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Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia

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Trial Identification

Brief Title: Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia

Official Title: A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation

Study ID: NCT00049517

Conditions

Leukemia

Study Description

Brief Summary: RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.

Detailed Description: OBJECTIVES: * To compare the overall survival (OS) between two induction regimens (standard versus dose intense daunorubicin and cytarabine) in patients with de novo AML. * To compare disease-free survival (DFS) between two consolidation regimens. * To compare overall survival between two consolidation regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to induction therapy (standard-dose daunorubicin vs high-dose daunorubicin). * Induction therapy: Patients are randomized to 1 of 2 induction arms. * Standard: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. * High dose: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients in both arms may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. The second course is administered as in arm I to all patients. Patients who don't achieve CR after 2 courses of induction therapy are removed from study. Patients who achieve CR after induction therapy proceed to post-remission therapy with EITHER allogeneic transplantation only (on or off study) OR consolidation therapy and autologous transplantation (on study), according to risk status and donor status. Patients who are considered at intermediate or high risk for relapse (unfavorable cytogenetics/high WBC) and have a suitable related donor undergo an allogeneic transplantation. Patients with intermediate-risk cytogenetics, WBC no greater than 100,000/mm\^3, and appropriate donors have the option of undergoing allogeneic transplantation. * Allogeneic transplantation: Within 1-3 months after recovery from induction therapy, patients receive busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 4 hours on days -3 and -2. Allogeneic bone marrow or peripheral blood stem cells (PBSCs) are infused on day 0. Patients receive graft-vs-host disease (GVHD) prophylaxis comprising cyclosporine IV over 1-4 hours beginning on day -1 and then orally (when tolerated) twice daily until day 180. Alternatively, patients may receive tacrolimus IV over 24 hours beginning on day -1 and then orally twice daily until day 180. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Patients who do not meet the criteria for allogeneic transplantation (i.e., are favorable risk or do not have a matching related donor) or who opt not to undergo allogeneic transplantation proceed to consolidation therapy followed by randomization to 1 of 2 autologous transplantation arms. * Consolidation therapy: Beginning 2-8 weeks after recovery from induction therapy, patients receive high-dose cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. A second course is administered 3 weeks after blood recovery. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 4 days and then autologous PBSCs are harvested by leukapheresis. * Autologous stem cell transplantation: Patients are randomized to 1 of 2 autologous transplantation arms. * Arm I: Within 1 month after PBSC collection, patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous PBSC transplantation on day 0. Patients receive sargramostim (GM-CSF) or G-CSF IV or SC beginning on day 0 and continuing until blood counts recover. * Arm II (closed to accrual as of 10/4/2007): Within 2-4 weeks after PBSC collection, patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I. Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months for up to 7 years. ACTUAL ACCRUAL: A total of 657 patients were accrued for this study.

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama, United States

Mayo Clinic Scottsdale, Scottsdale, Arizona, United States

Aurora Presbyterian Hospital, Aurora, Colorado, United States

Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States

St. Anthony Central Hospital, Denver, Colorado, United States

Porter Adventist Hospital, Denver, Colorado, United States

Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States

St. Joseph Hospital, Denver, Colorado, United States

Rose Medical Center, Denver, Colorado, United States

CCOP - Colorado Cancer Research Program, Denver, Colorado, United States

Swedish Medical Center, Englewood, Colorado, United States

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado, United States

North Colorado Medical Center, Greeley, Colorado, 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

St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States

North Suburban Medical Center, Thornton, Colorado, United States

Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West, Boca Raton, Florida, United States

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus, Boca Raton, Florida, United States

University of Florida Shands Cancer Center, Gainesville, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

Hematology and Oncology Associates, Chicago, Illinois, United States

Evanston Northwestern Healthcare - Evanston Hospital, Evanston, Illinois, United States

Midwest Center for Hematology/Oncology, Joliet, Illinois, United States

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States

North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, United States

La Grange Oncology Associates - Geneva, Naperville, Illinois, United States

Cancer Care and Hematology Specialists of Chicagoland - Niles, Niles, Illinois, United States

Advocate Lutheran General Cancer Care Center, Park Ridge, Illinois, United States

Hematology Oncology Associates - Skokie, Skokie, Illinois, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

Tufts-NEMC Cancer Center, Boston, Massachusetts, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

MeritCare Bemidji, Bemidji, Minnesota, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States

Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States

CCOP - Montana Cancer Consortium, Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States

Northern Rockies Radiation Oncology Center, Billings, Montana, United States

St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States

Billings Clinic - Downtown, Billings, Montana, United States

Bozeman Deaconess Cancer Center, Bozeman, Montana, United States

St. James Healthcare Cancer Care, Butte, Montana, United States

Great Falls Clinic - Main Facility, Great Falls, Montana, United States

Great Falls Clinic, Great Falls, Montana, United States

St. Peter's Hospital, Helena, Montana, 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

Community Medical Center, Missoula, Montana, United States

Guardian Oncology and Center for Wellness, Missoula, Montana, United States

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States

Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States

NYU Cancer Institute at New York University Medical Center, New York, New York, United States

CCOP - MeritCare Hospital, Fargo, North Dakota, United States

MeritCare Broadway, Fargo, North Dakota, United States

Mercy Cancer Center at Mercy Medical Center, Canton, Ohio, United States

Aultman Cancer Center at Aultman Hospital, Canton, Ohio, United States

Jewish Hospital Cancer Center, Cincinnati, Ohio, United States

St. Rita's Medical Center, Lima, Ohio, United States

Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States

UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States

Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States

Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin, United States

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States

Saint Joseph's Hospital, Marshfield, Wisconsin, United States

Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin, United States

Marshfield Clinic - Weston Center, Weston, Wisconsin, United States

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States

Rambam Medical Center, Haifa, , Israel

Contact Details

Name: Hugo F. Fernandez, MD

Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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