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Tyrosine Kinase Inhibitor

Dasatinib for Chronic Myeloid Leukemia

Phase 2
Waitlist Available
Led By Lucia Masarova
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance of 0-2
Adequate end organ function: total bilirubin <1.5 x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN
Must not have
Cardiac Symptoms: Uncontrolled angina within 3 months, congenital long QT syndrome, clinically significant ventricular arrhythmias, prolonged QTc interval, uncontrolled hypertension, history of significant bleeding disorder
Women of pregnancy potential must practice 2 effective methods of birth control, avoid pregnancy during trial participation, and have a negative pregnancy test prior to receiving investigational product
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after last dose of study treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial studies dasatinib for early chronic phase chronic myelogenous leukemia. Dasatinib may stop cancer cell growth by blocking enzymes needed for cell growth.

Who is the study for?
This trial is for patients aged 16 or older with early chronic phase Chronic Myelogenous Leukemia (CML), diagnosed within the last 12 months, who have had minimal prior treatment. They should be in good physical condition (ECOG performance of 0-2) and have normal organ function. Pregnant or breastfeeding women are excluded, as well as those with serious heart disease, uncontrolled psychiatric disorders, significant bleeding disorders, or a history of arrhythmias.
What is being tested?
The study is testing Dasatinib's effectiveness in treating early chronic phase CML by blocking enzymes that cancer cells need to grow. It includes quality-of-life assessments and laboratory biomarker analysis to understand how well it works and its impact on patients' lives.
What are the potential side effects?
While not specified here, common side effects of Dasatinib may include fluid retention issues like swelling around the eyes or in the lungs, low blood cell counts which can increase infection risk or cause fatigue/bleeding problems, nausea, diarrhea, muscle pain and skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself and perform daily activities.
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My liver and kidney functions are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have recent severe chest pain, heart rhythm problems, very high blood pressure, or a history of significant bleeding disorders.
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I am using two effective birth control methods and have a negative pregnancy test.
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My chronic myeloid leukemia is not in the late, accelerated, or blast phase.
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My heart condition severely limits my daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after last dose of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after last dose of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Quality of life during dasatinib therapy
Symptom burden during dasatinib therapy (optional)
Symptom severity during dasatinib therapy
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (twice daily dasatinib)Experimental Treatment5 Interventions
Patients receive dasatinib PO BID for up to 15-18 years.
Group II: Arm A (once daily dasatinib)Experimental Treatment5 Interventions
Patients receive dasatinib PO QD for up to 15-18 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
2012
Completed Phase 3
~2320

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,961 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,191 Total Patients Enrolled
Lucia MasarovaPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
Lucia Masarova, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

Dasatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00254423 — Phase 2
Chronic Myelogenous Leukemia Research Study Groups: Arm B (twice daily dasatinib), Arm A (once daily dasatinib)
Chronic Myelogenous Leukemia Clinical Trial 2023: Dasatinib Highlights & Side Effects. Trial Name: NCT00254423 — Phase 2
Dasatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00254423 — Phase 2
~8 spots leftby Dec 2025
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