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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

No Placebo-Only Group

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 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.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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