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Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: April 1, 2008   Last Updated: November 21, 2009   History of Changes
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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response rate in the remission induction stage of the study [ Designated as safety issue: No ]
  • Event- free survival [ Designated as safety issue: Yes ]
  • Disease-free survival (DFS) [ Designated as safety issue: No ]
  • DFS rate one year after completing the planned continuation phase [ Designated as safety issue: No ]

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
Criteria

DISEASE CHARACTERISTICS:

  • Unequivocal diagnosis of acute myeloid leukemia (AML) meeting the following criteria:

    • More than 20% blasts present in the bone marrow, as defined by WHO classification
    • Documented FLT3 mutation (i.e., internal tandem duplication [ITD] or point mutation), determined by analysis in a protocol-designated FLT3 screening laboratory
  • No acute promyelocytic leukemia (M3)
  • Patients with antecedent myelodysplasia (MDS) allowed, provided they received no prior cytotoxic (including azacytidine or decitabine) therapy for MDS
  • No therapy-related AML after prior radiotherapy or chemotherapy for another disorder or cancer
  • Patients with neurologic symptoms suggestive of CNS leukemia may undergo a lumbar puncture

    • Patients with a positive CSF for AML blasts are not eligible

PATIENT CHARACTERISTICS:

  • No symptomatic congestive heart failure
  • Bilirubin < 2.5 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective contraception during and for 12 weeks after completion of study therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior therapy for leukemia or myelodysplasia, except for the following:

    • Emergency leukapheresis
    • Emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 5 days
    • Cranial radiotherapy for CNS leukostasis (one dose only)
    • Growth factor or cytokine support
  • No concurrent hormones or other chemotherapy, except steroids given for hypersensitivity or transfusion reactions or hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • No concurrent apprepitant
  • No concurrent enrollment on another clinical trial with investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651261

  Hide Study Locations
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        
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: Richard M. Stone, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009