Acute Myeloid LeukemiaPhase 3VALORNCT01191801
Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
A Phase 3 study testing vosaroxin + cytarabine in people with Acute Myeloid Leukemia, run by Sunesis Pharmaceuticals at 124 sites in 15 countries.
Trial summary
This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- vosaroxin + cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 711 participants
- Where
- 124 sitesin 15 countries
- Study dates
- 17 Dec 2010to 1 Mar 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
124 sites in 15 countries.
124 sites in 15 countries
United States38 sites
University of Michigan
Ann Arbor, Michigan, 48109
Georgia Health Sciences University
Augusta, Georgia, 30912
Medical University of South Carolina
Charleston, South Carolina, 29425
Mecklenburg Medical Group
Charlotte, North Carolina, 28204
Rush University Medical Center, Division of Hematology/Oncology
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
University Hospitals fo Cleveland
Cleveland, Ohio, 44106
Ellis Fischel Cancer Center, University of Missouri Health Care
Columbia, Missouri, 65203
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, 80218
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia
Houston, Texas, 77030
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, 46237
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Baptist Cancer Institute
Jacksonville, Florida, 32207
Moores UCSD Cancer Center
La Jolla, California, 92093
North Shore Long Island Jewish Health System
Lake Success, New York, 11042
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
UCLA Division of Hematology/Oncology
Los Angeles, California, 90095
Family Cancer Center
Memphis, Tennessee, 38119
Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University
Morgantown, West Virginia, 26506
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Memorial Sloan-Kettering Cancer Center
New York, New York, 100065
Weill Cornell Medical College
New York, New York, 10065
Cancer Care Centers of South Texas
San Antonio, Texas, 78229
Sharp Clinical Oncology Research
San Diego, California, 92123
University of California San Francisco
San Francisco, California, 94143
Stony Brook University Medical Center
Stony Brook, New York, 11794
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
New York Medical College, Division of Oncology/Hematology
Valhalla, New York, 10595
George Washington University-Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Australia11 sites
Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, 5042
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Concord Repatriation General Hospital
Concord, New South Wales, 2139
The Canberra Hospital
Garran, Australian Capital Territory, 2605
Andrew Love Cancer Center, Geelong Hospital, Barwon Health
Geelong, Victoria, 3220
Haematology Department, Gosford Hospital
Gosford, New South Wales, 2250
The Alfred Hospital
Melbourne, Victoria, 3004
Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal Perth Hospital
Perth, Western Australia, 6000
Westmead Hospital
Westmead, New South Wales, 2145
France9 sites
CHU Angers, Service des maladies du sang
Angers, 49033
Hopital Avicenne- Departement Onco-hematologie
Bobigny, 93000
Hopital Mignot
Le Chesnay, 78157
CHU Lille, Service des maladies du sang, Hopital Huriez
Lille, Lille Cedex, 59037
Institut Paoli Calmettes
Marseille, 13009
CHU Nantes Hotel Dieu, Service d'hematologie clinique
Nantes, 44093
CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle
Pessac, 33604
Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet
Pierre-Bénite, 69495
Service d'hematologie- Hopital Purpan- CHU de Toulouse
Toulouse, 31059
Germany9 sites
St. Johannes-Hospital
Duisburg, 47166
Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt
Frankfurt, 65929
Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation
Hamburg, 20246
Medizinische Hochschule Hannover, Abteilung Hamatologie
Hanover, 30625
SLK-Kliniken Heilbronn GmbH, Medizinische Klinik
Heilbronn, 74078
Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik
Kiel, 24116
Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie
Leipzig, 04129
Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik
Munich, 81675
University Hospital of Muenster
Münster, 48149
Spain9 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
Hospital del Mar
Barcelona
Centro Oncologico MD Anderson International Espana
Madrid, 28033
Hospital Universitario La Paz
Madrid, 28046
Hospital Sont Llatzer
Palma de Mallorca, 07198
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitari Politecnic la Fe Hematology Department
Valencia, 46026
United Kingdom8 sites
Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, FY3 8NR
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, CB2 0QQ
Department of Haematology, University Hospital of Wales
Cardiff, CF14 4XW
Queen's Centre for Oncology and Hematology, Castle Hill Hospital
Cottingham, GY16 5JQ
Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust
Leicester, LE1 5WW
Department of Haematology, Royal Liverpool University Hospital
Liverpool, L7 8XP
Department of Haematology, Guy's Hospital
London, SE1 9RT
Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary
Manchester, M13 9WL
Italy7 sites
Ospedale "A. Perrino", U.O. Compessa di Ematologia
Brindisi, 72100
Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate
Ferrara, 44121
Ospedaliera Universitaria San Martino di Genova
Genova, 16132
Ospedale "Vito Fazzi", U.O Ematologia
Lecce, 73100
AORN "A. Cardarelli", U.O.S.C. Ematologia con TMO
Naples, 80131
Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia
Novara, 28100
Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia
Pavia, 27100
Belgium6 sites
ZNA Middleheim Lindendreef 1
Antwerp, 2020
ZNA Stuivenberg, Lange Beeldekensstraat 267
Antwerp
AZ St.-Jan Brugge-Oostende AV
Bruges, 8000
Cliniques Universitaires Saint Luc
Brussels, 1200
UZ Leuven, campus Gasthuisberg, Department of Haematology
Leuven, B 3000
H.-Hartziekenhuis Roeselare - Menen vzw
Roeselare, 8800
Canada5 sites
Charles LeMoyne Hospital
Greenfield Park, Quebec, J4V 2H1
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Division of Hematology, Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Austria4 sites
Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie
Graz, 8036
University Hospital for Internal Medicine V, Innsbruck Medical University
Innsbruck, 6020
Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU
Salzburg, 5020
AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1
Vienna, 1090
Hungary4 sites
University of Debrecen Medical and Health Sciences Center
Debrecen, H-4030
Petz Aladar County Hospital
Győr, H-9024
kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly
Kaposvár, H-7400
Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika
Szeged, H-6720
New Zealand4 sites
Canterbury Health Laboratories
Christchurch, 8011
Haematology Research, Auckland District Health Board, Auckland City Hospital
Grafton, Auckland, 1023
Department of Haematology, Waikato Hospital
Hamilton, 3240
Regional Cancer Treatment Service, Palmerston North Hospital
Palmerston North, 4414
South Korea4 sites
Seoul National University Hospital
Seoul, 110-744
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
Seoul St. Mary's Hospital
Seoul, 137-701
Dept. of Hematology, Asan Medical Center
Seoul, 138-736
Czechia3 sites
Fakultni nemocnice Brno, Interni hematoonkologicka klinika
Brno, 625 00
Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie
Hradec Králové, 500 05
Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie
Prague, Srobarova, 100 34 Praha 10
Poland3 sites
Uniwersyteckle Centrum Kliniczne
Gdansk, 80-952
Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-569
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, 50-369
About this study
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)
This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- vosaroxin + cytarabine, placebo + cytarabine
- Keywords
- Leukemia, Acute Myeloid Leukemia, Hematologic, Hematologic diseases, Blood, Cancer, Malignancy, Vosaroxin, Cytarabine, First Relapsed AML, Refractory AML, VALOR, Sunesis, Voreloxin, SNS-595
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Hematologic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vosaroxin + cytarabineDrug
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 + cytarabineDrug
Also called control
Placebo days 1 and 4: volume matched to vosaroxin
Cytarabine 1 g/m2 daily on days 1-5 (IDAC)
| Study group | Role | What they receive |
|---|---|---|
| Group A: vosaroxin + cytarabine | Experimental | 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 Receives: Drug: vosaroxin + cytarabine |
| Group B: placebo + cytarabine | Placebo comparator | 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 Receives: Drug: placebo + cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
Measured: Up to 5 years or duration of study
Secondary outcomes (3)
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.
Measured: Up to 5 years or duration of study
All Cause Mortality
Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality
Measured: 30 Days
All Cause Mortality
Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study start17 Dec 2010
- Primary completion26 Sep 2014
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunesis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Neuman, MD, Study director, Sunesis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191801
- Sponsor's protocol ID
- VOS-AML-301
- Other IDs
- 2010-021961-61
- Acronym
- VALOR
- Status last verified
- Mar 2017
- First submitted
- 27 Aug 2010
- Last updated
- 22 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data of individual participants experiencing Serious Adverse Events
Publications
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.
PubMed 26234174
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01191801
- Acronym / sponsor ID
- VALOR / VOS-AML-301
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Leukemia, Acute Myeloid Leukemia, Hematologic, Hematologic diseases, Blood, Cancer, Malignancy, Vosaroxin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Sunesis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2010
- Primary completion
- 26 Sep 2014 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Posted 9 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: vosaroxin + cytarabine | Experimental | Drug: vosaroxin + cytarabinevosaroxin (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 comparator | Drug: placebo + cytarabineplacebo (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vosaroxin + cytarabineVosaroxin 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) | Drug | Group A: vosaroxin + cytarabine |
| placebo + cytarabineAlso: controlPlacebo days 1 and 4: volume matched to vosaroxin Cytarabine 1 g/m2 daily on days 1-5 (IDAC) | Drug | Group B: placebo + cytarabine |
Primary outcome
Overall Survival
Time frame: Up to 5 years or duration of study
Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
3 secondary outcomes
Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.
Time frame: Up to 5 years or duration of study
All Cause Mortality
Time frame: 30 Days
All Cause Mortality
Time frame: 60 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26234174Ravandi 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.
- Individual participant dataSharing planned: Yes. De-identified data of individual participants experiencing Serious Adverse Events
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RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Neuman, MD study director
Sunesis Pharmaceuticals
124 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vosaroxin + cytarabine in people with Acute Myeloid Leukemia, run by Sunesis Pharmaceuticals at 124 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 124 sites in United States, Australia, France, Germany, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Up to 5 years or duration of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01191801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.