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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United States

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

Other trials in Australia

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

Other trials in France

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

Other trials in Germany

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

Other trials in Spain

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

Other trials in United Kingdom

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

Other trials in Italy

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

Other trials in Belgium

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

Other trials in Canada

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

Other trials in Austria

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

Other trials in Hungary

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

Other trials in New Zealand

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

Other trials in South Korea

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

Other trials in Czechia

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

Other trials in Poland

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.

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 groups in NCT01191801
Study groupRoleWhat they receive
Group A: vosaroxin + cytarabineExperimentalvosaroxin (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 + cytarabinePlacebo comparatorplacebo (short IV infusion within 10 minutes and volume matched to vosaroxin) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation
Receives: Drug: placebo + cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival

    Measured: Up to 5 years or duration of study

Secondary outcomes (3)

  1. 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

  2. All Cause Mortality

    Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality

    Measured: 30 Days

  3. 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.

  1. First posted31 Aug 2010 (estimated)
  2. Study start17 Dec 2010
  3. Primary completion26 Sep 2014
  4. Study completion1 Mar 2017

Resources

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)
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
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

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.

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