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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Withdrawn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WITHDRAWN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
Read More
Exclusion Criteria
  • Blast crisis CML
  • Autoimmune disease
  • Uncontrolled or significant cardiovascular disease
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 1 and Group 2Ipilimumab-
Primary Outcome Measures
NameTimeMethod
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 dasatinibAt weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
Secondary Outcome Measures
NameTimeMethod
To explore whether molecular responses to combination therapy with ipilimumab and dasatinib correlate with immunologic responsesAt 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 rateAt weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
To explore the immunologic responses to combination therapy with ipilimumab and dasatinibAt 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

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