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Phase II Randomized Study of Imatinib Mesylate at Standard Versus Increased Dose or Dasatinib in Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Imatinib Mesylate or Dasatinib in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Active
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18 and over
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NCI
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SWOG-S0325
S0325, ECOG-S0325, NCT00070499
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Special Category:
NCI Web site featured trial Objectives - Compare the rate of molecular response, as measured by the decrease in bcr-abl transcripts after 12 months of treatment, in patients with previously untreated chronic phase chronic myelogenous leukemia treated with imatinib mesylate at standard vs increased dose or dasatinib.
- Test whether increasing doese of imatinib mesylate from 400 mg/day to 800 mg/day increases molecular response rate (as measured by decrese in bcr-abl transcript after 12 months of treatment) in these patients.
- Compare rates of cytogenetic and hematologic response in patients treated with these regimens.
- Compare, preliminarily, the prognostic effects of der(9) and der(22) chromosomal deletions for response in patients treated with these regimens.
- Compare, preliminarily, changes in gene expression at pre-treatment vs at relapse or progression in patients treated with these regimens.
- Compare the frequency and severity of the toxic effects of these regimens in these patients.
- Compare, preliminarily, the overall survival and relapse-free survival of patients treated with these regimens.
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
Biologic therapy - No other concurrent anticancer biologic agents
Chemotherapy - No prior chemotherapy for peripheral blood stem cell mobilization
- Prior collection of unmobilized peripheral blood stem cells allowed
- No other concurrent anticancer chemotherapy
- Concurrent hydroxyurea and/or anagrelide to control blood counts allowed provided it is only administered during the first 28 days of study therapy and for no more than 28 additional days after study therapy
Endocrine therapy Radiotherapy - No concurrent anticancer radiotherapy
Surgery - More than 28 days since prior major surgery and recovered
Other Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - No significant bleeding disorder unrelated to cancer including:
- Congenital bleeding disorders (e.g., von Willebrand's disease)
- Acquired bleeding disorder within the past year (e.g., acquired anti-factor VIII antibodies)
Hepatic - Bilirubin no greater than 2.0 times upper limit of normal (ULN)
- AST or ALT no greater than 2.0 times ULN
Renal Cardiovascular - No cardiac symptoms including any of the following:
- Uncontrolled angina
- Congestive heart failure or myocardial infarction within the past 6 months
- Diagnosed or suspected congenital long QT syndrome
- History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- Prolonged QTc interval on electrocardiogram (> 450 msec)
- Uncontrolled hypertension
Other - Not pregnant or nursing
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
Expected Enrollment 400A total of 335 patients will be accrued for this study. Outcomes Primary Outcome(s)Molecular response at 12 months
Hematological response
Cytogenetic response (complete and partial response) measured on bone marrow at baseline, 6 and 12 months
Prognostic effects
Changes in gene expression at pre-treatment and relapse
Frequency and severity of toxic effects
Overall and relapse-free survival
Outline This is a randomized, multicenter study. Patients are stratified according to Hasford risk category (low vs intermediate vs high). Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive oral imatinib mesylate once daily.
- Arm II: Patients receive oral imatinib mesylate twice daily.
- Arm III: Patients receive oral dasatinib twice daily.
In all arms, treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Patients are followed for up to 5 years.
Trial Contact Information
Trial Lead Organizations Southwest Oncology Group | | | | Brian Druker, MD, Study coordinator | | | Ph: 503-494-5596; 800-494-1234 |
| | | Marilyn Slovak, PhD, Study coordinator | | | Ph: 626-256-4673 ext. 62438; 800-826-4673 |
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Eastern Cooperative Oncology Group | | | | Peter Emanuel, MD, Study coordinator | | | |
Trial Sites
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| U.S.A. |
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| California |
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Burbank |
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| | | | | | | | | Providence Saint Joseph Medical Center - Burbank |
| | | Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank | |
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Los Angeles |
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| | | USC/Norris Comprehensive Cancer Center and Hospital |
| | | Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital | |
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| Delaware |
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Lewes |
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| | | | Tunnell Cancer Center at Beebe Medical Center |
| | | Clinical Trials Office - Tunnell Cancer Center | |
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Newark |
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| | | CCOP - Christiana Care Health Services |
| | | Clinical Trial Office - CCOP - Christiana Care Health Services | |
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| Florida |
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Jacksonville |
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| | | | Mayo Clinic - Jacksonville |
| | | Clinical Trials Office - All Mayo Clinic Locations | |
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Miami |
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| | | University of Miami Sylvester Comprehensive Cancer Center - Miami |
| | | University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service | |
| | Email:
Sylvester@emergingmed.com |
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Orlando |
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| | | M.D. Anderson Cancer Center at Orlando |
| | | Julio Hajdenberg, MD | |
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Tampa |
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| | | H. Lee Moffitt Cancer Center and Research Institute at University of South Florida |
| | | Clinical Trials Office - H. Lee Moffitt Cancer Center and Reseach Institute | |
| | Email:
canceranswers@moffitt.org |
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| Illinois |
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Alton |
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| | | | Saint Anthony's Hospital at Saint Anthony's Health Center |
| | | Bethany Sleckman, MD | |
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Aurora |
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| | | Rush-Copley Cancer Care Center |
| | | Kendrith Rowland, MD | |
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Bloomington |
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| | | St. Joseph Medical Center |
| | | John Kugler, MD | |
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Canton |
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| | | Graham Hospital |
| | | John Kugler, MD | |
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Carthage |
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| | | Memorial Hospital |
| | | John Kugler, MD | |
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Chicago |
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| | | Hematology and Oncology Associates |
| | | Clinical Trails Office - Hematology and Oncology Associates | |
| | | Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
| | | Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| | Email:
cancer@northwestern.edu |
| | | University of Chicago Cancer Research Center |
| | | Clinical Trials Office - University of Chicago Cancer Research Center | |
| | | University of Illinois Cancer Center |
| | | Clinical Trial Office - University of Illinois Cancer Center | |
| | | Veterans Affairs Medical Center - Chicago Westside Hospital |
| | | Martin Tallman, MD | |
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Decatur |
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| | | Decatur Memorial Hospital Cancer Care Institute |
| | | Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute | |
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Eureka |
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| | | Eureka Community Hospital |
| | | John Kugler, MD | |
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Galesburg |
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| | | Galesburg Clinic, PC |
| | | John Kugler, MD | |
| | | Galesburg Cottage Hospital |
| | | John Kugler, MD | |
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Havana |
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| | | Mason District Hospital |
| | | John Kugler, MD | |
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Hopedale |
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| | | Hopedale Medical Complex |
| | | John Kugler, MD | |
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Joliet |
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| | | Joliet Oncology-Hematology Associates, Limited - West |
| | | Kendrith Rowland, MD | |
| | | Midwest Center for Hematology/Oncology |
| | | Martin Tallman, MD | |
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Libertyville |
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| | | North Shore Oncology and Hematology Associates, Limited - Libertyville |
| | | Martin Tallman, MD | |
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Macomb |
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| | | McDonough District Hospital |
| | | John Kugler, MD | |
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Maywood |
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| | | Cardinal Bernardin Cancer Center at Loyola University Medical Center |
| | | Clinical Trials Office - Cardinal Bernardin Cancer Center | |
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Mt. Vernon |
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| | | Good Samaritan Regional Health Center |
| | | Bethany Sleckman, MD | |
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Naperville |
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| | | La Grange Oncology Associates - Geneva |
| | | Martin Tallman, MD | |
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Niles |
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| | | Cancer Care and Hematology Specialists of Chicagoland - Niles |
| | | Martin Tallman, MD | |
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Normal |
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| | | BroMenn Regional Medical Center |
| | | John Kugler, MD | |
| | | Community Cancer Center |
| | | John Kugler, MD | |
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Ottawa |
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| | | Community Hospital of Ottawa |
| | | John Kugler, MD | |
| | | Oncology Hematology Associates of Central Illinois, PC - Ottawa |
| | | John Kugler, MD | |
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Pekin |
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| | | Cancer Treatment Center at Pekin Hospital |
| | | John Kugler, MD | |
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Peoria |
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| | | CCOP - Illinois Oncology Research Association |
| | | John Kugler, MD | |
| | | Methodist Medical Center of Illinois |
| | | Clinical Trials Office - Methodist Medical Center of Illinois | |
| | | Oncology Hematology Associates of Central Illinois, PC - Peoria |
| | | John Kugler, MD | |
| | | OSF St. Francis Medical Center |
| | | John Kugler, MD | |
| | | Proctor Hospital |
| | | John Kugler, MD | |
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Peru |
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| | | Illinois Valley Community Hospital |
| | | John Kugler, MD | |
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Princeton |
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| | | Perry Memorial Hospital |
| | | John Kugler, MD | |
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Rockford |
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| | | Swedish-American Regional Cancer Center |
| | | Clinical Trials Office - Swedish-American Regional Cancer Center | |
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Skokie |
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| | | Hematology Oncology Associates - Skokie |
| | | Martin Tallman, MD | |
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Spring Valley |
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| | | St. Margaret's Hospital |
| | | John Kugler, MD | |
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Springfield |
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| | | Regional Cancer Center at Memorial Medical Center |
| | | Clinical Trials Office - Regional Cancer Center at Memorial Medical Center | |
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Urbana |
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| | | Carle Cancer Center at Carle Foundation Hospital |
| | | Clinical Trials Office - Carle Cancer Center | |
| | | CCOP - Carle Cancer Center |
| | | Clinical Trials Office - CCOP - Carle Cancer Center | |
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| Indiana |
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Fort Wayne |
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| | | | Fort Wayne Medical Oncology and Hematology |
| | | Sreenivasa Nattam, MD | |
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Michigan City |
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| | | Saint Anthony Memorial Health Centers |
| | | Kendrith Rowland, MD | |
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| Iowa |
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Ames |
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| | | | McFarland Clinic, PC |
| | | Clinical Trials Office - McFarland Clinic, PC | |
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| Kansas |
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Chanute |
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| | | | Cancer Center of Kansas, PA - Chanute |
| | | Shaker Dakhil, MD, FACP | |
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Dodge City |
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| | | Cancer Center of Kansas, PA - Dodge City |
| | | Shaker Dakhil, MD, FACP | |
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El Dorado |
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| | | Cancer Center of Kansas, PA - El Dorado |
| | | Shaker Dakhil, MD, FACP | |
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Independence |
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| | | Cancer Center of Kansas-Independence |
| | | Shaker Dakhil, MD, FACP | |
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Kingman |
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| | | Cancer Center of Kansas, PA - Kingman |
| | | Shaker Dakhil, MD, FACP | |
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Lawrence |
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| | | Lawrence Memorial Hospital |
| | | Rakesh Gaur, MD | |
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Liberal |
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| | | Southwest Medical Center |
| | | Shaker Dakhil, MD, FACP | |
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Newton |
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| | | Cancer Center of Kansas, PA - Newton |
| | | Shaker Dakhil, MD, FACP | |
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Overland Park |
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| | | Johnson County Radiation Therapy |
| | | Rakesh Gaur, MD | |
| | | Menorah Medical Center |
| | | Rakesh Gaur, MD | |
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Parsons |
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| | | Cancer Center of Kansas, PA - Parsons |
| | | Shaker Dakhil, MD, FACP | |
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Pratt |
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| | | Cancer Center of Kansas, PA - Pratt |
| | | Shaker Dakhil, MD, FACP | |
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Salina |
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| | | Cancer Center of Kansas, PA - Salina |
| | | Shaker Dakhil, MD, FACP | |
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Shawnee Mission |
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| | | Shawnee Mission Medical Center |
| | | Rakesh Gaur, MD | |
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Topeka |
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| | | Cotton-O'Neil Cancer Center |
| | | Clinical Trials Office - Cotton-O'Neil Cancer Center | |
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Wellington |
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| | | Cancer Center of Kansas, PA - Wellington |
| | | Shaker Dakhil, MD, FACP | |
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Wichita |
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| | | Associates in Womens Health, PA - North Review |
| | | Shaker Dakhil, MD, FACP | |
| | | Cancer Center of Kansas, PA - Wichita |
| | | Shaker Dakhil, MD, FACP | |
| | | Cancer Center of Kansas, PA - Medical Arts Tower |
| | | Shaker Dakhil, MD, FACP | |
| | | CCOP - Wichita |
| | | Shaker Dakhil, MD, FACP | |
| | | Via Christi Cancer Center at Via Christi Regional Medical Center |
| | | Shaker Dakhil, MD, FACP | |
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Winfield |
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| | | Cancer Center of Kansas, PA - Winfield |
| | | Shaker Dakhil, MD, FACP | |
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| Maine |
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Bangor |
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| | | | CancerCare of Maine at Eastern Maine Medical Center |
| | | Clinical Trials Office - CancerCare of Maine | |
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York |
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| | | York Hospital's Oncology Treatment Center |
| | | Jonathan Eneman | |
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| Maryland |
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Elkton MD |
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| | | | Union Hospital Cancer Program at Union Hospital |
| | | Stephen Grubbs, MD | |
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| Massachusetts |
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Boston |
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| | | | Dana-Farber/Brigham and Women's Cancer Center |
| | | Clinical Trials Office | |
| | | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
| | | Martha Wadleigh | | Ph: | 617-632-3474 | | 866-790-4500 |
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| | | Massachusetts General Hospital |
| | | Clinical Trials Office - Massachusetts General Hospital | |
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| Michigan |
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Ann Arbor |
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