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

Bristol-Myers Squibb1 site in 1 countryAugust 2009

ConditionsLeukemia, Myeloid, Chronic

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Leukemia, Myeloid, Chronic
Sponsor: Bristol-Myers Squibb
Locations: 1
Primary Endpoint: 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
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

February 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

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

Outcomes

Primary Outcomes

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 Outcomes

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)