Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-10-31

Brief Summary

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This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.

Detailed Description

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Conditions

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Chronic Phase Chronic Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dasatinib (100 mg)

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

tablets, oral, 100 mg, Once daily, Up to12 months on study,

Interventions

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Dasatinib

tablets, oral, 100 mg, Once daily, Up to12 months on study,

Intervention Type DRUG

Other Intervention Names

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Sprycel

Eligibility Criteria

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Inclusion Criteria

* Patients with CML-CP patients achieving an optimal response to imatinib treatment with Grade 1 or 2 non-hematologic adverse events persisting for at least 2 months or recurring at least 3 times in the preceding 12 months, despite best supportive care
* Men and women with Chronic Myeloid Leukemia- Chronic Phase (CML-CP) Ph+ ≥ age 18
* Daily Eastern Co-Operative Group (ECOG) performance status = 0 - 2
* Patient willing and able to give informed consent
* Life expectancy \> 6 months
* Adequate renal function
* Adequate hepatic function

Exclusion Criteria

* Patients who are pregnant or breast feeding
* Men whose partner is unwilling to avoid pregnancy.
* Previous treatment with any other tyrosine-kinase inhibitor (TKI), except for imatinib
* Current grade 3 or 4 imatinib related adverse event
* Prior documented T315I mutation
* Prior diagnosis of accelerated phase or blast crisis CML
* Previous loss of complete hematologic response (CHR) or major cytogenetic response (MCyR) on imatinib
* Concurrent medical condition of uncontrolled infection, cardiovascular diseases of cardiac failure, congenital long QT syndrome, ventricular arrhythmias, prolonged QT interval, second or third degree heart block, uncontrolled angina, myocardial infarction (MI) in the last 6 months, uncontrolled hypertension, pulmonary arterial hypertension, pleural or pericardial effusions, or history of bleeding disorder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

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2011-006180-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA180-400

Identifier Type: -

Identifier Source: org_study_id

Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Dasatinib (100 mg)

Dasatinib

Interventions

Dasatinib

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Bristol-Myers Squibb

Responsible Party

Principal Investigators

Bristol-Myers Squibb

Locations

Pacific Cancer Medical Center

Cancer Center Of Central Connecticut

St. Agnes Healthcare, Inc.

Promedica Hematology & Oncology Assoicates

The University Of Texas Md Anderson Cancer Center

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Related Links

Other Identifiers

2011-006180-21

CA180-400