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



Status:Active, not recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:August 15, 2004

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A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase

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.

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.

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
We found this trial at
331
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1575 Beam Ave
Maplewood, Minnesota 55109
(651) 232-7000
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
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Alton, Illinois 62002
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Ames, Iowa 50010
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Anderson, South Carolina 29621
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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1500 East Medical Center Drive
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Ann Arbor, Michigan 48106
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Arkansas City, Kansas 67005
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2000 Ogden Ave
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489 State St
Bangor, Maine 04401
(207) 973-7000
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Baton Rouge, Louisiana 70806
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265 Fremont St
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Beech Grove, Indiana 46107
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205 Palmer Ave.
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1233 North 30th Street
Billings, Montana 59101
406-237-7000
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Bloomington, Illinois 61701
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
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450 Brookline Ave
Boston, Massachusetts 2215
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Bozeman, Montana 59715
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
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400 South Clark Street
Butte, Montana 59701
406-723-2500
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Canton, Illinois 61520
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2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
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Cape Girardeau, Missouri 63701
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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1454 North County Road 2050
Carthage, Illinois 62321
(217) 357-8500
Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, Illinois 60616
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Chicago, Illinois 60625
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676 N St Clair St #2140
Chicago, Illinois 60611
(312) 664-5400
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1200 West Harrison Stree
Chicago, Illinois 60607
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
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Columbia, Missouri 65201
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Columbus, Ohio 43222
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5100 W Broad St
Columbus, Ohio 43228
(614) 544-1000
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3535 Olentangy River Rd
Columbus, Ohio 43214
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111 S Grant Ave
Columbus, Ohio 43215
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Cooperstown, New York 13326
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
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Dayton, Ohio 45428
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405 W Grand Ave
Dayton, Ohio 45405
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2222 Philadelphia Dr
Dayton, Ohio 45406
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Dayton, Ohio 45415
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Dearborn, Michigan 48124
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Decatur, Illinois 62526
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
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561 W. Central Avenue
Delaware, Ohio 43015
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Denver, Colorado 80210
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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Detroit, Michigan 48236
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2020 Central Ave
Dodge City, Kansas 67801
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900 W. Clairemont Ave.
Eau Claire, Wisconsin 54701
715 839-3956
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900 West Clairemont Avenue
Eau Claire, Wisconsin 54701
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
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700 West Central
El Dorado, Kansas 67042
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Elkton, Maryland 21921
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Eureka, Illinois 61530
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1900 S Main St
Findlay, Ohio 45840
(419) 423-4500
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420 S Saginaw St
Flint, Michigan 48502
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555 East Cheves Street
Florence, South Carolina 29506
843-777-2000
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