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Withdrawn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

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:
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Texas | |
The University Of Texas, M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
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 |