Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial
Official title:
Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin &Amp; 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)
Verified date | June 2023 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase III trial studies 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. 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.
Status | Active, not recruiting |
Enrollment | 727 |
Est. completion date | October 2024 |
Est. primary completion date | February 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria for Step 1 (Induction): - Sexually active males must be strongly advised to use an accepted and effective method of contraception - Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin =< grade 1 - Newly-diagnosed AML patients according to World Health Organization (WHO) classification who are considered candidates for intensive chemotherapy based upon examination of peripheral blood or bone marrow aspirate specimens or touch preparations of the bone marrow biopsy obtained within two weeks prior to randomization; a bone marrow aspirate is required for enrollment; however, on occasion there is discordance between percentage of myeloblasts on the differential of the peripheral blood or aspirate; the peripheral blood criteria are sufficient for diagnosis; confirmatory immunophenotyping will be performed centrally - ECOG performance status (PS) 0-3 (restricted to ECOG PS 0-2 if >= 70 years of age) - Patients with secondary AML are eligible for enrollment onto the trial; secondary AML is defined as AML that has developed in a person with a history of antecedent blood count abnormalities, or myelodysplastic syndrome (MDS), or a myeloproliferative disorder (excluding chronic myeloid leukemia); or a history of prior chemotherapy or radiation therapy for a disease other than AML - Total serum bilirubin =< 1.5 times upper limit of normal (ULN) (=< grade 1); if total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible - Patients with a serum creatinine > 1 are eligible if they have a calculated glomerular filtration rate (GFR) of >= 60 ml/min (i.e. class I or class II chronic kidney disease ) using the Modification of Diet in Renal Disease (MDRD) formula - Note: Daily creatinine and MDRD formula are only for the 1st induction cycle - Cardiac ejection fraction >= 45% or within institutional normal limits; a nuclear medicine gated blood pool examination is preferred; a two-dimensional (2-D) echocardiogram (ECHO) scan is acceptable if a calculated ejection fraction is obtained and follow-up measurement of the cardiac ejection fraction will also be performed by echocardiography; measurement of cardiac ejection fraction should be within two weeks prior to receiving treatment - NOTE: when a multi gated acquisition scan (MUGA) or echocardiogram cannot be obtained due to weekend or holiday, then patients may be enrolled provided there is no history of significant cardiovascular disease and a measurement of cardiac ejection fraction will be performed within 5 days of study enrollment - Patients with suspected central nervous system (CNS) involvement should undergo lumbar puncture - Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts (>10^9/l) from peripheral blood - HLA typing should be performed at registration, if possible - Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing Exclusion Criteria for Step 1 (Induction): - Concurrent active malignancy for which they are receiving treatment (other than myelodysplastic syndromes [MDS]) - Active, uncontrolled infection - Acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or promyelocytic leukemia (PML)/retinoic acid receptor (RAR) alpha transcripts - Blastic transformation of chronic myelogenous leukemia - Prior therapy of MDS with decitabine, low-dose cytarabine, or azacitidine - Prior chemotherapy for AML with the exception of hydroxyurea for increased blast count or leukapheresis for leukocytosis - Documented CNS involvement - Previous treatment for antecedent hematological disorders (AHD) with 5-azacitidine, decitabine, or low dose cytarabine - Human immunodeficiency virus (HIV) infection Inclusion Criteria for Step 2 (Consolidation) - NOTE: All patients achieving complete remission (CR) or complete remission with incomplete blood count recovery (CRi) will receive consolidation when fit - NOTE: Patients proceeding to transplant are allowed up to one cycle of consolidation treatment - Consolidation cycle 1 must commence within sixty days of the bone marrow aspirate and biopsy that confirmed the presence of a CR or CRi - Patients must have achieved a CR or CRi (or morphologic leukemia-free state for those patients proceeding to Arm G transplant) - Patients who have achieved a CR or CRi must have maintained peripheral blood evidence of a CR or CRi - ECOG performance status of 0-2 - Patients must have resolved any serious infectious complications related to induction - NOTE: Patients with an HLA-matched donor and proceeding to transplant will be allowed up to one cycle of consolidation treatment - Any significant medical complications related to induction must have resolved - Patients must have a creatinine and AST =< grade 1 within 48 hours prior to registration Inclusion Criteria for Step 3 (Maintenance): - Maintenance should commence within 60 days of recovery of peripheral blood counts after consolidation cycle 2; patients must begin consolidation cycle 2 within 60 days of recovery to be eligible for further therapy - Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy and cytogenetic analysis - ECOG performance status of 0 -2 - Patients must have resolved any serious infectious complications related to consolidation cycle 2 - Any significant medical complications related to consolidation cycle 2 must have resolved - Total serum bilirubin =< 1.5 x ULN - NOTE: if total bilirubin is 2-3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible - Serum creatinine =< grade 1 - The absolute neutrophil count (ANC) must be > 1000 mm^3 prior to starting every cycle of treatment with decitabine; decitabine may be delayed for up to 4 weeks between cycles (i.e. may be administered as infrequently as every (q) 8 weeks) while waiting for counts to recover - The platelet count must be > 75,000 mm^3 prior to starting every cycle of treatment with decitabine; decitabine may be delayed for up to 4 weeks between cycles (i.e. may be administered as infrequently as every (q) 8 weeks) while waiting for counts to recover Inclusion Criteria for Step 3 (Allogeneic Transplantation): - Patients must be > 28 days from the start of induction or re-induction chemotherapy, or from the start Consolidation Cycle 1 (if received) and < 90 days following recovery from most recent treatment; and they must have achieved and maintained a response to induction therapy (CR, CRi, or "morphologic disease-free state") - Patients must have recovered from the effects of induction, re-induction, or consolidation chemotherapy (all toxicities =< grade I with the exception of reversible electrolyte abnormalities), and have no ongoing active infection requiring treatment - Patients must have a total serum bilirubin =< 1.5 x ULN (grade =< 1) and a serum creatinine =< grade 1; AST <= grade 1 - An eligible HLA-identical donor (either related or unrelated) should be available; in sibling donors, low resolution HLA typing (A,B,DR) will be considered sufficient; in the case of unrelated donors, high-resolution class I and II typing (A, B, C, DRB1 and DQ) should be matched at all 10 loci; donors must be willing and able to undergo peripheral blood progenitor mobilization - HLA-identical sibling (6/6): the donor must be determined to be an HLA-identical sibling (6/6) by serologic typing for class (A, B) and low resolution molecular typing for class II (DRB1) - Matched unrelated donor (10/10): high resolution molecular typing at the following loci is required: HLA-A, -B, -C, -DRBL, and -DQB1 - NOTE: for matched donors - will allow select 1 antigen mismatched sibling donors and unrelated donors in accordance with site institutional standard, as long as matched at HLA-A, HLA-B, HLA-C, and DRB1, and with advanced discussion/approval by the Study Chair and the bone marrow transplant (BMT) co-chair - Patients must be considered reliable enough to comply with the medication regimen and follow-up, and have social support necessary to allow this compliance - Patients must have a cardiac ejection fraction of >= 40%, or within institutional normal limits; a nuclear medicine gated blood pool examination is preferred; a 2-D ECHO scan is acceptable if a calculated ejection fraction is obtained and follow-up measurement of the cardiac ejection fraction will also be performed by echocardiography; measurement of cardiac ejection fraction should be within two weeks prior to allogeneic transplantation - Diffusion capacity of carbon monoxide (DLCO) > 40% with no symptomatic pulmonary disease Exclusion Criteria for Step 3 (Allogeneic Transplantation): - Hypersensitivity to Escherichia (E.) coli-derived products - Human immunodeficiency virus (HIV) infection; patients with immune dysfunction are at a significantly higher risk of toxicities from intensive immunosuppressive therapies |
Country | Name | City | State |
---|---|---|---|
India | Mayo Clinic Methodist Hospital | Nagpur | |
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 Inc - Kapiolani Medical Center at Pali Momi | 'Aiea | Hawaii |
United States | Akron General Medical Center | Akron | Ohio |
United States | Summa Akron City Hospital | Akron | Ohio |
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Saint Anthony's Health | Alton | Illinois |
United States | McFarland Clinic | Ames | Iowa |
United States | AnMed Health Cancer Center | Anderson | South Carolina |
United States | Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Atlanta Regional CCOP | Atlanta | Georgia |
United States | Northside Hospital | Atlanta | Georgia |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Saint Joseph's Hospital of Atlanta | Atlanta | Georgia |
United States | Georgia Regents University | Augusta | Georgia |
United States | Harold Alfond Center for Cancer Care | Augusta | Maine |
United States | The Medical Center of Aurora | Aurora | Colorado |
United States | Well Star Cobb Hospital | Austell | Georgia |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Summa Barberton Hospital | Barberton | Ohio |
United States | Ochsner Clinic Foundation-Baton Rouge | Baton Rouge | Louisiana |
United States | Bronson Battle Creek | Battle Creek | Michigan |
United States | Saint Francis Hospital and Health Centers | Beech Grove | Indiana |
United States | Sanford Clinic North-Bemidgi | Bemidji | Minnesota |
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania |
United States | Mecosta County Medical Center | Big Rapids | Michigan |
United States | Billings Clinic | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies PC | Billings | Montana |
United States | Montana Cancer Consortium CCOP | Billings | Montana |
United States | Saint Vincent Healthcare | Billings | Montana |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Joseph Medical Center | Bloomington | Illinois |
United States | Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota |
United States | Caritas Saint Elizabeth's Medical Center | Brighton | Massachusetts |
United States | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana |
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
United States | Aultman Health Foundation | Canton | Ohio |
United States | Graham Hospital Association | 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 Charleston | Charleston | West Virginia |
United States | Erlanger Medical Center | Chattanooga | Tennessee |
United States | Hematology and Oncology Associates | Chicago | Illinois |
United States | Mount Sinai Hospital Medical Center | Chicago | Illinois |
United States | Northwestern University | Chicago | Illinois |
United States | University of Illinois | Chicago | Illinois |
United States | The Jewish Hospital | Cincinnati | Ohio |
United States | Clackamas Radiation Oncology Center | Clackamas | Oregon |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | John B Amos Cancer Center | Columbus | Georgia |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Dayton CCOP | 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 | Oakwood Hospital | Dearborn | Michigan |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Dekalb Medical Center | Decatur | Georgia |
United States | Colorado Cancer Research Program CCOP | Denver | Colorado |
United States | Exempla Saint Joseph Hospital | Denver | Colorado |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | Saint Anthony Central Hospital | Denver | Colorado |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Wayne State University | Detroit | Michigan |
United States | Essentia Health Duluth Clinic CCOP | Duluth | Minnesota |
United States | Essentia Health Saint Mary's Medical Center | Duluth | Minnesota |
United States | Miller-Dwan Hospital | Duluth | Minnesota |
United States | Union Hospital of Cecil County | Elkton | Maryland |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Eureka Hospital | Eureka | Illinois |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | Roger Maris Cancer Center | Fargo | North Dakota |
United States | Sanford Clinic North-Fargo | Fargo | North Dakota |
United States | Sanford Medical Center-Fargo | Fargo | North Dakota |
United States | Piedmont Fayette Hospital | Fayetteville | Georgia |
United States | Lake Region Healthcare Corporation-Cancer Care | Fergus Falls | Minnesota |
United States | Blanchard Valley Hospital | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Genesys Regional Medical Center-West Flint Campus | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Fort Wayne Medical Oncology and Hematology Inc - State Boulevard | Fort Wayne | Indiana |
United States | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | University of Florida | Gainesville | Florida |
United States | Illinois CancerCare Galesburg | Galesburg | Illinois |
United States | Western Illinois Cancer Treatment Center | Galesburg | Illinois |
United States | Genesys Regional Medical Center | Grand Blanc | Michigan |
United States | Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan |
United States | Saint Mary's Health Care | 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 | North Colorado Medical Center | Greeley | Colorado |
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 Mary's Hospital | Green Bay | Wisconsin |
United States | Saint Vincent Hospital | Green Bay | Wisconsin |
United States | Saint Francis Hospital | Greenville | South Carolina |
United States | Wayne Hospital | Greenville | Ohio |
United States | Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Illinois CancerCare-Havana | Havana | Illinois |
United States | Mason District Hospital | Havana | Illinois |
United States | Northern Montana Hospital | Havre | Montana |
United States | Geisinger Medical Center-Cancer Center Hazelton | Hazleton | Pennsylvania |
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 | Hinsdale Hematology Oncology Associates Incorporated | Hinsdale | Illinois |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Kuakini Medical Center | Honolulu | Hawaii |
United States | Oncare Hawaii Inc-Kuakini | Honolulu | Hawaii |
United States | Oncare Hawaii Inc-POB II | Honolulu | Hawaii |
United States | OnCare Hawaii-Liliha | Honolulu | Hawaii |
United States | Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital | Honolulu | Hawaii |
United States | University of Hawaii | Honolulu | Hawaii |
United States | Franciscan St. Francis Health | Indianapolis | Indiana |
United States | Allegiance Health | Jackson | Michigan |
United States | Jackson-Madison County General Hospital | Jackson | Tennessee |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Mayo Clinic in Florida | 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 | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Presence Saint Mary's Hospital | Kankakee | Illinois |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Kinston Medical Specialists PA | Kinston | North Carolina |
United States | Gundersen Lutheran | La Crosse | Wisconsin |
United States | Carolina Blood and Cancer Care Associates PA-Lancaster | Lancaster | South Carolina |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada |
United States | Gwinnett Medical Center | Lawrenceville | Georgia |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Lewistown Hospital | Lewistown | Pennsylvania |
United States | University of Kentucky | Lexington | Kentucky |
United States | North Shore Hematology Oncology | Libertyville | Illinois |
United States | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii |
United States | Saint Rita's Medical Center | Lima | Ohio |
United States | Littleton Adventist Hospital | Littleton | Colorado |
United States | Saint Mary Mercy Hospital | Livonia | Michigan |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Longmont United Hospital | Longmont | Colorado |
United States | Norton Health Care Pavilion - Downtown | Louisville | Kentucky |
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 Hospital and Clinics | Madison | Wisconsin |
United States | Holy Family Memorial Hospital | Manitowoc | Wisconsin |
United States | Wellstar Kennestone Hospital | Marietta | Georgia |
United States | Bay Area Medical Center | Marinette | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Winthrop University Hospital | Mineola | New York |
United States | Montana Cancer Specialists | Missoula | Montana |
United States | Saint Patrick Hospital - Community Hospital | Missoula | Montana |
United States | Holy Family Medical Center | Monmouth | Illinois |
United States | Illinois CancerCare-Monmouth | Monmouth | Illinois |
United States | West Virginia University | Morgantown | West Virginia |
United States | D N Greenwald Center | Mukwonago | Wisconsin |
United States | Mercy Health Partners-Mercy Campus | Muskegon | Michigan |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | The Hospital of Central Connecticut | New Britain | Connecticut |
United States | Ochsner Baptist Medical Center | New Orleans | Louisiana |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | Providence Newberg Medical Center | Newberg | Oregon |
United States | Illinois Cancer Specialists-Niles | Niles | Illinois |
United States | Bromenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center Foundation | Normal | Illinois |
United States | Illinois CancerCare-Community Cancer Center | Normal | Illinois |
United States | Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc | Wisconsin |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Providence Willamette Falls Medical Center | Oregon City | Oregon |
United States | Florida Hospital | Orlando | Florida |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois |
United States | Parker Adventist Hospital | Parker | Colorado |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | Pekin Cancer Treatment Center | Pekin | Illinois |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Illinois Oncology Research Association CCOP | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Illinois Valley Hospital | Peru | Illinois |
United States | Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Saint Joseph Mercy Port Huron | Port Huron | Michigan |
United States | Columbia River Oncology Program | Portland | Oregon |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | Providence Saint Vincent Medical Center | Portland | Oregon |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
United States | Reid Hospital and Health Care Services | Richmond | Indiana |
United States | Southern Regional Medical Center | Riverdale | Georgia |
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 | Swedish American Hospital | Rockford | Illinois |
United States | Harbin Clinic Medical Oncology and Clinical Research | Rome | Georgia |
United States | Saint Mary's of Michigan | Saginaw | Michigan |
United States | Saint John's Mercy Medical Center | Saint Louis | Missouri |
United States | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri |
United States | Saint Louis University Hospital | Saint Louis | Missouri |
United States | Saint Louis-Cape Girardeau CCOP | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
United States | Saint Nicholas Hospital | Sheboygan | Wisconsin |
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 Hematology Oncology Associates | Sioux City | Iowa |
United States | Medical X-Ray Center | Sioux Falls | South Dakota |
United States | Sanford Cancer Center-Oncology Clinic | Sioux Falls | South Dakota |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Hematology Oncology Associates of Illinois - Skokie | Skokie | Illinois |
United States | Providence Hospital | Southfield | Michigan |
United States | Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Upstate Carolina CCOP | Spartanburg | South Carolina |
United States | Illinois CancerCare-Spring Valley | Spring Valley | Illinois |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Geisinger Medical Group | 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 | Upper Valley Medical Center | Troy | Ohio |
United States | Arizona Cancer Center at University Medical Center North | Tucson | Arizona |
United States | University of Arizona Health Sciences Center | Tucson | Arizona |
United States | Northwest Cancer Specialists | Vancouver | Washington |
United States | PeaceHealth Southwest Medical Center | Vancouver | Washington |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Waukesha Memorial Hospital - ProHealth Care | Waukesha | Wisconsin |
United States | Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin |
United States | Exempla Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania |
United States | Clinton Memorial Hospital | Wilmington | Ohio |
United States | Greene Memorial Hospital | Xenia | Ohio |
United States | York Hospital | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
ECOG-ACRIN Cancer Research Group | National Cancer Institute (NCI) |
United States, India, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Expression and Methylation Profiling | DNA methylation profiling and gene expression are evaluated using peripheral blood samples collected at baseline of the maintenance treatment (prior to 2nd randomization). These are to be compared between patients with decitabine and patients on observation. | Baseline of maintenance treatment | |
Other | Relapse After Decitabine Maintenance by Epigenetic Signature of Normal Bone Marrow | To examine the epigenetic profiles of remission marrow among patients randomized to observation vs. decitabine to determine whether epigenetic signature of apparently morphologically normal bone marrow is predictive of relapse or response to decitabine maintenance.
Relapse following complete remission is defined as: Peripheral Blood Counts Reappearance of blasts in the blood Bone Marrow Aspirate and Biopsy Presence of > 5% blasts, not attributable to another cause (e.g., bone marrow regeneration). If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed = 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse. |
Assessed every 3 months for 4 years and then every 6 months for 1 year | |
Other | Complete Remission Rate by ABC-transporter P-glycoprotein (Pgp) | Patients with all the following are considered as having a complete remission.
Peripheral Blood Counts Neutrophil count > 1.0 x 109 /L Platelet count = 100 x 109 /L Reduced hemoglobin concentration or hematocrit has no bearing on remission status Leukemic blasts must not be present in the peripheral blood Bone Marrow Aspirate and Biopsy Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines < 5% blasts by morphologic review Auer rods must not be detectable Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present The proportion of patients with complete remission will be compared between patients who overexpress Pgp and patients who do not overexpress Pgp. |
Assessed every 3 months for 4 years and then every 6 months for 1 year | |
Other | To Assess the Intensity of Expression of CXCR4 on Diagnostic Leukemia Cells and to Correlate This Parameter With Other Established Prognostic Factors | Expression of CXCR4 will be assessed in this study by flow cytometric assay. The associations between the expression level and other prognostic factors in patients receiving induction treatment will be evaluated. | Baseline | |
Other | The Association Between Somatic Mutations and Relapse | Relapse following complete remission is defined as:
Peripheral Blood Counts Reappearance of blasts in the blood Bone Marrow Aspirate and Biopsy Presence of > 5% blasts, not attributable to another cause (e.g., bone marrow regeneration). If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed = 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse. |
Assessed every 3 months for 4 years and then every 6 months for 1 year | |
Other | Overall Survival by Patient Characteristics and Lifestyle | Overall survival is defined as time from randomization to death or date last known alive. The associations between overall survival and smoking status, obesity, regular acetaminophen use, regular aspirin use, benzene exposure, living in a rural/farm environment and some other underlying exposures and lifestyle factors will be evaluated. | Assessed every 3 months for 4 years and then every 6 months for 1 year | |
Other | Copy Number Changes Using Array Comparative Genomic Hybridization (CGH) by Patient Characteristics | Copy number changes will be tested based on array CGH technology. The associations between copy number changes and acute myeloid leukemia patient characteristics will be evaluated. | Baseline | |
Other | Quality of Life (QOL) Assessed by Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) | QOL will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu). This instrument combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL. | Assessed at baseline, 14 days after 1st induction treatment, prior to consolidation therapy (day 35-36), prior to maintenance treatment, end of maintenance treatment | |
Other | Change in Health-related QOL Over Time | QOL will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu). This instrument combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL.
Changes in QOL will be calculated by subtracting baseline QOL score from follow-up QOL score. |
Assessed at baseline, 14 days after 1st induction treatment, prior to consolidation therapy (day 35-36), prior to maintenance treatment, end of maintenance treatment | |
Other | Patient Function Assessed by Functional Assessment of Cancer Therapy - General (FACT-G) | QOL will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G). FACT-G includes 4 subscales, physical well-being (score range: 0-28), social/family well-being (score range: 0-28), emotional well-being (score range: 0-24), and functional well-being (score range: 0-28). The total score of FACT-G ranges between 0 and 108. Higher score indicates better QOL. | Assessed at baseline | |
Other | Change in QOL Post Transplant From Baseline | For those patients who go to allo transplant, the FACT-Leu and the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) instruments will be administered at the beginning of the conditioning regimen and 100 days (+14 days) post transplant.
FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL. FACIT-Fatigue has 13 items and the total score ranges between 0 and 52. Higher score indicates better QOL. Changes in QOL will be calculated by subtracting baseline QOL score from follow-up QOL score. |
Assessed prior to transplant and 100 days after transplant | |
Other | Baseline QOL Scores by Treatment Completion Status | The associations between baseline QOL scores and the ability to finish treatment will be evaluated. Baseline QOL will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) and the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue).
FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL. FACIT-Fatigue has 13 items and the total score ranges between 0 and 52. Higher score indicates better QOL. |
Assessed at baseline | |
Primary | Overall Survival | Overall survival is defined as the time from randomization to death or date last known alive. | Assessed every 3 months for 4 years and then every 6 months for 1 year | |
Secondary | Proportion of Patients With Complete Remission | Patients are required to have all of the following to be considered as having a completion remission (CR).
Peripheral Blood Counts Neutrophil count > 1.0 x 10^9 /L Platelet count = 100 x 10^9 /L Reduced hemoglobin concentration or hematocrit has no bearing on remission status Leukemic blasts must not be present in the peripheral blood Bone Marrow Aspirate and Biopsy Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines < 5% blasts by morphologic review Auer rods must not be detectable Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present |
Assessed every 3 months for 4 years and then every 6 months for 1 year | |
Secondary | Overall Survival by Donor Status | Overall survival is defined as time between achieving leukemia-free state after induction therapy to death from any cause or date last known alive. The association between overall survival and donor status was evaluated regardless of assigned treatment arms. Patients with transplant donor information (either had donor or did not have a donor) reported after achieving CR/Cri/leukemia-free state post induction therapy were included in this analysis. | Assessed every 3 months for 4 years and then every 6 months for 1 year | |
Secondary | Disease-free Survival for Maintenance | DFS for maintenance comparison is defined as the time from maintenance randomization until relapse or death of any cause. The censored follow-up time for patients without relapse and death information is the date of last contact. Only patients who remained in CR or CRi after completion of consolidation therapy that were randomized to either observation or decitabine in the maintenance Step were included in this analysis. | Assessed every 3 months for 4 years and then every 6 months for 1 year |
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