Leukemia Clinical Trial
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)
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.
Status | Recruiting |
Enrollment | 747 |
Est. completion date | |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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 |
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Medical Center | Haifa | |
Israel | Shaare Zedek Medical Center | Jerusalem | |
United States | Kapiolani Medical Center at Pali Momi | Aiea | Hawaii |
United States | Oncare Hawaii, Incorporated - Pali Momi | Aiea | Hawaii |
United States | Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio |
United States | McFarland Clinic, PC | Ames | Iowa |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | Northside Hospital Cancer Center | Atlanta | Georgia |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Saint Joseph's Hospital of Atlanta | Atlanta | Georgia |
United States | Harold Alfond Center for Cancer Care | Augusta | Maine |
United States | MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia |
United States | Aurora Presbyterian Hospital | Aurora | Colorado |
United States | WellStar Cobb Hospital | Austell | Georgia |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine |
United States | Barberton Citizens Hospital | Barberton | Ohio |
United States | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan |
United States | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana |
United States | MeritCare Bemidji | Bemidji | Minnesota |
United States | National Naval Medical Center | Bethesda | Maryland |
United States | Mecosta County Medical Center | Big Rapids | Michigan |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | UAB Comprehensive Cancer Center | Birmingham | Alabama |
United States | St. Joseph Medical Center | Bloomington | Illinois |
United States | Illinois CancerCare - Bloomington | Bloomington% | Illinois |
United States | Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | Tufts Medical Center Cancer Center | Boston | Massachusetts |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Aultman Cancer Center at Aultman Hospital | Canton | Ohio |
United States | Graham Hospital | Canton | Illinois |
United States | Illinois CancerCare - Canton | Canton | Illinois |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Illinois CancerCare - Carthage | Carthage | Illinois |
United States | Memorial Hospital | Carthage | Illinois |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia |
United States | Erlanger Cancer Center at Erlanger Hospital - Baroness | Chattanooga | Tennessee |
United States | Hematology and Oncology Associates | Chicago | Illinois |
United States | Mount Sinai Hospital Medical Center | Chicago | Illinois |
United States | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois |
United States | Jewish Hospital Cancer Center | Cincinnati | Ohio |
United States | Clackamas Radiation Oncology Center | Clackamas | Oregon |
United States | Case Comprehensive Cancer Center | Cleveland | Ohio |
United States | MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio |
United States | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado |
United States | John B. Amos Cancer Center | Columbus | Georgia |
United States | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia |
United States | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois |
United States | CCOP - Colorado Cancer Research Program | Denver | Colorado |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - St. Luke's Medical Center | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | St. Anthony Central Hospital | Denver | Colorado |
United States | St. Joseph Hospital | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota |
United States | Miller - Dwan Medical Center | Duluth | Minnesota |
United States | Union Hospital of Cecil County | Elkton MD | Maryland |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Eureka Community Hospital | Eureka | Illinois |
United States | Illinois CancerCare - Eureka | Eureka | Illinois |
United States | CCOP - MeritCare Hospital | Fargo | North Dakota |
United States | MeritCare Broadway | Fargo | North Dakota |
United States | Roger Maris Cancer Center at MeritCare Hospital | Fargo | North Dakota |
United States | Piedmont Fayette Hospital | Fayetteville | Georgia |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana |
United States | Middletown Regional Hospital | Franklin | Ohio |
United States | University of Florida Shands Cancer Center | Gainesville | Florida |
United States | Galesburg Clinic, PC | Galesburg | Illinois |
United States | Genesys Regional Medical Center | Grand Blanc | Michigan |
United States | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | Wayne Hospital | Greenville | Ohio |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Illinois CancerCare - Havana | Havana | Illinois |
United States | Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania |
United States | St. Peter's Hospital | Helena | Montana |
United States | Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Kellogg Cancer Care Center | Highland Park | Illinois |
United States | Hinsdale Hematology Oncology Associates | Hinsdale | Illinois |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Kuakini Medical Center | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Kuakini | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Lusitana | Honolulu | Hawaii |
United States | Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
United States | Castle Medical Center | Kailua | Hawaii |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology at KRMC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Provena St. Mary's Regional Cancer Center - Kankakee | Kankakee | Illinois |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois |
United States | Kinston Medical Specialists | Kinston | North Carolina |
United States | Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Gwinnett Medical Center | Lawrenceville | Georgia |
United States | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware |
United States | Lewistown Hospital | Lewistown | Pennsylvania |
United States | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky |
United States | North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville | Illinois |
United States | Kauai Medical Clinic | Lihue | Hawaii |
United States | St. Rita's Medical Center | Lima | Ohio |
United States | Littleton Adventist Hospital | Littleton | Colorado |
United States | St. Mary Mercy Hospital | Livonia | Michigan |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado |
United States | McKee Medical Center | Loveland | Colorado |
United States | Illinois CancerCare - Macomb | Macomb | Illinois |
United States | McDonough District Hospital | Macomb | Illinois |
United States | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin |
United States | Holy Family Memorial Medical Center Cancer Care Center | Manitowoc | Wisconsin |
United States | Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta | Georgia |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Winthrop University Hospital | Mineola | New York |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Illinois CancerCare - Monmouth | Monmouth | Illinois |
United States | OSF Holy Family Medical Center | Monmouth | Illinois |
United States | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
United States | D.N. Greenwald Center | Mukwonago | Wisconsin |
United States | Mercy General Health Partners | Muskegon | Michigan |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain | Connecticut |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Providence Newberg Medical Center | Newberg | Oregon |
United States | Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles | Illinois |
United States | BroMenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center | Normal | Illinois |
United States | Illinois CancerCare - Community Cancer Center | Normal | Illinois |
United States | Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin |
United States | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma |
United States | Willamette Falls Hospital | Oregon City | Oregon |
United States | Community Hospital of Ottawa | Ottawa | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois |
United States | Parker Adventist Hospital | Parker | Colorado |
United States | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois |
United States | Illinois CancerCare - Pekin | Pekin | Illinois |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois CancerCare - Peru | Peru | Illinois |
United States | Illinois Valley Community Hospital | Peru | Illinois |
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Joan Karnell Cancer Center at Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon |
United States | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Illinois CancerCare - Princeton | Princeton | Illinois |
United States | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | Southern Regional Medical Center | Riverdale | Georgia |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Swedish-American Regional Cancer Center | Rockford | Illinois |
United States | Harbin Clinic Cancer Center - Medical Oncology | Rome | Georgia |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri |
United States | David C. Pratt Cancer Center at St. John's Mercy | Saint Louis | Missouri |
United States | Midwest Hematology Oncology Group, Incorporated | Saint Louis | Missouri |
United States | Saint Louis University Cancer Center | Saint Louis | Missouri |
United States | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton | Pennsylvania |
United States | St. Nicholas Hospital | Sheboygan | Wisconsin |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
United States | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | Hematology Oncology Associates - Skokie | Skokie | Illinois |
United States | Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan |
United States | Illinois CancerCare - Spring Valley | Spring Valley | Illinois |
United States | Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield | Massachusetts |
United States | Regional Cancer Center at Memorial Medical Center | Springfield | Illinois |
United States | Geisinger Medical Group - Scenery Park | State College | Pennsylvania |
United States | Mount Nittany Medical Center | State College | Pennsylvania |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Munson Medical Center | Traverse City | Michigan |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Arizona Cancer Center at University Medical Center North | Tucson | Arizona |
United States | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona |
United States | Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver | Washington |
United States | Southwest Washington Medical Center Cancer Center | Vancouver | Washington |
United States | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin |
United States | Exempla Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
United States | York Cancer Center at Apple Hill Medical Center | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | National Cancer Institute (NCI) |
United States, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | No | ||
Secondary | 30-day mortality rate | No | ||
Secondary | Induction complete response rates | No | ||
Secondary | Effect of decitabine as maintenance therapy vs observation on disease-free survival | No | ||
Secondary | 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 | No | ||
Secondary | Quality of life | No |
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