Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2008
CompletedFirst Posted
Study publicly available on registry
August 11, 2008
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFebruary 17, 2016
November 1, 2009
1.5 years
August 7, 2008
February 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
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
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
At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
Study Arms (1)
Group 1 and Group 2
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Blast crisis CML
- Autoimmune disease
- Uncontrolled or significant cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University Of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 7, 2008
First Posted
August 11, 2008
Study Start
August 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
February 17, 2016
Record last verified: 2009-11