Spots Global Cancer Trial Database for Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
Official Title: Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration
Study ID: NCT00822094
Conditions
Study Description
Brief Summary: The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens. The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.
Detailed Description: This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or intensive first salvage treatment. Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Cancer Center, Tucson, Arizona, United States
UCLA, Los Angeles, California, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
UC Davis Cancer Center, Sacramento, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Northwestern University Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago Medical Center Section of Hematology/Oncology, Chicago, Illinois, United States
St. Francis Cancer Center, Beech Grove, Indiana, United States
University of Louisville Brown Cancer Center, Louisville, Kentucky, United States
Maine General Medical Center Harold Alfond Center for Cancer Care, Waterville, Maine, United States
Johns Hopkins University, Baltimore, Maryland, United States
St. Louis University Medical Center, Saint Louis, Missouri, United States
The Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, United States
North Shore LIJ Center for Advanced Medicine Monter Cancer Center, Lake Success, New York, United States
Weil Cornell Medical Center, New York, New York, United States
New York Medical College, New York, New York, United States
Montefiore Medical Center, The Bronx, New York, United States
Blumenthal Cancer Center/Mecklenburg Medical Group, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Jewish Hospital of Cincinatti, Cincinnati, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Oncology and Hematology at Lehigh Valley, Bethlehem, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
UTMB Comprehensive Cancer Center, Galveston, Texas, United States
M.D. Anderson Cancer Center, Houston, Texas, United States
Joe Arrington Cancer Center, Lubbock, Texas, United States
Texas Tech University Health Sciences Center, Lubbock, Texas, United States
Cancer Therapy and Research Center at The University of TX Health Science Center, San Antonio, Texas, United States
Intermountain LDS Hospital, Salt Lake City, Utah, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Vancouver General Hospital/ British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
Service des Maladies du Sang CHU de Lille, Hopital Claude Huriez, Lille Cedex, , France
Service des Maladies du Sang Hopital Haut-Leveque, Pessac, , France
Service d'Hématologie CHU Toulouse-Hôpital Purpan, Toulouse Cedex 09, , France
Service d'Hématologie et Médecine Interne CHU de Nancy-Hôpital de Brabois, Vandoeuvre les Nancy Cedex, , France
Klinika Hematologii i Transplantologii, Gdansk, , Poland
Wojewódzki Szpital Specjalistyczny im. M. Kopernika, Lodz, , Poland
Oddział Hematologii, Opole, , Poland
Instytut Hematologii i Transfuzjologii, Warszawa, , Poland
Akademia Medyczna we Wroclawlu, Wroclaw, , Poland
Contact Details
Name: Jonathan Kolitz, MD
Affiliation: North Shore University Hospital
Role: PRINCIPAL_INVESTIGATOR
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