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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
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 belowSelect...
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:Select...
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.
Select...
My chronic myeloid leukemia is not in the late, accelerated, or blast phase.
Select...
My heart condition severely limits my daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months after last dose of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after last dose of study treatment
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 moreTrial 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
13,842 Previous Clinical Trials
41,002,844 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,545 Total Patients Enrolled
Lucia MasarovaPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have recent severe chest pain, heart rhythm problems, very high blood pressure, or a history of significant bleeding disorders.I can care for myself and perform daily activities.My condition has evolved but hasn't reached an accelerated phase.I am using two effective birth control methods and have a negative pregnancy test.My chronic myeloid leukemia is not in the late, accelerated, or blast phase.I was diagnosed with early-stage CML less than a year ago and have had little to no treatment.My liver and kidney functions are within normal limits.My heart condition severely limits my daily activities.I am 16 years or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (twice daily dasatinib)
- Group 2: Arm A (once daily dasatinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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