Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01041703
First received: December 31, 2009
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.

PURPOSE: This randomized phase III trial is studying clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia.


Condition Intervention Phase
Leukemia
Drug: clofarabine
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: decitabine
Other: clinical observation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age >/= 60 Years)

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:
  • 30-day mortality rate [ Designated as safety issue: No ]
  • Induction complete response rates [ Designated as safety issue: No ]
  • Effect of decitabine as maintenance therapy vs observation on disease-free survival [ Designated as safety issue: No ]
  • Impact of consolidation therapy with non-myeloablative conditioning and allogeneic hematopoietic stem cell transplantation from HLA-identical sibling donor on overall survival in select patients [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 747
Study Start Date: January 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (induction therapy)
Patients receive standard therapy comprising daunorubicin hydrochloride IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.
Drug: cytarabine
Given IV
Drug: daunorubicin hydrochloride
Given IV
Experimental: Arm II (induction therapy)
Patients receive clofarabine IV over 1 hour on days 1-5.
Drug: clofarabine
Given IV
Active Comparator: Arm I (consolidation therapy)
Patients receive cytarabine IV over 1 hour once or twice daily on days 1-6. Treatment repeats every 4-6 weeks for 2 courses.
Drug: cytarabine
Given IV
Experimental: Arm II (consolidation therapy)
Patients receive clofarabine IV over 1 hour on days 1-5. Treatment repeats every 4-6 weeks for 2 courses.
Drug: clofarabine
Given IV
No Intervention: Arm I (maintenance therapy)
Patients undergo observation.
Other: clinical observation
No intervention given.
Experimental: Arm II (maintenance therapy)
Patients receive decitabine IV over 1 hour on days 1-3. Treatment repeats every 4 weeks for 12 months the absence of unacceptable toxicity.
Drug: decitabine
Given IV

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute myeloid leukemia (AML)
  • Considered candidates for intensive chemotherapy based on examination of peripheral blood or bone marrow aspirate specimens or touch preparations of the bone marrow biopsy obtained within the past 2 weeks

    • Bone marrow aspirate is required for enrollment, however, if there is discordance between percentage of myeloblasts on the differential of the peripheral blood or aspirate, the peripheral blood criteria are sufficient for diagnosis
  • Patients with secondary AML (defined as AML that has developed in a person with a history of antecedent blood count abnormalities, myelodysplastic syndromes [MDS], or a myeloproliferative disorder [excluding chronic myeloid leukemia], or a history of prior chemotherapy or radiotherapy for a disease other than AML) are eligible
  • Patients with acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or PML/RAR transcripts will be excluded
  • No blastic transformation of chronic myelogenous leukemia
  • No documented CNS involvement
  • Concurrent registration on ECOG-E3903 (Ancillary Laboratory Protocol for the Collecting of Diagnostic Samples from Patients With Leukemia or Related Hematologic Disorders Being Considered for ECOG Treatment Clinical Trials) required (except for patients participating at CTSU institutions; these patients are exempt from this requirement)

    • Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts (>10^9/L) from peripheral blood
    • Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing
  • Peripheral blood stem cell donor meeting 1 of the following criteria:

    • HLA-identical sibling (6/6)

      • Low-resolution HLA typing (A,B,DR) allowed
    • Matched unrelated donor (10/10)

      • High-resolution class I and II typing (A,B,C,DRB1 and DQ) should be matched at all 10 loci

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-3 (ECOG PS 0-2 if ≥ 70 years of age)
  • AST and ALT ≤ grade 1
  • Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ grade 1)
  • Serum creatinine ≤ 1 mg/dL (≤ grade 1)
  • Cardiac ejection fraction ≥ 45% by MUGA or 2-D ECHO
  • Fertile patients must use effective contraception
  • No concurrent active malignancy requiring treatment (other than MDS)
  • No active, uncontrolled infection
  • No known HIV infection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy for AML (except for hydroxyurea for increased blast count or leukapheresis for leukocytes)
  • No prior treatment with azacitidine, decitabine, or low-dose cytarabine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041703

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus Recruiting
New Britain, Connecticut, United States, 06050
Contact: Clinical Trials Office - George Bray Cancer Center    860-224-5660      
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center    302-645-3171      
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
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      
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Anand P. Jillella, MD    706-721-2505      
United States, Illinois
Saint Anthony's Hospital at Saint Anthony's Health Center Recruiting
Alton, Illinois, United States, 62002
Contact: Bethany G. Sleckman, MD    314-251-7057      
St. Joseph Medical Center Recruiting
Bloomington, Illinois, United States, 61701
Contact: John W. Kugler, MD    309-243-3605      
Illinois CancerCare - Bloomington Recruiting
Bloomington%, Illinois, United States, 61701
Contact: John W. Kugler, MD    309-243-3605      
Graham Hospital Recruiting
Canton, Illinois, United States, 61520
Contact: John W. Kugler, MD    309-243-3605      
Illinois CancerCare - Canton Recruiting
Canton, Illinois, United States, 61520
Contact: John W. Kugler, MD    309-243-3605      
Memorial Hospital Recruiting
Carthage, Illinois, United States, 62321
Contact: John W. Kugler, MD    309-243-3605      
Illinois CancerCare - Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: John W. Kugler, MD    309-243-3605      
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301    cancer@northwestern.edu   
Hematology and Oncology Associates Recruiting
Chicago, Illinois, United States, 60611
Contact: Clinical Trails Office - Hematology and Oncology Associates    312-695-1301      
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care    217-876-4750      
Illinois CancerCare - Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: John W. Kugler, MD    309-243-3605      
Eureka Community Hospital Recruiting
Eureka, Illinois, United States, 61530
Contact: John W. Kugler, MD    309-243-3605      
Galesburg Clinic, PC Recruiting
Galesburg, Illinois, United States, 61401
Contact: John W. Kugler, MD    309-243-3605      
Illinois CancerCare - Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: John W. Kugler, MD    309-243-3605      
Illinois CancerCare - Havana Recruiting
Havana, Illinois, United States, 62644
Contact: John W. Kugler, MD    309-243-3605      
Mason District Hospital Recruiting
Havana, Illinois, United States, 62644
Contact: John W. Kugler, MD    309-243-3605      
Kellogg Cancer Care Center Recruiting
Highland Park, Illinois, United States, 60035
Contact: Jessica K. Altman    847-480-3800      
Provena St. Mary's Regional Cancer Center - Kankakee Recruiting
Kankakee, Illinois, United States, 60901
Contact: Jessica K. Altman    815-937-8780      
Illinois CancerCare - Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: John W. Kugler, MD    309-243-3605      
North Shore Oncology and Hematology Associates, Limited - Libertyville Recruiting
Libertyville, Illinois, United States, 60048
Contact: Jessica K. Altman    847-367-6781      
McDonough District Hospital Recruiting
Macomb, Illinois, United States, 61455
Contact: John W. Kugler, MD    309-243-3605      
Illinois CancerCare - Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: John W. Kugler, MD    309-243-3605      
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center    708-226-4357      
Illinois CancerCare - Monmouth Recruiting
Monmouth, Illinois, United States, 61462
Contact: John W. Kugler, MD    309-243-3605      
OSF Holy Family Medical Center Recruiting
Monmouth, Illinois, United States, 61462
Contact: John W. Kugler, MD    309-243-3605      
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Bethany G. Sleckman, MD    314-251-7057      
Cancer Care and Hematology Specialists of Chicagoland - Niles Recruiting
Niles, Illinois, United States, 60714
Contact: Jessica K. Altman    847-827-9060      
Illinois CancerCare - Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: John W. Kugler, MD    309-243-3605      
BroMenn Regional Medical Center Recruiting
Normal, Illinois, United States, 61761
Contact: John W. Kugler, MD    309-243-3605      
Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: John W. Kugler, MD    309-243-3605      
Community Hospital of Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: John W. Kugler, MD    309-243-3605      
Oncology Hematology Associates of Central Illinois, PC - Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: John W. Kugler, MD    309-243-3605      
Illinois CancerCare - Pekin Recruiting
Pekin, Illinois, United States, 61603
Contact: John W. Kugler, MD    309-243-3605      
Cancer Treatment Center at Pekin Hospital Recruiting
Pekin, Illinois, United States, 61554
Contact: John W. Kugler, MD    309-243-3605      
OSF St. Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: John W. Kugler, MD    309-243-3605      
CCOP - Illinois Oncology Research Association Recruiting
Peoria, Illinois, United States, 61615
Contact: John W. Kugler, MD    309-243-3605      
Oncology Hematology Associates of Central Illinois, PC - Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: John W. Kugler, MD    309-243-3605      
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Clinical Trials Office - Methodist Medical Center of Illinois    309-243-3000      
Proctor Hospital Recruiting
Peoria, Illinois, United States, 61614
Contact: John W. Kugler, MD    309-243-3605      
Illinois CancerCare - Peru Recruiting
Peru, Illinois, United States, 61354
Contact: John W. Kugler, MD    309-243-3605      
Illinois Valley Community Hospital Recruiting
Peru, Illinois, United States, 61354
Contact: John W. Kugler, MD    309-243-3605      
Perry Memorial Hospital Recruiting
Princeton, Illinois, United States, 61356
Contact: John W. Kugler, MD    309-243-3605      
Illinois CancerCare - Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: John W. Kugler, MD    309-243-3605      
Swedish-American Regional Cancer Center Recruiting
Rockford, Illinois, United States, 61104-2315
Contact: Clinical Trials Office - Swedish-American Regional Cancer Cent    815-489-4413      
Hematology Oncology Associates - Skokie Recruiting
Skokie, Illinois, United States, 60076
Contact: Jessica K. Altman    847-568-9930      
Illinois CancerCare - Spring Valley Recruiting
Spring Valley, Illinois, United States, 61362
Contact: John W. Kugler, MD    309-243-3605      
Regional Cancer Center at Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me    217-788-4233      
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Howard M. Gross, MD    937-832-1093      
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Sreenivasa R. Nattam, MD    260-484-8830      
Reid Hospital & Health Care Services Recruiting
Richmond, Indiana, United States, 47374
Contact: Howard M. Gross, MD    937-832-1093      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51102
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      
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Maryland
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Frank Beardell, MD    302-737-7700      
United States, Massachusetts
Tufts Medical Center Cancer Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Kellie A. Sprague    617-636-6100      
Baystate Regional Cancer Program at D'Amour Center for Cancer Care Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Syed S. Ali    413-794-9338      
United States, Michigan
Battle Creek Health System Cancer Care Center Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Martin J. Bury    616-966-8000      
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      
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Martin J. Bury    616-391-2799      
Lacks Cancer Center at Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Martin J. Bury    616-752-5222      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center    269-373-7458      
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      
Mercy General Health Partners Recruiting
Muskegon, Michigan, United States, 49443
Contact: Martin J. Bury    231-672-2000      
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Martin J. Bury    231-935-6202      
United States, Minnesota
MeritCare Bemidji Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Preston D. Steen, MD    701-234-2397      
St. Joseph's Medical Center Recruiting
Brainerd, Minnesota, United States, 56401
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
CCOP - Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
Duluth Clinic Cancer Center - Duluth Recruiting
Duluth, Minnesota, United States, 55805-1983
Contact: Clinical Trials Office - Duluth Clinic Cancer Center - Duluth    218-786-3308      
Miller - Dwan Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, Missouri
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Bethany G. Sleckman, MD    314-251-7057      
CCOP - St. Louis-Cape Girardeau Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman, MD    314-251-7057      
Midwest Hematology Oncology Group, Incorporated Recruiting
Saint Louis, Missouri, United States, 63109
Contact: Bethany G. Sleckman, MD    314-251-7057      
David C. Pratt Cancer Center at St. John's Mercy Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J    314-251-6770      
United States, Montana
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
St. Vincent Healthcare Cancer Care Services Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin T. Marchello, MD    406-238-6290      
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. James Healthcare Cancer Care Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello, MD    406-238-6290      
Sletten Cancer Institute at Benefis Healthcare Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
Great Falls Clinic - Main Facility Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
Northern Montana Hospital Recruiting
Havre, Montana, United States, 59501
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. Peter's Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello, MD    406-238-6290      
Glacier Oncology, PLLC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Kalispell Medical Oncology at KRMC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Recruiting
Missoula, Montana, United States, 59807
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick    406-329-7029      
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM    702-384-0013      
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
United States, North Carolina
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD    252-559-2200ext.201      
United States, North Dakota
CCOP - MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD    701-234-2397      
MeritCare Broadway Recruiting
Fargo, North Dakota, United States, 58102
Contact: Preston D. Steen, MD    701-234-2397      
Roger Maris Cancer Center at MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD    701-234-2397      
United States, Ohio
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      
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: Jennifer E. Payne    330-745-1611      
Aultman Cancer Center at Aultman Hospital Recruiting
Canton, Ohio, United States, 44710-1799
Contact: Clinical Trials Office - Aultman Cancer Center at Aultman Hosp    330-363-6891      
Jewish Hospital Cancer Center Recruiting
Cincinnati, Ohio, United States, 45236
Contact: E. Randolph Broun, MD    513-686-5482      
CCOP - Dayton Recruiting
Dayton, Ohio, United States, 45420
Contact: Howard M. Gross, MD    937-832-1093      
David L. Rike Cancer Center at Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami    937-208-2079      
Good Samaritan Hospital Recruiting
Dayton, Ohio, United States, 45406
Contact: Howard M. Gross, MD    937-832-1093      
Grandview Hospital Recruiting
Dayton, Ohio, United States, 45405
Contact: Howard M. Gross, MD    937-832-1093      
Samaritan North Cancer Care Center Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard M. Gross, MD    937-832-1093      
Blanchard Valley Medical Associates Recruiting
Findlay, Ohio, United States, 45840
Contact: Howard M. Gross, MD    937-832-1093      
Middletown Regional Hospital Recruiting
Franklin, Ohio, United States, 45005-1066
Contact: Howard M. Gross, MD    937-832-1093      
Wayne Hospital Recruiting
Greenville, Ohio, United States, 45331
Contact: Howard M. Gross, MD    937-832-1093      
Charles F. Kettering Memorial Hospital Recruiting
Kettering, Ohio, United States, 45429
Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita    937-298-3399 ext. 57556      
St. Rita's Medical Center Recruiting
Lima, Ohio, United States, 45801
Contact: Clinical Trials Office - St. Rita's Medical Center    419-226-9617      
UVMC Cancer Care Center at Upper Valley Medical Center Recruiting
Troy, Ohio, United States, 45373-1300
Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall    937-440-4842      
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Recruiting
Xenia, Ohio, United States, 45385
Contact: Howard M. Gross, MD    937-832-1093      
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Shubham Pant    405-271-6822      
United States, Pennsylvania
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: Edward J. Gorak, II    570-459-2901      
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a    717-531-3779    CTO@hmc.psu.edu   
Lewistown Hospital Recruiting
Lewistown, Pennsylvania, United States, 17044
Contact: David F. Claxton    717-242-7143      
Joan Karnell Cancer Center at Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Bernard A. Mason, MD    215-829-6088      
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers    800-474-9892      
Hematology and Oncology Associates of Northeastern Pennsylvania Recruiting
Scranton, Pennsylvania, United States, 18508
Contact: Andrew E. Chapman    570-342-3675      
Geisinger Medical Group - Scenery Park Recruiting
State College, Pennsylvania, United States, 16801
Contact: Edward J. Gorak, II    814-231-4560      
Mount Nittany Medical Center Recruiting
State College, Pennsylvania, United States, 16803
Contact: David F. Claxton    814-231-7000      
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      
York Cancer Center at Apple Hill Medical Center Recruiting
York, Pennsylvania, United States, 17405
Contact: Amir Tabatabai, MD    717-741-9229      
United States, Tennessee
West Tennessee Cancer Center at Jackson-Madison County General Hospital Recruiting
Jackson, Tennessee, United States, 38301
Contact: Clinical Trials Office - West Tennessee Cancer Center    731-425-6865      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
United States, West Virginia
West Virginia University Health Sciences Center - Charleston Recruiting
Charleston, West Virginia, United States, 25304
Contact: Steven J. Jubelirer, MD    304-388-8380      
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Michael D. Craig    304-293-4500      
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo    608-262-5223      
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C    414-805-4380      
D.N. Greenwald Center Recruiting
Mukwonago, Wisconsin, United States, 53149
Contact: Michael A. Thompson    Not Available      
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      
Waukesha Memorial Hospital Regional Cancer Center Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C    262-928-7632      
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello, MD    406-238-6290      
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Jacob M. Rowe, MD    972-4-854-2541      
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Jacob M. Rowe, MD    972-4-854-2541      
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: James M. Foran, MD, FRCPC Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01041703     History of Changes
Other Study ID Numbers: CDR0000659585, ECOG-E2906
Study First Received: December 31, 2009
Last Updated: January 25, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia
secondary acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
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)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Decitabine
Clofarabine
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014