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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid, Chronic

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-033

NCT ID:

NCT00732186

Start Date:

August 2009

Completion Date:

February 2011

Related Keywords:

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

Name

Location

The University of Texas, M.D. Anderson Cancer CenterHouston, Texas  77030