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

Leukemia, Myeloid, Chronic Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00732186
• Other study ID #: CA184-033
• Status: Withdrawn
• Phase: Phase 1
• First received: August 7, 2008
• Last updated: February 16, 2016
• Start date: August 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	The University Of Texas, M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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