary at 3 mg/kg), Every three weeks for the first 10 weeks, with a booster at week 22, Up to 38 weeks depending on response | Biological | Group 1 and Group 2 |
Primary outcome
To evaluate the safety of ipilimumab in combination with dasatinib in CML patients with a loss of previously achieved major molecular response or a loss of previously achieved cytogenetic response to dasatinib
Time frame: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
3 secondary outcomes
To evaluate the frequency of molecular response, complete cytogenetic response and an overall efficacy signal response rate
Time frame: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
To explore the immunologic responses to combination therapy with ipilimumab and dasatinib
Time frame: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
To explore whether molecular responses to combination therapy with ipilimumab and dasatinib correlate with immunologic responses
Time frame: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ipilimumab in people with Leukemia, Myeloid, Chronic, run by Bristol-Myers Squibb at 1 site 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 3 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the safety of ipilimumab in combination with dasatinib in CML patients with a loss of previously achieved major molecular response or a loss of previously achieved cytogenetic response to dasatinib (time frame: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38). 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.