Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia - Full Text View

Purpose

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

Condition	Intervention	Phase
Leukemia, Myeloid, Chronic	Biological: Ipilimumab	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Chronic Myeloid Leukemia Leukemia

Drug Information available for: Ipilimumab

Genetic and Rare Diseases Information Center resources: Chronic Myeloid Leukemia Chronic Myeloproliferative Disorders Leukemia, Myeloid

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	30
Study Start Date:	August 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

No publications provided


Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00732186 History of Changes
Other Study ID Numbers:	CA184-033
Study First Received:	August 7, 2008
Last Updated:	January 24, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases	Hematologic Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 27, 2015