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Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00732186
Recruitment Status : Withdrawn
First Posted : August 11, 2008
Last Update Posted : February 17, 2016
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Chronic Biological: Ipilimumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2009
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1 and Group 2 Biological: Ipilimumab
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
Other Names:
  • BMS-734016
  • MDX-010


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732186


Locations
United States, Texas
The University Of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00732186     History of Changes
Other Study ID Numbers: CA184-033
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: November 2009

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Accelerated Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
 Antibodies, Monoclonal
Dasatinib
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action