The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
Official Title: A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)
Study ID: NCT01191801
Brief Summary: This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.
Detailed Description: The study includes additional objectives to ones listed above as Outcome Measures. These additional objectives also compared treatment groups in the following: CR + CRp rate, defined as CR + CRp based on modified IWG response criteria. Combined CR rate (CR+CRp+CRi). Percentage of patients who have post-treatment (subsequent) transplantation. Percentage of patients who received subsequent non-protocol therapy (including transplantation). Safety and tolerability. In keeping with FDA guidance for adaptive trial designs, the study incorporated an independent DSMB (Drug Safety Monitoring Board) to address potential uncertainty concerning the true treatment affect between the treatment groups and to address a deterioration of power from a small difference. Sunesis remained blinded and had no involvement in the interim data analysis, interpretation, or adaptive design. Based on the results of the interim data analysis the DSMB recommended an increase in the target number of deaths from 375 in 450 patients to 562 in 675 patients which based on a 5% dropout rate increased enrollment from 475 to 712. The primary analysis was performed when the target number of deaths had been achieved based on a permuted block randomization procedure, stratified by disease status (refractory, first relapse with duration of first CR or CRp ≥ 90 days and \< 12 months, or first relapse with duration of first CR or CRp ≥ 12 months and ≤ 24 months), age (\< 60 years or ≥ 60 years), and geographic location (US or outside US). The study included periods of screening, treatment / hematologic recovery, post-treatment follow-up, and long-term follow-up for survival. Follow-up was monthly during the first year, every 2 months during the second year, and every 3 months thereafter until death, withdrawal of consent, or loss to follow-up, whichever occurred first. Long-term follow-up began for all patients when the required number of deaths for primary analysis had been met; thereafter, survival data were collected every 4 months until death, withdrawal of consent, or loss to follow-up, whichever occurred first. The long term follow-up for this study continues at this time and the September 2014 date reflects database lock for primary analyses reflected in the Results Section. During long term follow-up Sunesis is not collecting Adverse Events.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Moores UCSD Cancer Center, La Jolla, California, United States
UCLA Division of Hematology/Oncology, Los Angeles, California, United States
Sharp Clinical Oncology Research, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program, Denver, Colorado, United States
George Washington University-Medical Faculty Associates, Washington, District of Columbia, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
Baptist Cancer Institute, Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Georgia Health Sciences University, Augusta, Georgia, United States
Rush University Medical Center, Division of Hematology/Oncology, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
St. Francis Medical Group Oncology and Hematology Specialists, Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
University of Michigan, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Ellis Fischel Cancer Center, University of Missouri Health Care, Columbia, Missouri, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
North Shore Long Island Jewish Health System, Lake Success, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
New York Medical College, Division of Oncology/Hematology, Valhalla, New York, United States
Mecklenburg Medical Group, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
University Hospitals fo Cleveland, Cleveland, Ohio, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Family Cancer Center, Memphis, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic, Nashville, Tennessee, United States
UT Southwestern Medical Center at Dallas, Dallas, Texas, United States
The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia, Houston, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University, Morgantown, West Virginia, United States
The Canberra Hospital, Garran, Australian Capital Territory, Australia
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Haematology Department, Gosford Hospital, Gosford, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Andrew Love Cancer Center, Geelong Hospital, Barwon Health, Geelong, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital, Parkville, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie, Graz, , Austria
University Hospital for Internal Medicine V, Innsbruck Medical University, Innsbruck, , Austria
Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU, Salzburg, , Austria
AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1, Wien, , Austria
ZNA Middleheim Lindendreef 1, Antwerpen, , Belgium
ZNA Stuivenberg, Lange Beeldekensstraat 267, Antwerpen, , Belgium
AZ St.-Jan Brugge-Oostende AV, Brugge, , Belgium
Cliniques Universitaires Saint Luc, Brussels, , Belgium
UZ Leuven, campus Gasthuisberg, Department of Haematology, Leuven, , Belgium
H.-Hartziekenhuis Roeselare - Menen vzw, Roeselare, , Belgium
Division of Hematology, Vancouver General Hospital, Vancouver, British Columbia, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada
University Health Network, Princess Margaret Hospital, Toronto, Ontario, Canada
Charles LeMoyne Hospital, Greenfield Park, Quebec, Canada
Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie, Praha, Srobarova, Czechia
Fakultni nemocnice Brno, Interni hematoonkologicka klinika, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie, Hradec Kralove, , Czechia
CHU Lille, Service des maladies du sang, Hopital Huriez, Lille, Lille Cedex, France
CHU Angers, Service des maladies du sang, Angers Cedex 01, , France
Hopital Avicenne- Departement Onco-hematologie, Bobigny, , France
Hopital Mignot, Le Chesnay, , France
Institut Paoli Calmettes, Marseille, , France
CHU Nantes Hotel Dieu, Service d'hematologie clinique, Nantes, , France
CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle, Pessac, , France
Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet, Pierre Benite, , France
Service d'hematologie- Hopital Purpan- CHU de Toulouse, Toulouse, , France
St. Johannes-Hospital, Duisburg, , Germany
Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt, Frankfurt, , Germany
Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation, Hamburg, , Germany
Medizinische Hochschule Hannover, Abteilung Hamatologie, Hannover, , Germany
SLK-Kliniken Heilbronn GmbH, Medizinische Klinik, Heilbronn, , Germany
Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik, Kiel, , Germany
Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie, Leipzig, , Germany
University Hospital of Muenster, Muenster, , Germany
Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik, Munich, , Germany
University of Debrecen Medical and Health Sciences Center, Debrecen, , Hungary
Petz Aladar County Hospital, Gyor, , Hungary
kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly, Kaposvar, , Hungary
Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika, Szeged, , Hungary
Ospedale "A. Perrino", U.O. Compessa di Ematologia, Brindisi, , Italy
Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate, Ferrara, , Italy
Ospedaliera Universitaria San Martino di Genova, Genova, , Italy
Ospedale "Vito Fazzi", U.O Ematologia, Lecce, , Italy
AORN "A. Cardarelli", U.O.S.C. Ematologia con TMO, Napoli, , Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia, Novara, , Italy
Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia, Pavia, , Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Dept. of Hematology, Asan Medical Center, Seoul, , Korea, Republic of
Haematology Research, Auckland District Health Board, Auckland City Hospital, Grafton, Auckland, New Zealand
Canterbury Health Laboratories, Christchurch, , New Zealand
Department of Haematology, Waikato Hospital, Hamilton, , New Zealand
Regional Cancer Treatment Service, Palmerston North Hospital, Palmerston North, , New Zealand
Uniwersyteckle Centrum Kliniczne, Gdansk, , Poland
Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznan, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw, , Poland
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Centro Oncologico MD Anderson International Espana, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Sont Llatzer, Palma de Mallorca, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitari Politecnic la Fe Hematology Department, Valencia, , Spain
Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, , United Kingdom
Department of Haematology, University Hospital of Wales, Cardiff, , United Kingdom
Queen's Centre for Oncology and Hematology, Castle Hill Hospital, Cottingham, , United Kingdom
Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust, Leicester, , United Kingdom
Department of Haematology, Royal Liverpool University Hospital, Liverpool, , United Kingdom
Department of Haematology, Guy's Hospital, London, , United Kingdom
Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary, Manchester, , United Kingdom
Name: Linda Neuman, MD
Affiliation: Sunesis Pharmaceuticals
Role: STUDY_DIRECTOR