Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
VALOR
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)
2 other identifiers
interventional
711
14 countries
120
Brief Summary
This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2010
Longer than P75 for phase_3
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2010
CompletedFirst Posted
Study publicly available on registry
August 31, 2010
CompletedStudy Start
First participant enrolled
December 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedResults Posted
Study results publicly available
May 9, 2017
CompletedAugust 22, 2018
March 1, 2017
3.8 years
August 27, 2010
April 12, 2016
July 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
Up to 5 years or duration of study
Secondary Outcomes (3)
Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.
Up to 5 years or duration of study
All Cause Mortality
30 Days
All Cause Mortality
60 Days
Other Outcomes (3)
Overall Remission (OR) Rate Based on the IWG Response Criteria
Up to 5 years or the duration of the study
Event Free Survival (EFS)
Up to 5 years or duration of study
Leukemia-Free Survival (LFS)
Up to 5 years or the duration of the study
Study Arms (2)
Group A: vosaroxin + cytarabine
EXPERIMENTALvosaroxin (short IV infusion within 10 minutes) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation
Group B: placebo + cytarabine
PLACEBO COMPARATORplacebo (short IV infusion within 10 minutes and volume matched to vosaroxin) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation
Interventions
Vosaroxin days 1 and 4: 90 mg/m2 for induction 1; 70 mg/m2 for all other cycles Cytarabine 1 g/m2 daily on days 1-5 (IDAC)
Placebo days 1 and 4: volume matched to vosaroxin Cytarabine 1 g/m2 daily on days 1-5 (IDAC)
Eligibility Criteria
You may qualify if:
- Provided signed, written informed consent
- At least 18 years of age
- Had a diagnosis of AML according to World Health Organization (WHO) classification
- First relapsed or refractory AML (refractory to initial induction therapy) with at least 5% blasts by bone marrow or aspirate or 1% blasts in peripheral blood with additional requirements for relapsed or refractory
- Had an ECOG score of 0-2
- Had adequate liver and renal function as indicated by certain laboratory values
- Had adequate cardiac function (left ventricular ejection fraction at least 40% by multiple gated acquisition scan or ECG)
- Nonfertile or agreed to use an adequate method of contraception until 30 days after the last treatment
- Had any clinically significant nonhematologic toxicity after prior chemotherapy recovered to Grade 1 per NCI-CTCAE
You may not qualify if:
- Had acute promyelocytic leukemia
- Had more than 2 cycles of induction therapy for AML
- Had completed a single cycle of treatment containing a total dose of 5 g/m2 or more of cytarabine within 90 days before randomization
- Refractory to or relapsed within the previous 3 months after therapy with an IDAC- or HIDAC-containing regimen
- Had received a hematopoietic stem cell transplant (HSCT) within the previous 90 days
- Had received active immunosuppressive therapy for graft-versus-host disease (GVHD) within 2 weeks before study start
- Had any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system
- Had evidence of central nervous system involvement of active AML
- Had other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
- Had an active, uncontrolled infection
- Had received any other investigational therapy within 14 days or not recovered from acute affects of the other investigational therapy
- Had received prior or current hydroxyurea or medications to reduce blast count within 24 hours before randomization
- Had received previous treatment with vosaroxin
- Pregnant or lactating
- Had any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (124)
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
UCLA Division of Hematology/Oncology
Los Angeles, California, 90095, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
University of California San Francisco
San Francisco, California, 94143, United States
HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, 80218, United States
George Washington University-Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Georgia Health Sciences University
Augusta, Georgia, 30912, United States
Rush University Medical Center, Division of Hematology/Oncology
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, 46237, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Ellis Fischel Cancer Center, University of Missouri Health Care
Columbia, Missouri, 65203, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
North Shore Long Island Jewish Health System
Lake Success, New York, 11042, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 100065, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
New York Medical College, Division of Oncology/Hematology
Valhalla, New York, 10595, United States
Mecklenburg Medical Group
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University Hospitals fo Cleveland
Cleveland, Ohio, 44106, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Family Cancer Center
Memphis, Tennessee, 38119, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia
Houston, Texas, 77030, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78229, United States
Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University
Morgantown, West Virginia, 26506, United States
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Haematology Department, Gosford Hospital
Gosford, New South Wales, 2250, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Andrew Love Cancer Center, Geelong Hospital, Barwon Health
Geelong, Victoria, 3220, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie
Graz, 8036, Austria
University Hospital for Internal Medicine V, Innsbruck Medical University
Innsbruck, 6020, Austria
Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU
Salzburg, 5020, Austria
AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1
Vienna, 1090, Austria
ZNA Middleheim Lindendreef 1
Antwerp, 2020, Belgium
ZNA Stuivenberg, Lange Beeldekensstraat 267
Antwerp, Belgium
AZ St.-Jan Brugge-Oostende AV
Bruges, 8000, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
UZ Leuven, campus Gasthuisberg, Department of Haematology
Leuven, B 3000, Belgium
H.-Hartziekenhuis Roeselare - Menen vzw
Roeselare, 8800, Belgium
Division of Hematology, Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Charles LeMoyne Hospital
Greenfield Park, Quebec, J4V 2H1, Canada
Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie
Prague, Srobarova, 100 34 Praha 10, Czechia
Fakultni nemocnice Brno, Interni hematoonkologicka klinika
Brno, 625 00, Czechia
Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie
Hradec KrĂ¡lovĂ©, 500 05, Czechia
CHU Lille, Service des maladies du sang, Hopital Huriez
Lille, Lille Cedex, 59037, France
CHU Angers, Service des maladies du sang
Angers, 49033, France
Hopital Avicenne- Departement Onco-hematologie
Bobigny, 93000, France
Hopital Mignot
Le Chesnay, 78157, France
Institut Paoli Calmettes
Marseille, 13009, France
CHU Nantes Hotel Dieu, Service d'hematologie clinique
Nantes, 44093, France
CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle
Pessac, 33604, France
Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet
Pierre-BĂ©nite, 69495, France
Service d'hematologie- Hopital Purpan- CHU de Toulouse
Toulouse, 31059, France
St. Johannes-Hospital
Duisburg, 47166, Germany
Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt
Frankfurt, 65929, Germany
Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation
Hamburg, 20246, Germany
Medizinische Hochschule Hannover, Abteilung Hamatologie
Hanover, 30625, Germany
SLK-Kliniken Heilbronn GmbH, Medizinische Klinik
Heilbronn, 74078, Germany
Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik
Kiel, 24116, Germany
Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie
Leipzig, 04129, Germany
Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik
Munich, 81675, Germany
University Hospital of Muenster
MĂ¼nster, 48149, Germany
University of Debrecen Medical and Health Sciences Center
Debrecen, H-4030, Hungary
Petz Aladar County Hospital
Győr, H-9024, Hungary
kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly
KaposvĂ¡r, H-7400, Hungary
Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika
Szeged, H-6720, Hungary
Ospedale "A. Perrino", U.O. Compessa di Ematologia
Brindisi, 72100, Italy
Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate
Ferrara, 44121, Italy
Ospedaliera Universitaria San Martino di Genova
Genova, 16132, Italy
Ospedale "Vito Fazzi", U.O Ematologia
Lecce, 73100, Italy
AORN "A. Cardarelli", U.O.S.C. Ematologia con TMO
Napoli, 80131, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia
Novara, 28100, Italy
Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia
Pavia, 27100, Italy
Haematology Research, Auckland District Health Board, Auckland City Hospital
Grafton, Auckland, 1023, New Zealand
Canterbury Health Laboratories
Christchurch, 8011, New Zealand
Department of Haematology, Waikato Hospital
Hamilton, 3240, New Zealand
Regional Cancer Treatment Service, Palmerston North Hospital
Palmerston North, 4414, New Zealand
Uniwersyteckle Centrum Kliniczne
Gdansk, 80-952, Poland
Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-569, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, 50-369, Poland
Seoul National University Hospital
Seoul, 110-744, South Korea
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710, South Korea
Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
Dept. of Hematology, Asan Medical Center
Seoul, 138-736, South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital del Mar
Barcelona, Spain
Centro Oncologico MD Anderson International Espana
Madrid, 28033, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Sont Llatzer
Palma de Mallorca, 07198, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitari Politecnic la Fe Hematology Department
Valencia, 46026, Spain
Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, FY3 8NR, United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Department of Haematology, University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Queen's Centre for Oncology and Hematology, Castle Hill Hospital
Cottingham, GY16 5JQ, United Kingdom
Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust
Leicester, LE1 5WW, United Kingdom
Department of Haematology, Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
Department of Haematology, Guy's Hospital
London, SE1 9RT, United Kingdom
Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Related Publications (1)
Ravandi F, Ritchie EK, Sayar H, Lancet JE, Craig MD, Vey N, Strickland SA, Schiller GJ, Jabbour E, Erba HP, Pigneux A, Horst HA, Recher C, Klimek VM, Cortes J, Roboz GJ, Odenike O, Thomas X, Havelange V, Maertens J, Derigs HG, Heuser M, Damon L, Powell BL, Gaidano G, Carella AM, Wei A, Hogge D, Craig AR, Fox JA, Ward R, Smith JA, Acton G, Mehta C, Stuart RK, Kantarjian HM. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2015 Sep;16(9):1025-1036. doi: 10.1016/S1470-2045(15)00201-6. Epub 2015 Jul 30.
PMID: 26234174DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Judy Fox, Chief Scientific Officer
- Organization
- Sunesis Pharmaceuticals, Inc
Study Officials
- STUDY DIRECTOR
Linda Neuman, MD
Sunesis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2010
First Posted
August 31, 2010
Study Start
December 17, 2010
Primary Completion
September 26, 2014
Study Completion
March 1, 2017
Last Updated
August 22, 2018
Results First Posted
May 9, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
De-identified data of individual participants experiencing Serious Adverse Events