Back to resultsStudy of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
Primary Purpose
Leukemia, Myeloid, Chronic
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ipilimumab
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Chronic
Eligibility Criteria
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
Exclusion Criteria:
- Blast crisis CML
- Autoimmune disease
- Uncontrolled or significant cardiovascular disease
Sites / Locations
- The University Of Texas, M.D. Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group 1 and Group 2
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
To evaluate the frequency of molecular response, complete cytogenetic response and an overall efficacy signal response rate
To explore the immunologic responses to combination therapy with ipilimumab and dasatinib
To explore whether molecular responses to combination therapy with ipilimumab and dasatinib correlate with immunologic responses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00732186
Brief Title
Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Withdrawn
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
February 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 and Group 2
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, MDX-010
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
Blast crisis CML
Autoimmune disease
Uncontrolled or significant cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
The University Of Texas, M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
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