Trial record 1 of 1 for:    CALGB 10603
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Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00651261
First received: April 1, 2008
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.


Condition Intervention Phase
Leukemia
Drug: cytarabine
Drug: daunorubicin
Drug: midostaurin
Other: placebo
Drug: dexamethasone acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Duration of study (Up to 10 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OS where patients who receive a stem cell transplant are censored at the time of the transplant [ Time Frame: Duration of study (Up to 10 years) ] [ Designated as safety issue: No ]
  • Complete response rate in the remission induction stage of the study [ Time Frame: Duration of study (Up to 10 years) ] [ Designated as safety issue: No ]
  • Event- free survival [ Time Frame: Duration of study (Up to 10 years) ] [ Designated as safety issue: Yes ]
  • Disease-free survival (DFS) [ Time Frame: Duration of study (Up to 10 years) ] [ Designated as safety issue: No ]
  • DFS rate one year after completing the planned continuation phase [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Enrollment: 717
Study Start Date: April 2008
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction and consolidation chemotherapy plus midostaurin
Patients will receive a standard combination of chemotherapy drugs during remission induction therapy that includes cytarabine, daunorubicin, and the experimental drug midostaurin. Depending on the outcome of remission induction treatment, there may be a decision to discontinue the study treatment or a second remission induction cycle may be given. If remission induction therapy is successfully completed, patients will receive four courses of high-dose cytarabine consolidation chemotherapy plus dexamethasone together with the experimental drug midostaurin. All patients will undergo a bone marrow aspiration (and perhaps a biopsy) after the final course of remission consolidation chemotherapy. If the patient continues to respond to the treatment, the patient will receive continuation therapy with midostaurin for twelve (12) months.
Drug: cytarabine
Given IV
Drug: daunorubicin
Given IV
Drug: midostaurin
Given orally
Drug: dexamethasone acetate
ocular medication administration
Active Comparator: Induction and consolidation chemotherapy plus placebo
Patients will receive a standard combination of chemotherapy drugs during remission induction therapy that includes cytarabine, daunorubicin, and placebo. Depending on the outcome of remission induction treatment, there may be a decision to discontinue the study treatment or a second remission induction cycle may be given. If remission induction therapy is successfully completed, patients will receive four courses of high-dose cytarabine consolidation chemotherapy plus dexamethasone together with placebo. All patients will undergo a bone marrow aspiration (and perhaps a biopsy) after the final course of remission consolidation chemotherapy. If the patient continues to respond to the treatment, the patient will receive continuation therapy with placebo for twelve (12) months.
Drug: cytarabine
Given IV
Drug: daunorubicin
Given IV
Other: placebo
Given orally
Drug: dexamethasone acetate
ocular medication administration

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Documentation of Disease:

    • Unequivocal diagnosis of AML ( > 20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia). Patients with neurologic symptoms suggestive of CNS leukemia are recommended to have a lumbar puncture. Patients whose CSF is positive for AML blasts are not eligible.
    • Documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol- designated FLT3 screening laboratory.
  2. Age Requirement:

    • Age ≥ 18 and < 60 years
  3. Prior Therapy:

    • No prior chemotherapy for leukemia or myelodysplasia with the following exceptions:

      • emergency leukapheresis
      • emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 5 days
      • cranial RT for CNS leukostasis (one dose only)
      • growth factor/cytokine support
    • AML patients with a history of antecedent myelodysplasia (MDS) remain eligible for treatment on this trial, but must not have had prior cytotoxic therapy (e.g., azacitidine or decitabine)
    • Patients who have developed therapy related AML after prior RT or chemotherapy for another cancer or disorder are not eligible.
  4. Cardiac Function: Patients with symptomatic congestive heart failure are not eligible.
  5. Initial Laboratory Value: Total bilirubin < 2.5 x ULN (Upper Limit of Normal)
  6. Pregnancy and Nursing Status:

    • Non-pregnant and non-nursing due to the unknown teratogenic potential of midostaurin in humans, pregnant or nursing patients may not be enrolled.
    • Women of childbearing potential must have a negative serum or urine pregnancy test within a sensitivity of at least 50 mIU/mL within 16 days prior to registration.
    • Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or commit to TWO acceptable methods of birth control:

      • one highly effective method (eg, IUD, hormonal (non-oral contraceptive), tubal ligation, or partner's vasectomy) and
      • one additional effective method (e.g., latex condom, diaphragm or cervical cap)
    • The two acceptable methods of birth control must be used AT THE SAME TIME, before beginning midostaurin/placebo therapy and continuing for 12 weeks after completion of all therapy.
    • Note that oral contraceptives are not considered a high effective method because of the possibility of a drug interaction with midostaurin.
    • Women of childbearing potential is defined as a sexually active mature woman who has not undergone a hysterectomy or who has not had menses at any time in the preceding 24 consecutive months.
    • Men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking midostaurin/placebo and for 12 weeks after therapy is stopped, even if they have undergone a successful vasectomy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651261

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Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
St. Joseph Hospital
Denver, Colorado, United States, 80218
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80224-2522
Swedish Medical Center
Englewood, Colorado, United States, 80110
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Illinois
Illinois CancerCare - Bloomington
Bloomington%, Illinois, United States, 61701
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
United States, Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46845
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199
United States, Michigan
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
Munson Medical Center
Traverse City, Michigan, United States, 49684
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, United States, 11042
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States, 10940-4199
Winthrop University Hospital
Mineola, New York, United States, 11501
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States, 27834
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
St. Rita's Medical Center
Lima, Ohio, United States, 45801
United States, Oklahoma
Cleo Craig Cancer Research Clinic
Lawton, Oklahoma, United States, 73505
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Cancer Centers of the Carolinas - Easley
Easley, South Carolina, United States, 29640
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States, 29605
Greenville Hospital Cancer Center
Greenville, South Carolina, United States, 29605
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, United States, 29605
Self Regional Cancer Center at Self Regional Medical Center
Greenwood, South Carolina, United States, 29646
Cancer Centers of the Carolinas - Greer Medical Oncology
Greer, South Carolina, United States, 29650
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States, 29672
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
University of Tennessee Cancer Institute - Memphis
Memphis, Tennessee, United States, 38104
Tennessee Oncology, PLLC at Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030
Ben Taub General Hospital
Houston, Texas, United States, 77030
Veterans Affairs Medical Center - Houston
Houston, Texas, United States, 77030
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, West Virginia
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States, 25304
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States, 54221-1450
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States, 54548
D.N. Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Ministry Saint Clare's Hospital
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Novartis Pharmaceuticals
Investigators
Study Chair: Richard M. Stone, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00651261     History of Changes
Other Study ID Numbers: CALGB-10603, CALGB-10603, EUDRACT-2006-006852-37, CDR0000590404
Study First Received: April 1, 2008
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
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:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
4'-N-benzoylstaurosporine
Cytarabine
Daunorubicin
BB 1101
Staurosporine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014