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
18 Years
N/A
Both
Leukemia, Myeloid, Chronic
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Outcome Time Frame:
At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA184-033
NCT ID:
NCT00732186
Start Date:
August 2009
Completion Date:
February 2011
Related Keywords:
- Leukemia, Myeloid, Chronic
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Accelerated Phase
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Name | Location |
|---|---|
| The University of Texas, M.D. Anderson Cancer Center | Houston, Texas 77030 |
