Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib

NCT ID: NCT00320190

Last Updated: 2013-10-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2010-01-31

Brief Summary

The purpose of this study is to compare the efficacy of dasatinib with that of high-dose (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The safety of these treatments will also be evaluated.

Detailed Description

Participants were randomized 2:1 to dasatinib or high-dose imatinib, respectively. Randomization was stratified by a suboptimal response, defined as a hematologic response less than a complete hematologic response after at least 3 months of monotherapy with 400-mg imatinib; a cytogenic response (CgR) less than a partial CgR (PCgR) after at least 6 months of monotherapy with 400-mg; a PCgR after at least 12 months of monotherapy with 400-mg imatinib; or less than a major molecular response with a complete CgR after at least 18 months of monotherapy with 400-mg imatinib.

Participants received either dasatinib or imatinib for 12 months or until disease progression, unacceptable toxicity, consent withdrawal, or study discontinuation. After 12 months, who had a confirmed major molecular response and were still receiving dasatinib, 100 mg, or imatinib, 800 mg, were eligible to extend treatment for an additional 12 months. Participants permanently discontinuing treatment before 12 months were considered treatment failures and withdrawn from the study.

Conditions

Leukemia, Myeloid, Chronic

Keywords

Chronic phase CML, with a suboptimal response after treatment with imatinib

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dasatinib

Participants with chronic phase chronic myeloid leukemia (CML) who had only a suboptimal response after at least 3 months of therapy with imatinib, 400 mg.

Group Type: ACTIVE_COMPARATOR

Dasatinib

Intervention Type: DRUG

Dasatinib tablets administered orally at a dose of 100 mg once daily.

Imatinib

Participants with chronic phase CML who had only a suboptimal response after at least 3 months of therapy with imatinib, 400 mg.

Group Type: ACTIVE_COMPARATOR

Imatinib

Intervention Type: DRUG

Imatinib tablets administered orally at a dose of 400 mg twice daily. Each 400- mg dose to be taken with a meal and a large glass of water.

Interventions

Imatinib

Imatinib tablets administered orally at a dose of 400 mg twice daily. Each 400- mg dose to be taken with a meal and a large glass of water.

Intervention Type: DRUG

Dasatinib

Dasatinib tablets administered orally at a dose of 100 mg once daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chronic phase Ph^+ chronic myeloid leukemia (CML) demonstrating only a suboptimal response, defined as a hematologic response that is less than a complete hematologic response after at least 3 months of monotherapy with imatinib, 400 mg; a cytogenic response (CgR) that is less than a partial CgR (PCgR) after at least 6 months of monotherapy with imatinib, 400 mg; a PCgR after at least 12 months of monotherapy with imatinib, 400 mg; or less than a major molecular response with a complete CgR after at least 18 months of monotherapy with imatinib, 400 mg.
• Either gender
• Age of 18 years or older

Exclusion Criteria

• Previous diagnosis of accelerated phase or blast crisis CML
• Uncontrolled or significant cardiovascular disease
• History of significant bleeding disorder unrelated to CML
• Concurrent malignancies
• Intolerance of imatinib, 400 mg
• Prior treatment with imatinib at a dose higher than 400 mg
• Prior stem cell transplantation and/or high-dose chemotherapy for CML

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Antwerp, , Belgium

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Charleroi, , Belgium

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Helsinki, , Finland

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Tampere, , Finland

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Paris, , France

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Rennes, , France

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Strasbourg, , France

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Toulouse, , France

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Leipzig, , Germany

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Orbassano (To), , Italy

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Oslo, , Norway

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Trondheim, , Norway

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Lisbon, , Portugal

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Murcia, , Spain

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Lund, , Sweden

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Örebro, , Sweden

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Uppsala, , Sweden

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Glasgow, Central, United Kingdom

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London, Greater London, United Kingdom

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London, Greater London, United Kingdom

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Leeds, North Yorkshire, United Kingdom

Countries

Argentina; Denmark; Netherlands; Poland; South Africa; Switzerland; Turkey (Türkiye); Belgium; Finland; France; Germany; Italy; Norway; Portugal; Russia; Spain; Sweden; United Kingdom

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

EUDRACT Number: 2005-005153-22

Identifier Type: -

Identifier Source: secondary_id

CA180-043

Identifier Type: -

Identifier Source: org_study_id