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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00651261 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Midostaurin may help daunorubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Midostaurin also may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without midostaurin in treating acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying giving daunorubicin and cytarabine with or without midostaurin followed by high-dose cytarabine and midostaurin to see how well it works in treating patients with newly diagnosed acute myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: cytarabine Drug: daunorubicin hydrochloride Drug: midostaurin Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML) |
| Estimated Enrollment: | 514 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive remission induction comprising cytarabine IV continuously on days 1-7, daunorubicin hydrochloride IV on days 1-3, and oral midostaurin twice daily on days 8-21. Some patients may receive a second course of remission induction beginning on or after day 24. Beginning at least 4 weeks after remission induction, patients with a complete response (CR) receive consolidation therapy comprising high-dose cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5 and oral midostaurin twice daily on days 8-21. Consolidation therapy repeats every 4 weeks for up to 4 courses. Beginning at least 14 days after consolidation therapy, patients who remain in CR receive continuation therapy comprising oral midostaurin twice daily on days 1-14. Continuation therapy repeats every 28 days for up to 12 months.
|
Drug: cytarabine
Given IV
Drug: daunorubicin hydrochloride
Given IV
Drug: midostaurin
Given orally
|
|
Arm II: Active Comparator
Patients receive remission induction comprising cytarabine and daunorubicin hydrochloride as in arm I and oral placebo twice daily on days 8-21. Some patients may receive a second course of remission induction beginning on or after day 24. Beginning at least 4 weeks after remission induction, patients with a CR receive consolidation therapy comprising high-dose cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5 and oral placebo twice daily on days 8-21. Consolidation therapy repeats every 4 weeks for up to 4 courses. Beginning at least 14 days after consolidation therapy, patients who remain in CR receive continuation therapy comprising oral placebo twice daily on days 1-28. Continuation therapy repeats every 28 days for up to 12 months.
|
Drug: cytarabine
Given IV
Drug: daunorubicin hydrochloride
Given IV
Other: placebo
Given orally
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Unequivocal diagnosis of acute myeloid leukemia (AML) meeting the following criteria:
Patients with neurologic symptoms suggestive of CNS leukemia may undergo a lumbar puncture
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior therapy for leukemia or myelodysplasia, except for the following:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| UAB Comprehensive Cancer Center | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309 | |
| United States, California | |
| Stanford Cancer Center | Recruiting |
| Stanford, California, United States, 94305-5824 | |
| Contact: Clinical Trials Office - Stanford Cancer Center 650-498-7061 cctoffice@stanford.edu | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| United States, Colorado | |
| Aurora Presbyterian Hospital | Recruiting |
| Aurora, Colorado, United States, 80012 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Boulder Community Hospital | Recruiting |
| Boulder, Colorado, United States, 80301-9019 | |
| Contact: Clinical Trials Office - Boulder Community Hospital 303-938-5253 | |
| CCOP - Colorado Cancer Research Program | Recruiting |
| Denver, Colorado, United States, 80224-2522 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Exempla Lutheran Medical Center | Recruiting |
| Wheat Ridge, Colorado, United States, 80033 | |
| Contact: Clinical Trials Office - Exempla Lutheran Medical Center 303-403-3605 | |
| Hope Cancer Care Center at Longmont United Hospital | Recruiting |
| Longmont, Colorado, United States, 80501 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| McKee Medical Center | Recruiting |
| Loveland, Colorado, United States, 80539 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| St. Joseph Hospital | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| North Suburban Medical Center | Recruiting |
| Thornton, Colorado, United States, 80229 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Penrose Cancer Center at Penrose Hospital | Recruiting |
| Colorado Springs, Colorado, United States, 80933 | |
| Contact: Clinical Trials Office - Penrose Cancer Center 719-776-5275 | |
| Porter Adventist Hospital | Recruiting |
| Denver, Colorado, United States, 80210 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Presbyterian - St. Luke's Medical Center | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen 303-839-6000 | |
| Rose Medical Center | Recruiting |
| Denver, Colorado, United States, 80220 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Sky Ridge Medical Center | Recruiting |
| Lone Tree, Colorado, United States, 80124 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| St. Anthony Central Hospital | Recruiting |
| Denver, Colorado, United States, 80204 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| North Colorado Medical Center | Recruiting |
| Greeley, Colorado, United States, 80631 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Swedish Medical Center | Recruiting |
| Englewood, Colorado, United States, 80110 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | Recruiting |
| Newark, Delaware, United States, 19713 | |
| Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227 | |
| Tunnell Cancer Center at Beebe Medical Center | Recruiting |
| Lewes, Delaware, United States, 19958 | |
| Contact: Clinical Trials Office - Tunnell Cancer Center 302-645-3171 | |
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381 | |
| Walter Reed Army Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20307-5001 | |
| Contact: Clinical Trials Office - Walter Reed Army Medical Center 202-782-7840 | |
| United States, Florida | |
| Baptist Cancer Institute - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Clinical Trials Office - Baptist Cancer Institute - Jacksonvil 904-202-7051 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Recruiting |
| Orlando, Florida, United States, 32803-1273 | |
| Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623 | |
| University of Florida Shands Cancer Center | Recruiting |
| Gainesville, Florida, United States, 32610-0232 | |
| Contact: Clinical Trials Office - University of Florida Shands Cancer C 888-254-7581 | |
| United States, Georgia | |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Recruiting |
| Decatur, Georgia, United States, 30033 | |
| Contact: Thomas E. Seay, MD, PhD 404-851-2340 | |
| Medical Center of Central Georgia | Recruiting |
| Macon, Georgia, United States, 31208 | |
| Contact: Frederick M. Schnell, MD, FACP 478-743-7068 | |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Recruiting |
| Savannah, Georgia, United States, 31405 | |
| Contact: O. George Negrea, MD 912-692-2000 | |
| United States, Illinois | |
| Decatur Memorial Hospital Cancer Care Institute | Recruiting |
| Decatur, Illinois, United States, 62526 | |
| Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-6601 | |
| Mount Sinai Hospital Medical Center | Recruiting |
| Chicago, Illinois, United States, 60608 | |
| Contact: Pam G. Khosla, MD 773-542-2000 | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Clinical Trials Office - Rush University Medical Center 312-942-5498 clinical_trials@rush.edu | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| University of Illinois Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60612-7243 | |
| Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology | Recruiting |
| Fort Wayne, Indiana, United States, 46845 | |
| Contact: Sreenivasa R. Nattam, MD 260-484-8830 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Robert J. Behrens 515-244-7586 | |
| Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242-1002 | |
| Contact: Cancer Information Service 800-237-1225 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Recruiting |
| Des Moines, Iowa, United States, 50316 | |
| Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa L 515-241-8704 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa M 515-241-6727 | |
| McFarland Clinic, PC | Recruiting |
| Ames, Iowa, United States, 50010 | |
| Contact: Clinical Trials Office - McFarland Clinic, PC 515-239-2621 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Robert J. Behrens 515-282-2921 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Recruiting |
| Des Moines, Iowa, United States, 50314 | |
| Contact: Robert J. Behrens 515-643-8740 | |
| St. Luke's Regional Medical Center | Recruiting |
| Sioux City, Iowa, United States, 51104 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| Mercy Medical Center - Sioux City | Recruiting |
| Sioux City, Iowa, United States, 51104 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| Siouxland Hematology-Oncology Associates, LLP | Recruiting |
| Sioux City, Iowa, United States, 51101 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Recruiting |
| Des Moines, Iowa, United States, 50314 | |
| Contact: Robert J. Behrens 515-643-8206 | |
| United States, Kansas | |
| Cancer Center of Kansas, PA - Kingman | Recruiting |
| Kingman, Kansas, United States, 67068 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Salina | Recruiting |
| Salina, Kansas, United States, 67042 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Chanute | Recruiting |
| Chanute, Kansas, United States, 66720 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Dodge City | Recruiting |
| Dodge City, Kansas, United States, 67801 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - El Dorado | Recruiting |
| El Dorado, Kansas, United States, 67042 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Newton | Recruiting |
| Newton, Kansas, United States, 67114 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Parsons | Recruiting |
| Parsons, Kansas, United States, 67357 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Pratt | Recruiting |
| Pratt, Kansas, United States, 67124 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Wellington | Recruiting |
| Wellington, Kansas, United States, 67152 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Winfield | Recruiting |
| Winfield, Kansas, United States, 67156 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas-Independence | Recruiting |
| Independence, Kansas, United States, 67301 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Southwest Medical Center | Recruiting |
| Liberal, Kansas, United States, 67901 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Wesley Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| United States, Louisiana | |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Recruiting |
| Shreveport, Louisiana, United States, 71130-3932 | |
| Contact: Clinical Trials Office - Feist-Weiller Cancer Center at Louisi 318-813-1412 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925 | |
| Boston University Cancer Research Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Clinical Trials Office - Boston University Cancer Research Cen 617-353-7571 | |
| Caritas St. Elizabeth's Medical Center | Recruiting |
| Brighton, Massachusetts, United States, 02135-2997 | |
| Contact: Thein H. Oo 617-789-3000 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Richard M. Stone, MD 617-632-2214 | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| United States, Michigan | |
| Borgess Medical Center | Recruiting |
| Kalamazoo, Michigan, United States, 49001 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| Bronson Methodist Hospital | Recruiting |
| Kalamazoo, Michigan, United States, 49007 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| Mecosta County Medical Center | Recruiting |
| Big Rapids, Michigan, United States, 49307 | |
| Contact: Martin J. Bury 231-796-8691 | |
| CCOP - Grand Rapids | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Martin J. Bury 616-391-1230 | |
| Lacks Cancer Center at Saint Mary's Health Care | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Martin J. Bury 616-752-5222 | |
| Butterworth Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Martin J. Bury 616-391-2799 | |
| Metro Health Hospital | Recruiting |
| Wyoming, Michigan, United States, 49519 | |
| Contact: Martin J. Bury 616-252-7200 | |
| Munson Medical Center | Recruiting |
| Traverse City, Michigan, United States, 49684 | |
| Contact: Martin J. Bury 231-935-6202 | |
| West Michigan Cancer Center | Recruiting |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Contact: Clinical Trials Office - West Michigan Cancer Center 269-373-7458 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | Recruiting |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Contact: Patrick J. Flynn, MD 612-863-8585 | |
| Fairview Ridges Hospital | Recruiting |
| Burnsville, Minnesota, United States, 55337 | |
| Contact: Patrick J. Flynn, MD 612-863-8585 | |
| Minnesota Oncology Hematology, PA - Maplewood | Recruiting |
| Maplewood, Minnesota, United States, 55109 | |
| Contact: Patrick J. Flynn, MD 612-863-8585 | |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Recruiting |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Contact: Clinical Trials Office - Hubert H. Humphrey Cancer Center at N 763-520-1893 | |
| Mercy and Unity Cancer Center at Mercy Hospital | Recruiting |
| Coon Rapids, Minnesota, United States, 55433 | |
| Contact: Patrick J. Flynn, MD 612-863-8585 | |
| Mercy and Unity Cancer Center at Unity Hospital | Recruiting |
| Fridley, Minnesota, United States, 55432 | |
| Contact: Patrick J. Flynn, MD 612-863-8585 | |
| Fairview Southdale Hospital | Recruiting |
| Edina, Minnesota, United States, 55435 | |
| Contact: Clinical Trials Office - Fairview Southdale Hospital 612-625-3650 | |
| Minnesota Oncology Hematology, PA - Woodbury | Recruiting |
| Woodbury, Minnesota, United States, 55125 | |
| Contact: Patrick J. Flynn, MD 612-863-8585 | |
| Park Nicollet Cancer Center | Recruiting |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Contact: Patrick J. Flynn, MD 612-863-8585 | |
| Ridgeview Medical Center | Recruiting |
| Waconia, Minnesota, United States, 55387 | |
| Contact: Patrick J. Flynn, MD 612-863-8585 | |
| United Hospital | Recruiting |
| Saint Paul, Minnesota, United States, 55102 | |
| Contact: Patrick J. Flynn, MD 612-863-8585 | |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Contact: Clinical Trials Office - Virginia Piper Cancer Institute 612-863-5654 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Contact: Joe C. Files, MD 601-984-5615 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Recruiting |
| Columbia, Missouri, United States, 65203 | |
| Contact: Clinical Trial Office - Ellis Fischel Cancer Center 573-882-7440 | |
| Saint Louis University Cancer Center | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Clinical Trials Office - Saint Louis University Cancer Center 314-977-4440 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Geoffrey L. Uy 314-747-7222 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
| United States, New York | |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Recruiting |
| Manhasset, New York, United States, 11030 | |
| Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center 516-734-8900 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Richard I. Fisher, MD 585-275-0842 | |
| New York Weill Cornell Cancer Center at Cornell University | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| Stony Brook University Cancer Center | Recruiting |
| Stony Brook, New York, United States, 11794-9446 | |
| Contact: Clinical Trials Office - Stony Brook University Cancer Center 800-862-2215 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| Tucker Center for Cancer Care at Orange Regional Medical Center | Recruiting |
| Middletown, New York, United States, 10940-4199 | |
| Contact: Clinical Trials Office - Tucker Center for Cancer Care at Oran 845-342-7609 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
| Kinston Medical Specialists | Recruiting |
| Kinston, North Carolina, United States, 28501 | |
| Contact: Peter R. Watson, MD 252-559-2200ext.201 | |
| Leo W. Jenkins Cancer Center at ECU Medical School | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Contact: Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M 252-744-2391 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| Wayne Memorial Hospital, Incorporated | Recruiting |
| Goldsboro, North Carolina, United States, 27534 | |
| Contact: James N. Atkins, MD 919-580-0000 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
| Barberton Citizens Hospital | Recruiting |
| Barberton, Ohio, United States, 44203 | |
| Contact: Jennifer E. Payne 330-745-1611 | |
| Summa Center for Cancer Care at Akron City Hospital | Recruiting |
| Akron, Ohio, United States, 44309-2090 | |
| Contact: Clinical Trials Office - Akron City Hospital 330-375-6101 | |
| United States, Oklahoma | |
| Cancer Care Associates - Mercy Campus | Recruiting |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Contact: Howard Ozer, MD, PhD 405-271-4022 | |
| Cleo Craig Cancer Research Clinic | Recruiting |
| Lawton, Oklahoma, United States, 73505 | |
| Contact: Nadim F. Nimeh, MD 580-536-2121ext.113 | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Howard Ozer, MD, PhD 405-271-4022 | |
| United States, Pennsylvania | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Recruiting |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce 570-271-5251 | |
| Geisinger Cancer Institute at Geisinger Health | Recruiting |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Contact: Clinical Trials Office - Geisinger Cancer Institute 570-271-5251 | |
| Geisinger Hazleton Cancer Center | Recruiting |
| Hazleton, Pennsylvania, United States, 18201 | |
| Contact: Adel Z. Makary, MD 570-271-6045 | |
| Geisinger Medical Group - Scenery Park | Recruiting |
| State College, Pennsylvania, United States, 16801 | |
| Contact: Adel Z. Makary, MD 570-271-6045 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
| UPMC Cancer Centers | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224-1791 | |
| Contact: John Lister 412-578-5000 | |
| United States, South Carolina | |
| AnMed Cancer Center | Recruiting |
| Anderson, South Carolina, United States, 29621 | |
| Contact: Clinical Trials Office - AnMed Cancer Center 864-512-1000 | |
| CCOP - Upstate Carolina | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Clinical Trials Office - CCOP - Upstate Carolina 800-486-5941 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Clinical Trials Office - Gibbs Regional Cancer Center 800-486-5941 | |
| Hollings Cancer Center at Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321 | |
| United States, South Dakota | |
| Avera Cancer Institute | Recruiting |
| Sioux Falls, South Dakota, United States, 57105 | |
| Contact: Addison R. Tolentino 605-322-3000 | |
| Sanford Cancer Center at Sanford USD Medical Center | Recruiting |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| Mountainview Medical | Recruiting |
| Berlin, Vermont, United States, 05602 | |
| Contact: Contact Person 802-223-6196 | |
| United States, Virginia | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298-0037 | |
| Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
| United States, West Virginia | |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Recruiting |
| Huntington, West Virginia, United States, 25701 | |
| Contact: Oncology Research Supervisor 304-399-6617 | |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Recruiting |
| Morgantown, West Virginia, United States, 26506 | |
| Contact: Michael D. Craig 304-293-4500 | |
| West Virginia University Health Sciences Center - Charleston | Recruiting |
| Charleston, West Virginia, United States, 25304 | |
| Contact: Steven J. Jubelirer, MD 304-388-8380 | |
| United States, Wisconsin | |
| Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Recruiting |
| Eau Claire, Wisconsin, United States, 54701 | |
| Contact: Bilal H. Naqvi 715-839-3956 | |
| Marshfield Clinic - Chippewa Center | Recruiting |
| Chippewa Falls, Wisconsin, United States, 54729 | |
| Contact: Bilal H. Naqvi 715-726-4200 | |
| Marshfield Clinic - Indianhead Center | Recruiting |
| Rice Lake, Wisconsin, United States, 54868 | |
| Contact: Bilal H. Naqvi 715-236-8100 | |
| Marshfield Clinic at Saint Michael's Hospital | Recruiting |
| Stevens Point, Wisconsin, United States, 54481 | |
| Contact: Bilal H. Naqvi 715-295-1900 | |
| Marshfield Clinic - Marshfield Center | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center 800-782-1581 ext. 94457 | |
| Marshfield Clinic - Weston Center | Recruiting |
| Weston, Wisconsin, United States, 54476 | |
| Contact: Bilal H. Naqvi 715-393-1000 | |
| Marshfield Clinic - Wisconsin Rapids Center | Recruiting |
| Wisconsin Rapids, Wisconsin, United States, 54494 | |
| Contact: Bilal H. Naqvi 715-424-8600 | |
| Marshfield Clinic - Lakeland Center | Recruiting |
| Minocqua, Wisconsin, United States, 54548 | |
| Contact: Bilal H. Naqvi 715-358-1000 | |
| Marshfield Clinic Cancer Care at Regional Cancer Center | Recruiting |
| Eau Claire, Wisconsin, United States, 54701 | |
| Contact: Bilal H. Naqvi 715-387-5426 | |
| Ministry Medical Group at Saint Mary's Hospital | Recruiting |
| Rhinelander, Wisconsin, United States, 54501 | |
| Contact: Bilal H. Naqvi 715-361-4700 | |
| Regional Cancer Center at Oconomowoc Memorial Hospital | Recruiting |
| Oconomowoc, Wisconsin, United States, 53066 | |
| Contact: Clinical Trials Office - Regional Cancer Center at Oconomowoc 262-928-7878 | |
| Saint Joseph's Hospital | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Bilal H. Naqvi 715-387-1713 | |
| Saint Michael's Hospital Cancer Center | Recruiting |
| Stevens Point, Wisconsin, United States, 54481 | |
| Contact: Bilal H. Naqvi 715-346-5000 | |
| Waukesha Memorial Hospital Regional Cancer Center | Recruiting |
| Waukesha, Wisconsin, United States, 53188 | |
| Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C 262-928-7632 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 1V8 | |
| Contact: Contact Person 902-473-6000 | |
| Canada, Ontario | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Joseph Brandwein, MD 416-946-2824 | |
| Canada, Quebec | |
| Maisonneuve-Rosemont Hospital | Recruiting |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Contact: Julie Bergeron 514-252-3400 | |
| Principal Investigator: | Richard M. Stone, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Cancer and Leukemia Group B ( Richard L. Schilsky ) |
| Study ID Numbers: | CDR0000590404, CALGB-10603, EUDRACT-2006-006852-37 |
| Study First Received: | April 1, 2008 |
| Last Updated: | November 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00651261 History of Changes |
| Health Authority: | Unspecified |
|
adult acute basophilic leukemia adult acute eosinophilic leukemia adult acute lymphoblastic leukemia adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) |
adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myelomonocytic leukemia (M4) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) untreated adult acute myeloid leukemia |
|
Antimetabolites Anti-Infective Agents Daunorubicin Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Leukemia, Myeloid |
Antibiotics, Antineoplastic Leukemia, Myeloid, Acute 4'-N-benzoylstaurosporine Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Leukemia Neoplasms Therapeutic Uses Cytarabine |