Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
Phase 1
Withdrawn
- Conditions
- Leukemia, Myeloid, Chronic
- Interventions
- Biological: Ipilimumab
- Registration Number
- NCT00732186
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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
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Exclusion Criteria
- Blast crisis CML
- Autoimmune disease
- Uncontrolled or significant cardiovascular disease
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 and Group 2 Ipilimumab -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
The University Of Texas, M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States