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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00732186

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Aug 1, 2009

Anticipated Primary Completion Date :

Feb 1, 2011

Anticipated Study Completion Date :

Feb 1, 2011

Arms and Interventions

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

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

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 [At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38]

Secondary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00732186

Other Study ID Numbers:

CA184-033

First Posted:

Aug 11, 2008

Last Update Posted:

Feb 17, 2016

Last Verified:

Nov 1, 2009

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Ipilimumab

Study Results

No Results Posted as of Feb 17, 2016