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Tyrosine Kinase Inhibitor
Imatinib or Dasatinib for Chronic Myeloid Leukemia
Phase 2
Waitlist Available
Led By Brian J Druker
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have CML in chronic phase based on bone marrow aspiration and biopsy and peripheral blood counts obtained within 28 days before registration
Patients must have Zubrod performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.
Awards & highlights
Summary
This trial looks at two different doses of imatinib mesylate and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia.
Who is the study for?
This trial is for adults with newly diagnosed chronic phase chronic myelogenous leukemia who haven't had treatment except possibly hydroxyurea or anagrelide. They should be in good physical condition, not pregnant or breastfeeding, and willing to use birth control. Major surgery must not have been done recently, and they shouldn't have serious bleeding disorders or certain heart conditions.
What is being tested?
The study compares the effectiveness of two drugs: Imatinib Mesylate at different doses and Dasatinib. These medications are designed to block enzymes that cancer cells need to grow. The trial randomly assigns patients to receive one of these treatments.
What are the potential side effects?
Possible side effects include nausea, muscle cramps, rash, fluid retention (which can cause swelling around eyes or legs), diarrhea, fatigue, headache, joint pain; Dasatinib may also cause pleural effusion (fluid around lungs) and low blood cell counts increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My CML is in the chronic phase, confirmed by recent tests.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My heart is healthy and I've had an ECG test in the last 42 days without major issues.
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I do not have a history of serious bleeding disorders not related to my cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Molecular Response Rate at 12 Months
Secondary study objectives
2-year Overall Survival (OS)
Hematologic Response
Toxicity
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Arm III (dasatinib)Experimental Treatment2 Interventions
Patients receive dasatinib PO BID. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (BID imatinib mesylate)Experimental Treatment2 Interventions
Patients receive imatinib mesylate PO BID. Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
Group III: Arm I (QD imatinib mesylate)Experimental Treatment2 Interventions
Patients receive imatinib mesylate PO QD. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib Mesylate
2003
Completed Phase 4
~800
Dasatinib
2012
Completed Phase 3
~2320
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,010,431 Total Patients Enrolled
Brian J DrukerPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery in the last 28 days and have recovered from past surgeries.My CML is in the chronic phase, confirmed by recent tests.I can take care of myself and am up and about more than 50% of my waking hours.My heart is healthy and I've had an ECG test in the last 42 days without major issues.I was diagnosed with CML within the last 6 months and tested positive for the Philadelphia chromosome.I have CML and have only been treated with hydroxyurea or anagrelide.I haven't had chemotherapy for stem cell mobilization.I do not have a history of serious bleeding disorders not related to my cancer.I have no cancer history except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (BID imatinib mesylate)
- Group 2: Arm I (QD imatinib mesylate)
- Group 3: Arm III (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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