Clinical Trial: Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
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 Acceler
Brief Summary: The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML
Detailed Summary:
Sponsor: Bristol-Myers Squibb
Current 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Bristol-Myers Squibb
Dates:
Date Received: August 7, 2008
Date Started: August 2009
Date Completion: February 2011
Last Updated: February 16, 2016
Last Verified: November 2009
