Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML (VALOR)
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Leukemia, Acute Myeloid Leukemia, Hematologic, Hematologic diseases, Blood, Cancer, Malignancy, Vosaroxin, Cytarabine, First Relapsed AML, Refractory AML, VALOR, Sunesis, Voreloxin, SNS-595
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Had known HIV seropositivity
Sites / Locations
- Moores UCSD Cancer Center
- UCLA Division of Hematology/Oncology
- Sharp Clinical Oncology Research
- University of California San Francisco
- HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program
- George Washington University-Medical Faculty Associates
- Holy Cross Hospital
- Baptist Cancer Institute
- H. Lee Moffitt Cancer Center & Research Institute
- Georgia Health Sciences University
- Rush University Medical Center, Division of Hematology/Oncology
- University of Chicago
- Indiana University Melvin and Bren Simon Cancer Center
- St. Francis Medical Group Oncology and Hematology Specialists
- University of Iowa Hospitals and Clinics
- Ochsner Clinic Foundation
- University of Michigan
- Henry Ford Health System
- Ellis Fischel Cancer Center, University of Missouri Health Care
- Dartmouth-Hitchcock Medical Center
- John Theurer Cancer Center at Hackensack University Medical Center
- North Shore Long Island Jewish Health System
- Memorial Sloan-Kettering Cancer Center
- Weill Cornell Medical College
- Stony Brook University Medical Center
- New York Medical College, Division of Oncology/Hematology
- Mecklenburg Medical Group
- Duke University Medical Center
- Wake Forest University Health Sciences
- University Hospitals fo Cleveland
- Medical University of South Carolina
- Family Cancer Center
- Tennessee Oncology, PLLC
- Henry-Joyce Cancer Clinic
- UT Southwestern Medical Center at Dallas
- The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia
- Cancer Care Centers of South Texas
- Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University
- The Canberra Hospital
- Concord Repatriation General Hospital
- Haematology Department, Gosford Hospital
- Westmead Hospital
- Royal Brisbane and Women's Hospital
- Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital
- Flinders Medical Centre
- Andrew Love Cancer Center, Geelong Hospital, Barwon Health
- The Alfred Hospital
- Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital
- Royal Perth Hospital
- Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie
- University Hospital for Internal Medicine V, Innsbruck Medical University
- Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU
- AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1
- ZNA Middleheim Lindendreef 1
- ZNA Stuivenberg, Lange Beeldekensstraat 267
- AZ St.-Jan Brugge-Oostende AV
- Cliniques Universitaires Saint Luc
- UZ Leuven, campus Gasthuisberg, Department of Haematology
- H.-Hartziekenhuis Roeselare - Menen vzw
- Division of Hematology, Vancouver General Hospital
- Saint John Regional Hospital
- Queen Elizabeth II Health Sciences Centre
- University Health Network, Princess Margaret Hospital
- Charles LeMoyne Hospital
- Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie
- Fakultni nemocnice Brno, Interni hematoonkologicka klinika
- Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie
- CHU Lille, Service des maladies du sang, Hopital Huriez
- CHU Angers, Service des maladies du sang
- Hopital Avicenne- Departement Onco-hematologie
- Hopital Mignot
- Institut Paoli Calmettes
- CHU Nantes Hotel Dieu, Service d'hematologie clinique
- CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle
- Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet
- Service d'hematologie- Hopital Purpan- CHU de Toulouse
- St. Johannes-Hospital
- Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt
- Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation
- Medizinische Hochschule Hannover, Abteilung Hamatologie
- SLK-Kliniken Heilbronn GmbH, Medizinische Klinik
- Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik
- Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie
- University Hospital of Muenster
- Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik
- University of Debrecen Medical and Health Sciences Center
- Petz Aladar County Hospital
- kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly
- Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika
- Ospedale "A. Perrino", U.O. Compessa di Ematologia
- Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate
- Ospedaliera Universitaria San Martino di Genova
- Ospedale "Vito Fazzi", U.O Ematologia
- AORN "A. Cardarelli", U.O.S.C. Ematologia con TMO
- Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia
- Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia
- Seoul National University Hospital
- Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
- Seoul St. Mary's Hospital
- Dept. of Hematology, Asan Medical Center
- Haematology Research, Auckland District Health Board, Auckland City Hospital
- Canterbury Health Laboratories
- Department of Haematology, Waikato Hospital
- Regional Cancer Treatment Service, Palmerston North Hospital
- Uniwersyteckle Centrum Kliniczne
- Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
- Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario Vall d'Hebron
- Hospital Universitari Germans Trias i Pujol
- Hospital del Mar
- Centro Oncologico MD Anderson International Espana
- Hospital Universitario La Paz
- Hospital Sont Llatzer
- Hospital Universitario de Salamanca
- Hospital Universitari Politecnic la Fe Hematology Department
- Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust
- Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
- Department of Haematology, University Hospital of Wales
- Queen's Centre for Oncology and Hematology, Castle Hill Hospital
- Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust
- Department of Haematology, Royal Liverpool University Hospital
- Department of Haematology, Guy's Hospital
- Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Group A: vosaroxin + cytarabine
Group B: placebo + cytarabine
vosaroxin (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
placebo (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