search
Back to results

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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
vosaroxin + cytarabine
placebo + cytarabine
Sponsored by
Sunesis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A: vosaroxin + cytarabine

Group B: placebo + cytarabine

Arm Description

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

Outcomes

Primary Outcome Measures

Overall Survival
Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival

Secondary Outcome Measures

Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.
Group A (Vosaroxin + cytarabine) patient CR as compared to Group B (placebo + cytarabine) patient CR. Complete remission (CR) is typically defined using IWG criteria as bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts.
All Cause Mortality
Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality
All Cause Mortality
Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality

Full Information

First Posted
August 27, 2010
Last Updated
July 25, 2018
Sponsor
Sunesis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01191801
Brief Title
Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
Acronym
VALOR
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 17, 2010 (undefined)
Primary Completion Date
September 26, 2014 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunesis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Leukemia, Acute Myeloid Leukemia, Hematologic, Hematologic diseases, Blood, Cancer, Malignancy, Vosaroxin, Cytarabine, First Relapsed AML, Refractory AML, VALOR, Sunesis, Voreloxin, SNS-595

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
711 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: vosaroxin + cytarabine
Arm Type
Experimental
Arm Description
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
Arm Title
Group B: placebo + cytarabine
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
vosaroxin + cytarabine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
placebo + cytarabine
Other Intervention Name(s)
control
Intervention Description
Placebo days 1 and 4: volume matched to vosaroxin Cytarabine 1 g/m2 daily on days 1-5 (IDAC)
Primary Outcome Measure Information:
Title
Overall Survival
Description
Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
Time Frame
Up to 5 years or duration of study
Secondary Outcome Measure Information:
Title
Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.
Description
Group A (Vosaroxin + cytarabine) patient CR as compared to Group B (placebo + cytarabine) patient CR. Complete remission (CR) is typically defined using IWG criteria as bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts.
Time Frame
Up to 5 years or duration of study
Title
All Cause Mortality
Description
Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality
Time Frame
30 Days
Title
All Cause Mortality
Description
Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality
Time Frame
60 Days
Other Pre-specified Outcome Measures:
Title
Overall Remission (OR) Rate Based on the IWG Response Criteria
Description
Group A patient OR compared to Group B patient OR Overall Remission includes Complete Remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with incomplete blood count recovery (CRi), and Partial Remission (PR). Complete remission means bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts as typically defined by the IWG. Both CRi and CRp refer complete remission but with incomplete blood count and platelet recovery, respectively. PR, or partial remission, refers to remission in which bone marrow contains blast counts between 5 and 25 percent.
Time Frame
Up to 5 years or the duration of the study
Title
Event Free Survival (EFS)
Time Frame
Up to 5 years or duration of study
Title
Leukemia-Free Survival (LFS)
Description
Durability of remission (CR) assessed by LFS
Time Frame
Up to 5 years or the duration of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Neuman, MD
Organizational Affiliation
Sunesis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA Division of Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
George Washington University-Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Georgia Health Sciences University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Rush University Medical Center, Division of Hematology/Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Francis Medical Group Oncology and Hematology Specialists
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Ellis Fischel Cancer Center, University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
North Shore Long Island Jewish Health System
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
100065
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
New York Medical College, Division of Oncology/Hematology
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Mecklenburg Medical Group
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals fo Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Family Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Henry-Joyce Cancer Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Haematology Department, Gosford Hospital
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Andrew Love Cancer Center, Geelong Hospital, Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
University Hospital for Internal Medicine V, Innsbruck Medical University
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
ZNA Middleheim Lindendreef 1
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
ZNA Stuivenberg, Lange Beeldekensstraat 267
City
Antwerpen
Country
Belgium
Facility Name
AZ St.-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven, campus Gasthuisberg, Department of Haematology
City
Leuven
ZIP/Postal Code
B 3000
Country
Belgium
Facility Name
H.-Hartziekenhuis Roeselare - Menen vzw
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Division of Hematology, Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Charles LeMoyne Hospital
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie
City
Praha
State/Province
Srobarova
ZIP/Postal Code
100 34 Praha 10
Country
Czechia
Facility Name
Fakultni nemocnice Brno, Interni hematoonkologicka klinika
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
CHU Lille, Service des maladies du sang, Hopital Huriez
City
Lille
State/Province
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Angers, Service des maladies du sang
City
Angers Cedex 01
ZIP/Postal Code
49033
Country
France
Facility Name
Hopital Avicenne- Departement Onco-hematologie
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hopital Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CHU Nantes Hotel Dieu, Service d'hematologie clinique
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Service d'hematologie- Hopital Purpan- CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
St. Johannes-Hospital
City
Duisburg
ZIP/Postal Code
47166
Country
Germany
Facility Name
Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Abteilung Hamatologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
SLK-Kliniken Heilbronn GmbH, Medizinische Klinik
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
University Hospital of Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
University of Debrecen Medical and Health Sciences Center
City
Debrecen
ZIP/Postal Code
H-4030
Country
Hungary
Facility Name
Petz Aladar County Hospital
City
Gyor
ZIP/Postal Code
H-9024
Country
Hungary
Facility Name
kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly
City
Kaposvar
ZIP/Postal Code
H-7400
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Ospedale "A. Perrino", U.O. Compessa di Ematologia
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate
City
Ferrara
ZIP/Postal Code
44121
Country
Italy
Facility Name
Ospedaliera Universitaria San Martino di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale "Vito Fazzi", U.O Ematologia
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
AORN "A. Cardarelli", U.O.S.C. Ematologia con TMO
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Dept. of Hematology, Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Haematology Research, Auckland District Health Board, Auckland City Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Canterbury Health Laboratories
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Department of Haematology, Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Regional Cancer Treatment Service, Palmerston North Hospital
City
Palmerston North
ZIP/Postal Code
4414
Country
New Zealand
Facility Name
Uniwersyteckle Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-369
Country
Poland
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Centro Oncologico MD Anderson International Espana
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Sont Llatzer
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitari Politecnic la Fe Hematology Department
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Department of Haematology, University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Queen's Centre for Oncology and Hematology, Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
GY16 5JQ
Country
United Kingdom
Facility Name
Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Department of Haematology, Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Department of Haematology, Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data of individual participants experiencing Serious Adverse Events
Citations:
PubMed Identifier
26234174
Citation
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.
Results Reference
derived

Learn more about this trial

Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML

We'll reach out to this number within 24 hrs