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

NCT ID: NCT00732186

Last Updated: 2016-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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Conditions

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Leukemia, Myeloid, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 and Group 2

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-734016 MDX-010

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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The University Of Texas, M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA184-033

Identifier Type: -

Identifier Source: org_study_id

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