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Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (AML)

Information source: Sunesis Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Acute Myeloid Leukemia; Acute Nonlymphocytic Leukemia

Intervention: vosaroxin and cytarabine (Drug); placebo and cytarabine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Sunesis Pharmaceuticals

Official(s) and/or principal investigator(s):
Sunesis Medical Monitor, MD, Study Director, Affiliation: Sunesis Pharmaceuticals

Summary

This study will compare the overall survival (OS) between treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall survival

Secondary outcome: CR rate

Detailed description: Other objectives of this study include comparing the following between treatment groups: Complete remission (CR) rate Safety and tolerability Combined CR rate, defined as CR+CRp+CRi Overall remission (OR) rate Event-free survival (EFS) Durability of remission (CR and combined CR) assessed by leukemia-free survival (LFS) Percentage of patients who have post-treatment transplantation

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Provide signed, written informed consent

- Are at least 18 years of age

- Have a diagnosis of AML according to World Health Organization (WHO) classification

- First relapsed or refractory AML (refractory to initial induction therapy)

- Have an ECOG score of 0-2

- Have adequate liver and renal function as indicated by certain laboratory values

- Are nonfertile or agree to use an adequate method of contraception until 30 days

after the last treatment Exclusion Criteria:

- Have received more than 2 cycles of induction therapy for AML

- Refractory to or relapsed within the previous 3 months after therapy with an IDAC- or

HIDAC-containing regimen

- Have received a hematopoietic stem cell transplant (HSCT) within the previous 3

months

- Have received active immunosuppressive therapy for graft-versus-host disease (GVHD)

within 2 weeks before study start

- Have any other severe concurrent disease, or have a history of serious disease

involving the heart, kidney, liver, or other organ system

- Have evidence of central nervous system involvement of active AML

- Have 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

- Have an active, uncontrolled infection

- Are receiving any other investigational therapy

- Have received previous treatment with vosaroxin

- Are pregnant or lactating

- Have any other medical, psychological, or social condition that may interfere with

consent, study participation, or follow-up

Locations and Contacts

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, Wien 1090, Austria

ZNA Middleheim Lindendreef 1, Antwerpen 2020, Belgium

ZNA Stuivenberg, Lange Beeldekensstraat 267, Antwerpen, Belgium

AZ St.-Jan Brugge-Oostende AV, Brugge 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

Fakultni nemocnice Brno, Interni hematoonkologicka klinika, Brno 625 00, Czech Republic

Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie, Hradec Kralove 500 05, Czech Republic

CHU Angers, Service des maladies du sang, Angers Cedex 01 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 Benite 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, Hannover 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

University Hospital of Muenster, Muenster 48149, Germany

Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik, Munich 81675, Germany

University of Debrecen Medical and Health Sciences Center, Debrecen H-4030, Hungary

Petz Aladar County Hospital, Gyor H-9024, Hungary

kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly, Kaposvar 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

Dept. of Hematology, Asan Medical Center, Seoul 138-736, Korea, Republic of

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, Korea, Republic of

Seoul National University Hospital, Seoul 110-744, Korea, Republic of

Seoul St. Mary's Hospital, Seoul 137-701, Korea, Republic of

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

Hospital Universitari Germans Trias i Pujol, Badalona (Barcelona) 08916, Spain

Hospital de la Santa Creu i Sant Pau, Barcelona 08025, Spain

Hospital del Mar, Barcelona, Spain

Hospital Universitario Vall d'Hebron, Barcelona 08035, 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

Haematology Research, Auckland District Health Board, Auckland City Hospital, Grafton, Auckland 1023, New Zealand

The Canberra Hospital, Garran, Australian Capital Territory 2605, Australia

Division of Hematology, Vancouver General Hospital, Vancouver, British Columbia V5Z 1M9, Canada

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, 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

CHU Lille, Service des maladies du sang, Hopital Huriez, Lille, Lille Cedex 59037, France

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

Saint John Regional Hospital, Saint John, New Brunswick E2L 4L2, Canada

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

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

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

Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia B3H 2Y9, Canada

University Hospitals fo Cleveland, Cleveland, Ohio 44106, United States

University Health Network, Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

Charles LeMoyne Hospital, Greenfield Park, Quebec J4V 2H1, Canada

Royal Brisbane and Women's Hospital, Herston, 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

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie, Praha, Srobarova 100 34 Praha 10, Czech Republic

Family Cancer Center, Memphis, Tennessee 38119, United States

Henry-Joyce Cancer Clinic, Nashville, Tennessee 37232, United States

Tennessee Oncology, PLLC, Nashville, Tennessee 37203, 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

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

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

Royal Perth Hospital, Perth, Western Australia 6000, Australia

Additional Information

Starting date: October 2010
Last updated: October 10, 2013

Page last updated: August 20, 2015

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