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Imatinib Mesylate or Dasatini...

Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia

Last Updated: 2025-08-21

Study Results

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-15

Study Completion Date

2026-03-10

Brief Summary

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This randomized phase IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To compare the molecular response rates, as measured by the decrease in breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) transcripts after 12 months of treatment, in patients with previously untreated chronic myelogenous leukemia (CML) in chronic phase who are treated with either dasatinib 100 mg/day or imatinib (STI571, Gleevec) (imatinib mesylate) 400 mg/day.

II. To test whether increasing the dose of imatinib (STI571, Gleevec®) from 400 mg/day to 800 mg/day increases the rate of molecular response, as measured by the decrease in BCR-ABL transcripts after 12 months of treatment, in patients with previously untreated CML in chronic phase.

III. To estimate rates of cytogenetic and hematologic responses to imatinib 400 mg/day, imatinib 800 mg/day, and dasatinib 100 mg/day.

IV. To evaluate in a preliminary manner the prognostic effects of derivative (der)(9) and der(22) chromosomal deletions for response in CML patients treated with imatinib and dasatinib.

V. To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment.

VI. To estimate the frequency and severity of toxicities of the three treatment regimens.

VII. To evaluate, in a preliminary manner, the overall survival and relapse-free survival of patients treated with these regimens.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive imatinib mesylate orally (PO) once daily (QD). Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive imatinib mesylate PO twice daily (BID). Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive dasatinib PO BID. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 15 years.

Conditions

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Chronic Myeloid Leukemia, BCR-ABL1 Positive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (QD imatinib mesylate)

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.

Group Type EXPERIMENTAL

Imatinib Mesylate

Intervention Type DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Arm II (BID imatinib mesylate)

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 Type EXPERIMENTAL

Imatinib Mesylate

Intervention Type DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Arm III (dasatinib)

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 Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Dasatinib

Given PO

Intervention Type DRUG

Imatinib Mesylate

Given PO

Intervention Type DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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BMS 354825 BMS-354825 BMS354825 Dasatinib Hydrate Dasatinib Monohydrate Sprycel CGP 57148 CGP 57148B CGP-57148 CGP-57148B CGP57148 CGP57148B Gleevec Glivec Imarech Imat Imkeldi STI 571 STI-571 STI571

Eligibility Criteria

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Inclusion Criteria

* 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 be registered on this study within 180 days after the date of first being diagnosed with CML, based on a cytogenetic or molecular analysis of peripheral blood or bone marrow, demonstrating the presence of the Philadelphia chromosome or variants of the (9;22) translocation or testing positive for Bcr-Abl by real time-polymerase chain reaction (RT-PCR); patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome and remain eligible
* Patients must have Zubrod performance status 0-2
* Patients must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide
* Patients must not have received any prior chemotherapy regimen for peripheral blood stem cell mobilization; (prior collection of unmobilized peripheral blood stem cells is permitted)
* Serum bilirubin =\< 2.0 x the institutional upper limit of the normal (IULN)
* Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT)/alanine transaminase (ALT) =\< 2.0 x the IULN
* Patients (Southwestern Oncology Group \[SWOG\] institutions only) must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients;" collection of the pretreatment bone marrow specimen must be completed within 28 days prior to registration; the pretreatment bone marrow specimen must be submitted to an approved Southwest Oncology Group Cytogenetics Laboratory for cytogenetic analysis as described, and an aliquot of the bone marrow (or peripheral blood if the marrow aspiration is a dry tap) must be submitted for fluorescent in situ hybridization (FISH) analysis; note that protocol SWOG-9007 also requires submission of bone marrow specimens at the time of progression to the accelerated or blastic phase of CML or the loss of complete hematologic response and every six months while the patient is on this study
* Patients (SWOG institutions only) must be registered on S9910, "Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary;" specimens of peripheral blood and bone marrow must be submitted to the Southwest Oncology Group Lymphoid Leukemia and CML Centralized Laboratory in Seattle, Washington; collection of pretreatment blood and marrow specimens must be completed within 28 days prior to registration; note that this study also requires submission of peripheral blood and bone marrow specimens at various times after entry into the study
* Patients must not have undergone major surgery within 28 days before registration, and must have fully recovered from any other prior major surgery
* Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
* Patients must have an electrocardiogram (ECG) within 42 days prior to registration, and must not have any of the following cardiac symptoms prior to entry on study:

* Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within 6 months of study entry
* Diagnosed or suspected congenital long QT syndrome
* Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
* Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\> 450 msec)
* Uncontrolled hypertension
* Patients must not have a history of significant bleeding disorder unrelated to cancer, including:

* Congenital bleeding disorders (e.g., von Willebrand's disease)
* Acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian J Druker

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Kaiser Permanente-Fremont

Fremont, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status

Kaiser Permanente-Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente-Richmond

Richmond, California, United States

Site Status

Kaiser Permanente-Roseville

Roseville, California, United States

Site Status

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

Site Status

Kaiser Permanente-San Francisco

San Francisco, California, United States

Site Status

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Site Status

Kaiser Permanente San Leandro

San Leandro, California, United States

Site Status

Kaiser Permanente-San Rafael

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Site Status

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status

Kaiser Permanente-Stockton

Stockton, California, United States

Site Status

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Site Status

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Site Status

University of Colorado

Denver, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Montrose Memorial Hospital

Montrose, Colorado, United States

Site Status

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Saint Francis Hospital - Wilmington

Wilmington, Delaware, United States

Site Status

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status

Orlando Health Cancer Institute

Orlando, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

OSF Saint Anthony's Health Center

Alton, Illinois, United States

Site Status

Rush-Copley Medical Center

Aurora, Illinois, United States

Site Status

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status