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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00732186

Enrollment

Registered

2008-08-11

Start date

2009-08-31

Completion date

2011-02-28

Last updated

2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myeloid, Chronic

Brief summary

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

Interventions

BIOLOGICALIpilimumab

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026