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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 below
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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 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

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 more

Trial 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
13,842 Previous Clinical Trials
41,002,594 Total Patients Enrolled
Brian J DrukerPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Dasatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00070499 — Phase 2
Chronic Myeloid Leukemia Research Study Groups: Arm II (BID imatinib mesylate), Arm I (QD imatinib mesylate), Arm III (dasatinib)
Chronic Myeloid Leukemia Clinical Trial 2023: Dasatinib Highlights & Side Effects. Trial Name: NCT00070499 — Phase 2
Dasatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00070499 — Phase 2
~19 spots leftby Sep 2025
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