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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00732186
First received: August 7, 2008
Last updated: January 24, 2011
Last verified: November 2009
  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:


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:
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
Leukemia, Myeloid, Accelerated Phase
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 21, 2014