Acute Myeloid Leukemia Clinical Trial
Official title:
A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (7+3) Therapy or Idarubicin With High Dose Cytarabine (IA) Versus IA With Vorinostat (NSC-701852) (IA + V) in Younger Patients With Previously Untreated Acute Myeloid Leukemia (AML)
Verified date | November 2018 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or idarubicin and cytarabine with or without vorinostat to see how well they work in treating younger patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells. It is not yet known which combination chemotherapy is more effective in treating acute myeloid leukemia.
Status | Completed |
Enrollment | 754 |
Est. completion date | June 15, 2017 |
Est. primary completion date | June 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - STEP 1 - INDUCTION/RE-INDUCTION - Patients must have morphologically confirmed newly diagnosed acute myelogenous leukemia (AML) with blood or bone marrow disease; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible; note: this protocol uses World Health Organization (WHO) diagnostic criteria for AML; patients with acute promyelocytic leukemia (APL, French-American-British [FAB], M3) or blastic transformation of chronic myelogenous leukemia (CML) are not eligible; patients with known core binding factor (CBF) or fms-like tyrosine kinase 3 (FLT3) related leukemias are eligible for this study, but should preferentially be placed on National Cancer Institute (NCI)-sponsored protocols specific for these subtypes, if available - Patients must have diagnostic/pre-treatment specimens obtained within 28 days prior to registration submitted for cytogenetic (and fluorescent in situ hybridization [FISH] if possible) analysis to determine risk status; high risk classification will be defined as del(5q)/-5, del(7q)/-7, abn3q26 [inv(3)/t(3;3)], 11q23 rearrangement [except t(9;11)], 17p-, t(6;9), t(9;22), complex (at least 3 unrelated abnormalities [abn]), and monosomal karyotype (either loss of two different chromosomes or loss of one chromosome along with a structural chromosome abnormality other than add, ring and mar); karyograms and cytogenetics/FISH analysis reports must be submitted for discipline review - Patients must be chemo-naïve, i.e., not have received any prior induction chemotherapy for AML or myelodysplastic syndrome (MDS); temporary prior measures such as apheresis or hydroxyurea are allowed; prior anthracycline therapy is allowed, but must not exceed a dose of 200 mg/m^2 daunorubicin or equivalent; prior all-trans retinoic acid (ATRA) for suspected APL is allowed; prior methotrexate for central nervous system (CNS) involvement is allowed; patients with prior history of MDS must not have received azacitidine, decitabine, lenalidomide or vorinostat - Patients must have peripheral blood and bone marrow aspirate specimens obtained within 28 days prior to registration submitted for translational medicine; with patient consent, residuals will be banked for future research - Patients must have Zubrod performance status =< 3 - Patients must have either echocardiogram (ECHO) or multi gated acquisition scan (MUGA) with ejection fraction >= 45% within 28 days prior to registration - Patients must not have prolonged corrected QT (QTc) interval (> 500 msec) determined by electrocardiogram (EKG) within 28 days prior to registration - Patients must not have cardiac disease defined as: New York Heart Association (NYHA) > class II; patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months - Patients must not have any coexisting medical condition that is likely to interfere with study procedures or results, and must be reasonable candidates for intensive chemotherapy, in the opinion of their treating physicians - Patients who are known to be human immunodeficiency virus (HIV) positive (+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration: - Cluster of differentiation (CD) 4 cells >= 500/mm^3 - Viral load < 50 copies of HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or < 25,000 copies of HIV mRNA if not on cART - No zidovudine or stavudine as part of cART; patients who are HIV+ and do not meet all of these criteria are not eligible for this study - Patients with known hepatitis B or hepatitis C infection may be eligible providing they have viral load < 800,000 IU/mL within 28 days prior to registration - Patients must be able to take oral medications - Patients must have a history and physical examination obtained within 28 days prior to registration - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures - Prior malignancy is allowed providing it does not require concurrent therapy; exception: active hormonal therapy is allowed - Patients must not be receiving valproic acid - All patients must be informed of the investigational nature of this study; patients or a legally authorized representative must sign and give written informed consent in accordance with institutional and federal guidelines - As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - STEP 2 - CONSOLIDATION - Patients may be registered for consolidation provided that they were eligible for the initial induction/re-induction registration and satisfy the following additional criteria: - Patients must have achieved morphologic remission (complete remission [CR] or complete remission with incomplete blood count recover [CRi]) after completion of induction or re-induction therapy; patient must remain in remission until beginning consolidation and this must be documented by bone marrow and peripheral blood examination within 28 days prior to registration to Step 2 - All non-hematologic treatment related toxicities that are deemed clinically significant by the treating physician must have resolved to =< grade 2 - Patients must not have received allogeneic stem cell transplant |
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | QEII Health Sciences Centre/Nova Scotia Health Authority | Halifax | Nova Scotia |
Canada | The Moncton Hospital | Moncton | New Brunswick |
Canada | CIUSSSEMTL-Hopital Maisonneuve-Rosemont | Montreal | Quebec |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Atlantic Health Sciences Corporation-Saint John Regional Hospital | Saint John | New Brunswick |
United States | Providence Regional Cancer System-Aberdeen | Aberdeen | Washington |
United States | Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | American Fork Hospital / Huntsman Intermountain Cancer Center | American Fork | Utah |
United States | McFarland Clinic PC-William R Bliss Cancer Center | Ames | Iowa |
United States | Cancer Care Center at Island Hospital | Anacortes | Washington |
United States | Alaska Breast Care and Surgery LLC | Anchorage | Alaska |
United States | Alaska Oncology and Hematology LLC | Anchorage | Alaska |
United States | Alaska Regional Hospital | Anchorage | Alaska |
United States | Alaska Women's Cancer Care | Anchorage | Alaska |
United States | Anchorage Oncology Centre | Anchorage | Alaska |
United States | Anchorage Radiation Therapy Center | Anchorage | Alaska |
United States | Katmai Oncology Group | Anchorage | Alaska |
United States | Providence Alaska Medical Center | Anchorage | Alaska |
United States | AnMed Health Cancer Center | Anderson | South Carolina |
United States | Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Asheville Hematology-Oncology Associates | Asheville | North Carolina |
United States | Cancer Care of Western North Carolina | Asheville | North Carolina |
United States | Hope Women's Cancer Centers-Asheville | Asheville | North Carolina |
United States | Mission Hospital-Memorial Campus | Asheville | North Carolina |
United States | Mountain Radiation Oncology | Asheville | North Carolina |
United States | Northside Hospital | Atlanta | Georgia |
United States | Harold Alfond Center for Cancer Care | Augusta | Maine |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Summa Barberton Hospital | Barberton | Ohio |
United States | Flaget Memorial Hospital | Bardstown | Kentucky |
United States | Baton Rouge General Medical Center | Baton Rouge | Louisiana |
United States | Hematology/Oncology Clinic LLP | Baton Rouge | Louisiana |
United States | Bronson Battle Creek | Battle Creek | Michigan |
United States | Swedish Cancer Institute-Eastside Oncology Hematology | Bellevue | Washington |
United States | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington |
United States | Saint Charles Health System | Bend | Oregon |
United States | Central Vermont Medical Center/National Life Cancer Treatment | Berlin | Vermont |
United States | Spectrum Health Big Rapids Hospital | Big Rapids | Michigan |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Montana Cancer Consortium NCORP | Billings | Montana |
United States | Saint Vincent Frontier Cancer Center | Billings | Montana |
United States | Saint Vincent Healthcare | Billings | Montana |
United States | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Joseph Medical Center | Bloomington | Illinois |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Saint Luke's Mountain States Tumor Institute | Boise | Idaho |
United States | Central Care Cancer Center-Carrie J Babb Cancer Center | Bolivar | Missouri |
United States | Parkland Health Center-Bonne Terre | Bonne Terre | Missouri |
United States | McFarland Clinic PC-Boone | Boone | Iowa |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | CoxHealth Cancer Center | Branson | Missouri |
United States | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington |
United States | Harrison Medical Center | Bremerton | Washington |
United States | Transylvania Regional Hospital | Brevard | North Carolina |
United States | Lafayette Family Cancer Center-EMMC | Brewer | Maine |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California |
United States | Highline Medical Center-Main Campus | Burien | Washington |
United States | University of Vermont College of Medicine | Burlington | Vermont |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana |
United States | Illinois CancerCare-Canton | Canton | Illinois |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Memorial Hospital of Carbondale | Carbondale | Illinois |
United States | Illinois CancerCare-Carthage | Carthage | Illinois |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | Sandra L Maxwell Cancer Center | Cedar City | Utah |
United States | Miami Valley Hospital South | Centerville | Ohio |
United States | Centralia Oncology Clinic | Centralia | Illinois |
United States | Providence Regional Cancer System-Centralia | Centralia | Washington |
United States | Cancer Center of Kansas - Chanute | Chanute | Kansas |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Memorial Hospital | Chattanooga | Tennessee |
United States | Mount Sinai Hospital Medical Center | Chicago | Illinois |
United States | Northwestern University | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | Bethesda North Hospital | Cincinnati | Ohio |
United States | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc - Anderson | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Blue Ash | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Eden Park | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Kenwood | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Mercy West | Cincinnati | Ohio |
United States | The Jewish Hospital | Cincinnati | Ohio |
United States | TriHealth Cancer Institute-Anderson | Cincinnati | Ohio |
United States | TriHealth Cancer Institute-Westside | Cincinnati | Ohio |
United States | Clackamas Radiation Oncology Center | Clackamas | Oregon |
United States | Providence Oncology and Hematology Care Southeast | Clackamas | Oregon |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa |
United States | Mercy Cancer Center-West Lakes | Clive | Iowa |
United States | Big Horn Basin Cancer Center | Cody | Wyoming |
United States | Billings Clinic-Cody | Cody | Wyoming |
United States | Kootenai Medical Center | Coeur d'Alene | Idaho |
United States | University of Missouri - Ellis Fischel | Columbia | Missouri |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Bay Area Hospital | Coos Bay | Oregon |
United States | Commonwealth Cancer Center-Corbin | Corbin | Kentucky |
United States | Alegent Health Mercy Hospital | Council Bluffs | Iowa |
United States | Oncology Hematology Care Inc-Crestview | Crestview Hills | Kentucky |
United States | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri |
United States | Northside Hospital-Forsyth | Cumming | Georgia |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Dayton NCI Community Oncology Research Program | Dayton | Ohio |
United States | Good Samaritan Hospital - Dayton | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Samaritan North Health Center | Dayton | Ohio |
United States | Beaumont Hospital-Dearborn | Dearborn | Michigan |
United States | Cancer Care Center of Decatur | Decatur | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa |
United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Cancer Center of Kansas - Dodge City | Dodge City | Kansas |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin |
United States | Sacred Heart Hospital | Eau Claire | Wisconsin |
United States | Fairview-Southdale Hospital | Edina | Minnesota |
United States | Swedish Medical Center-Edmonds | Edmonds | Washington |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Cancer Center of Kansas - El Dorado | El Dorado | Kansas |
United States | Saint Elizabeth Hospital | Enumclaw | Washington |
United States | Ephrata Cancer Center | Ephrata | Pennsylvania |
United States | Ephrata Community Hospital | Ephrata | Pennsylvania |
United States | Green Bay Oncology - Escanaba | Escanaba | Michigan |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois |
United States | Providence Regional Cancer Partnership | Everett | Washington |
United States | Oncology Hematology Care Inc-Healthplex | Fairfield | Ohio |
United States | Weisberg Cancer Treatment Center | Farmington Hills | Michigan |
United States | Saint Francis Hospital | Federal Way | Washington |
United States | Blanchard Valley Hospital | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Fort Wayne Medical Oncology and Hematology Inc-Parkview | Fort Wayne | Indiana |
United States | Angel Medical Center | Franklin | North Carolina |
United States | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | Vanderbilt-Ingram Cancer Center Cool Springs | Franklin | Tennessee |
United States | Unity Hospital | Fridley | Minnesota |
United States | Saint Luke's Mountain States Tumor Institute - Fruitland | Fruitland | Idaho |
United States | University of Florida Health Science Center - Gainesville | Gainesville | Florida |
United States | Illinois CancerCare-Galesburg | Galesburg | Illinois |
United States | Western Illinois Cancer Treatment Center | Galesburg | Illinois |
United States | Adams Cancer Center | Gettysburg | Pennsylvania |
United States | NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois |
United States | CHI Health Saint Francis | Grand Island | Nebraska |
United States | Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan |
United States | Mercy Health Saint Mary's | Grand Rapids | Michigan |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Great Falls Clinic | Great Falls | Montana |
United States | Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin |
United States | Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin |
United States | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin |
United States | Saint Francis Hospital | Greenville | South Carolina |
United States | Wayne Hospital | Greenville | Ohio |
United States | Gibbs Cancer Center-Pelham | Greer | South Carolina |
United States | Cherry Tree Cancer Center | Hanover | Pennsylvania |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | Park Ridge Hospital Breast Health Center | Hendersonville | North Carolina |
United States | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania |
United States | Hematology Oncology Associates of Illinois-Highland Park | Highland Park | Illinois |
United States | NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois |
United States | Pulmonary Medicine Center of Chattanooga-Hixson | Hixson | Tennessee |
United States | Mercy Cancer Center-Hot Springs | Hot Springs | Arkansas |
United States | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas |
United States | Ben Taub General Hospital | Houston | Texas |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Michael E DeBakey VA Medical Center | Houston | Texas |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Centerpoint Medical Center LLC | Independence | Missouri |
United States | Franciscan Health Indianapolis | Indianapolis | Indiana |
United States | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | IU Health Central Indiana Cancer Centers-East | Indianapolis | Indiana |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan |
United States | Swedish Cancer Institute-Issaquah | Issaquah | Washington |
United States | Allegiance Health | Jackson | Michigan |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | McFarland Clinic PC-Jefferson | Jefferson | Iowa |
United States | Capital Region Medical Center-Goldschmidt Cancer Center | Jefferson City | Missouri |
United States | UW Cancer Center Johnson Creek | Johnson Creek | Wisconsin |
United States | Freeman Health System | Joplin | Missouri |
United States | Mercy Hospital-Joplin | Joplin | Missouri |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Presence Saint Mary's Hospital | Kankakee | Illinois |
United States | Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri |
United States | Research Medical Center | Kansas City | Missouri |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | University of Kansas Cancer Center | Kansas City | Kansas |
United States | CHI Health Good Samaritan | Kearney | Nebraska |
United States | Heartland Hematology and Oncology | Kearney | Nebraska |
United States | Kadlec Clinic Hematology and Oncology | Kennewick | Washington |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Cancer Center of Kansas-Kingman | Kingman | Kansas |
United States | Kinston Medical Specialists PA | Kinston | North Carolina |
United States | Seattle Cancer Care Alliance at EvergreenHealth | Kirkland | Washington |
United States | Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | UC San Diego Moores Cancer Center | La Jolla | California |
United States | Providence Regional Cancer System-Lacey | Lacey | Washington |
United States | Saint Clare Hospital | Lakewood | Washington |
United States | Carolina Blood and Cancer Care Associates PA-Lancaster | Lancaster | South Carolina |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri |
United States | Lewistown Hospital | Lewistown | Pennsylvania |
United States | Saint Joseph Hospital East | Lexington | Kentucky |
United States | Saint Joseph Radiation Oncology Resource Center | Lexington | Kentucky |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | Cancer Center of Kansas-Liberal | Liberal | Kansas |
United States | Liberty Radiation Oncology Center | Liberty | Missouri |
United States | NorthShore Hematology Oncology-Libertyville | Libertyville | Illinois |
United States | Saint Elizabeth Regional Medical Center | Lincoln | Nebraska |
United States | Saint Mary Mercy Hospital | Livonia | Michigan |
United States | Logan Regional Hospital | Logan | Utah |
United States | PeaceHealth Saint John Medical Center | Longview | Washington |
United States | Jewish Hospital | Louisville | Kentucky |
United States | Jewish Hospital Medical Center Northeast | Louisville | Kentucky |
United States | Saints Mary and Elizabeth Hospital | Louisville | Kentucky |
United States | Illinois CancerCare-Macomb | Macomb | Illinois |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | North Shore University Hospital | Manhasset | New York |
United States | Cancer Center of Kansas-Manhattan | Manhattan | Kansas |
United States | Holy Family Memorial Hospital | Manitowoc | Wisconsin |
United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
United States | Bay Area Medical Center | Marinette | Wisconsin |
United States | McDowell Hospital | Marion | North Carolina |
United States | West Jefferson Medical Center | Marrero | Louisiana |
United States | McFarland Clinic PC-Marshalltown | Marshalltown | Iowa |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Marshfield Medical Center | Marshfield | Wisconsin |
United States | Fremont - Rideout Cancer Center | Marysville | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Cancer Center of Kansas - McPherson | McPherson | Kansas |
United States | Saint Luke's Mountain States Tumor Institute - Meridian | Meridian | Idaho |
United States | Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Health Partners Inc | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Community Medical Hospital | Missoula | Montana |
United States | Montana Cancer Specialists | Missoula | Montana |
United States | Saint Patrick Hospital - Community Hospital | Missoula | Montana |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
United States | Skagit Valley Hospital | Mount Vernon | Washington |
United States | ProHealth D N Greenwald Center | Mukwonago | Wisconsin |
United States | Intermountain Medical Center | Murray | Utah |
United States | Mercy Health Mercy Campus | Muskegon | Michigan |
United States | Saint Luke's Mountain States Tumor Institute - Nampa | Nampa | Idaho |
United States | Vanderbilt Breast Center at One Hundred Oaks | Nashville | Tennessee |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | Yale University | New Haven | Connecticut |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | Northwell Health/Center for Advanced Medicine | New Hyde Park | New York |
United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
United States | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | New Ulm Medical Center | New Ulm | Minnesota |
United States | Mount Sinai Hospital | New York | New York |
United States | Providence Newberg Medical Center | Newberg | Oregon |
United States | Cancer Center of Kansas - Newton | Newton | Kansas |
United States | Illinois Cancer Specialists-Niles | Niles | Illinois |
United States | Assarian Cancer Center | Novi | Michigan |
United States | ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin |
United States | Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin |
United States | McKay-Dee Hospital Center | Ogden | Utah |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska |
United States | Alegent Health Immanuel Medical Center | Omaha | Nebraska |
United States | Alegent Health Lakeside Hospital | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Hemotology and Oncology Consultants PC | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Memorial GYN Plus | Ooltewah | Tennessee |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | Providence Willamette Falls Medical Center | Oregon City | Oregon |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Radiation Oncology of Northern Illinois | Ottawa | Illinois |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Saint Luke's South Hospital | Overland Park | Kansas |
United States | Stanford Cancer Institute Palo Alto | Palo Alto | California |
United States | Midlands Community Hospital | Papillion | Nebraska |
United States | Cancer Center of Kansas - Parsons | Parsons | Kansas |
United States | Saint Joseph's Regional Medical Center | Paterson | New Jersey |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Valley Radiation Oncology | Peru | Illinois |
United States | Drexel University School of Medicine | Philadelphia | Pennsylvania |
United States | University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Lake Huron Medical Center | Port Huron | Michigan |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | Providence Saint Vincent Medical Center | Portland | Oregon |
United States | Kootenai Cancer Center | Post Falls | Idaho |
United States | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington |
United States | Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas |
United States | Cancer Center of Kansas - Pratt | Pratt | Kansas |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Utah Valley Regional Medical Center | Provo | Utah |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
United States | Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin |
United States | Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin |
United States | Reid Health | Richmond | Indiana |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | Carolina Blood and Cancer Care Associates PA | Rock Hill | South Carolina |
United States | SwedishAmerican Regional Cancer Center/ACT | Rockford | Illinois |
United States | Delbert Day Cancer Institute at PCRMC | Rolla | Missouri |
United States | Saint John's Clinic-Rolla-Cancer and Hematology | Rolla | Missouri |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Saint Mary's of Michigan | Saginaw | Michigan |
United States | Dixie Medical Center Regional Cancer Center | Saint George | Utah |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota |
United States | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri |
United States | Cancer Center of Kansas - Salina | Salina | Kansas |
United States | LDS Hospital | Salt Lake City | Utah |
United States | Utah Cancer Specialists-Salt Lake City | Salt Lake City | Utah |
United States | Kootenai Cancer Clinic | Sandpoint | Idaho |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Kaiser Permanente Washington | Seattle | Washington |
United States | Minor and James Medical PLLC | Seattle | Washington |
United States | Pacific Gynecology Specialists | Seattle | Washington |
United States | Swedish Medical Center-Ballard Campus | Seattle | Washington |
United States | Swedish Medical Center-First Hill | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
United States | United General Hospital | Sedro-Woolley | Washington |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | HSHS Saint Nicholas Hospital | Sheboygan | Wisconsin |
United States | Providence Regional Cancer System-Shelton | Shelton | Washington |
United States | Jewish Hospital Medical Center South | Shepherdsville | Kentucky |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Mercy Medical Center-Sioux City | Sioux City | Iowa |
United States | Saint Luke's Regional Medical Center | Sioux City | Iowa |
United States | Siouxland Regional Cancer Center | Sioux City | Iowa |
United States | Hematology Oncology Associates of Illinois - Skokie | Skokie | Illinois |
United States | North Shore Medical Center | Skokie | Illinois |
United States | Providence Hospital-Southfield Cancer Center | Southfield | Michigan |
United States | Spartanburg Medical Center | Spartanburg | South Carolina |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | Evergreen Hematology and Oncology PS | Spokane | Washington |
United States | Rockwood Cancer Treatment Center-DHEC-Downtown | Spokane | Washington |
United States | Rockwood Clinic | Spokane | Washington |
United States | Rockwood Clinic Cancer Treatment Center-Valley | Spokane Valley | Washington |
United States | Central Illinois Hematology Oncology Center | Springfield | Illinois |
United States | CoxHealth South Hospital | Springfield | Missouri |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Mercy Hospital Springfield | Springfield | Missouri |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Springfield Clinic | Springfield | Illinois |
United States | Springfield Regional Cancer Center | Springfield | Ohio |
United States | Springfield Regional Medical Center | Springfield | Ohio |
United States | Blue Ridge Regional Hospital | Spruce Pine | North Carolina |
United States | Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | Missouri Baptist Sullivan Hospital | Sullivan | Missouri |
United States | Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri |
United States | Cancer Care Specialists of Illinois-Swansea | Swansea | Illinois |
United States | Franciscan Research Center-Northwest Medical Plaza | Tacoma | Washington |
United States | Northwest Medical Specialties PLLC | Tacoma | Washington |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | The University of Arizona Medical Center-University Campus | Tucson | Arizona |
United States | University of Arizona Cancer Center-North Campus | Tucson | Arizona |
United States | University of Arizona Cancer Center-Orange Grove Campus | Tucson | Arizona |
United States | Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma |
United States | Warren Clinic Oncology-Tulsa | Tulsa | Oklahoma |
United States | Saint Luke's Mountain States Tumor Institute-Twin Falls | Twin Falls | Idaho |
United States | MGC Hematology Oncology-Union | Union | South Carolina |
United States | Compass Oncology Vancouver | Vancouver | Washington |
United States | PeaceHealth Southwest Medical Center | Vancouver | Washington |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Providence Saint Mary Regional Cancer Center | Walla Walla | Washington |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | ProHealth Waukesha Memorial Hospital | Waukesha | Wisconsin |
United States | UW Cancer Center at ProHealth Care | Waukesha | Wisconsin |
United States | Marshfield Clinic-Wausau Center | Wausau | Wisconsin |
United States | Cancer Center of Kansas - Wellington | Wellington | Kansas |
United States | Wenatchee Valley Hospital and Clinics | Wenatchee | Washington |
United States | Mercy Medical Center-West Lakes | West Des Moines | Iowa |
United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
United States | Saint Clare's Hospital | Weston | Wisconsin |
United States | Associates In Womens Health | Wichita | Kansas |
United States | Cancer Center of Kansas - Wichita | Wichita | Kansas |
United States | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas |
United States | Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Wichita NCI Community Oncology Research Program | Wichita | Kansas |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | Cancer Center of Kansas - Winfield | Winfield | Kansas |
United States | Southeast Clinical Oncology Research (SCOR) Consortium NCORP | Winston-Salem | North Carolina |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Wright-Patterson Medical Center | Wright-Patterson Air Force Base | Ohio |
United States | Greene Memorial Hospital | Xenia | Ohio |
United States | North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington |
United States | Providence Regional Cancer System-Yelm | Yelm | Washington |
United States | WellSpan Health-York Cancer Center | York | Pennsylvania |
United States | WellSpan Health-York Hospital | York | Pennsylvania |
United States | Yuma Cancer Center | Yuma | Arizona |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prevalence of the Mutation NPM1 in Patients on This Study. | To estimate the prevalence of the mutation NPM1 in this patient population. | Baseline | |
Other | Prevalence of the Mutations IDH1, IDH2, TET2, DMT3A in Patients on This Study | To estimate the prevalence of these mutations in this patient population. This objective will be analyzed as funding allows. |
Baseline | |
Other | Cytogenetic Risk Distribution of Patients on This Study | To estimate the cytogenetic risk distribution of patients on this study. | Baseline | |
Other | Overall Survival (OS) | To compare OS between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. OS is calculated for all patients from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. 2-year OS by arm will be estimated using the Kaplan-Meier method. |
OS assessed for up to 5 years, 2 year OS reported | |
Other | Complete Response (CR) Rate | To compare the complete response rate between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. Complete response is defined as: ANC >= 1,000/mcl, platelet count >= 100,000/mcl, < 5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease (no requirements for marrow cellularity or hemoglobin concentration) |
Up to 5 years | |
Other | Disease-free Survival (DFS) | To compare the disease-free survival (DFS) between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery) . DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. 2-year DFS by arm will be estimated using the Kaplan-Meier method. |
DFS assessed for up to 5 years, 2 year DFS reported | |
Primary | Event-free Survival (EFS) | EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. 2-year EFS by arm will be estimated using the Kaplan-Meier method. EFS will be compared between Arm I and Arm III and between Arm II and Arm III using Cox proportional hazards regression. |
EFS assessed for up to 5 years, 2 year EFS reported | |
Primary | Rate of Allogeneic HCT | The goal of the transplant objective is to determine whether it is possible to conduct allogeneic HCT on 60% or more of adults with high-risk AML in first complete remission (alternative). If 40% or fewer of high-risk patients in CR can be transplanted, the proposed transplant support system will not be considered feasible. A one-sided binomial test compared to the null transplant rate will be conducted. | Up to 5 years | |
Secondary | Disease-free Survival (DFS) Among High Risk Patients | DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery). DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. 2-year DFS for high risk patients will be estimated using the Kaplan-Meier method. |
DFS assessed for up to 5 years, 2 year DFS reported | |
Secondary | EFS of Arm I Compared to Arm II | EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. A two-sided test of the hazard ratio (HR) of 7:3: IA (versus the null hypothesis of HR =1) will be done using a proportional hazards regression model with the stratification factors included as covariates. 2-year EFS by arm will be estimated using the Kaplan-Meier method. |
EFS assessed for up to 5 years, 2 year EFS reported | |
Secondary | Frequency and Severity of Toxicities | Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event. | Up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
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