Completed

Dasatinib for Chronic-Phase Chronic Myeloid Leukemia with Low-grade Non-Hematologic Toxicity

Study Aim

This study aims to evaluate the impact of Dasatinib treatment on resolving, improving, or worsening the mild to moderate side effects caused by Imatinib in patients with chronic-phase Chronic Myeloid Leukemia.

What is being tested

Daily Dasatinib Tablets for 12 Months

Drug

Who is being recruted

Bone Marrow Diseases+11

+ Chronic Disease

+ Hematologic Diseases

Over 18 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: December 2012

See protocol details

Summary

Principal SponsorBristol-Myers Squibb

Last updated: November 22, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

This is a treatment-focused study for individuals with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) who experience chronic, low-grade non-blood related side effects from a medication called imatinib. The goal is to understand if switching the medication from imatinib to another drug, dasatinib, can help reduce or resolve these side effects. This research is important as it aims to improve the quality of life for CP-CML patients who experience discomfort from imatinib treatment.

NCT01660906

Principal SponsorBristol-Myers Squibb

Last updated: November 22, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

39 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveDisease AttributesLeukemia, Myeloid, Chronic-Phase

Criteria

7 inclusion criteria required to participate

Adequate hepatic function

Adequate renal function

Daily Eastern Co-Operative Group (ECOG) performance status = 0 - 2

Life expectancy > 6 months

Show More Criteria

8 exclusion criteria prevent from participating

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

Current grade 3 or 4 imatinib related adverse event

Men whose partner is unwilling to avoid pregnancy

Patients who are pregnant or breast feeding

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 22 locations

Pacific Cancer Medical Center

Anaheim, United StatesOpen Pacific Cancer Medical Center in Google Maps

Cancer Center Of Central Connecticut

Southington, United States

St. Agnes Healthcare, Inc.

Baltimore, United States

Promedica Hematology & Oncology Assoicates

Sylvania, United States

Completed22 Study Centers