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AMLPhase 3NCT02039726

(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

A Phase 3 study testing Quizartinib and Salvage Chemotherapy in people with AML, run by Daiichi Sankyo at 131 sites in 19 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

The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AML
What is being tested?
Quizartinib and Salvage Chemotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
367 participants
Where
131 sitesin 19 countries
Study dates
May 2014to 8 Sep 2020
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

  • Provision of written informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) with privacy language in accordance with national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for United States [US] sites) prior to any study related procedures, including withdrawal of prohibited medications if applicable.
  • Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of Informed consent.
  • Morphologically documented primary Acute Myeloid Leukemia (AML) or AML secondary to Myelodysplastic Syndrome (MDS), as defined by World Health Organization (WHO) criteria, as determined by pathology review at the study site.
  • In first relapse (with duration of remission of 6 months or less) or refractory after prior therapy, with or without HSCT. Induction therapy must have included at least 1 cycle of an anthracycline/mitoxantrone-containing induction block at a standard dose.
  • Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood (allelic ratio as determined by a central laboratory with a cutoff of ≥3% FLT3-ITD/total FLT3). If a specimen has been sent for FLT3-ITD testing at the central laboratory but the subject requires treatment for AML before the central FLT3-ITD test result is available, a local test result may be acceptable for randomization after consultation with the Medical Monitor.
  • Eligibility for pre-selected salvage chemotherapy, according to the Investigator's assessment.
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  • Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
  • Discontinuation of prior AML treatment before the start of study treatment (except hydroxyurea or other treatment to control leukocytosis) for at least 2 weeks for cytotoxic agents, or for at least 5 half-lives for non cytotoxic agents.
  • Serum creatinine ≤1.5×upper limit of normal (ULN), or glomerular filtration rate >25 mL/min, as calculated with the Cockcroft-Gault formula.
  • Serum potassium, magnesium, and calcium (serum calcium corrected for hypoalbuminemia) within institutional normal limits. Subjects with electrolytes outside the normal range will be eligible if these values are corrected upon retesting following any necessary supplementation.
  • Total serum bilirubin ≤1.5×ULN.
  • Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5×ULN.

Who cannot join

  • Acute Promyelocytic Leukemia (AML subtype M3).
  • AML secondary to prior chemotherapy for other neoplasms, except AML secondary to prior Myelodysplastic Syndrome (MDS).
  • History of another malignancy, unless the candidate has been disease-free for at least 5 years.
  • Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy.
  • Clinically significant graft versus host disease (GVHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or > Grade 1 persistent or clinically significant non hematologic toxicity related to HSCT.
  • History of or current, central nervous system involvement with AML.
Show all 21Show fewer
  • Clinically significant coagulation abnormality, such as disseminated intravascular coagulation.
  • Prior treatment with quizartinib or participated in a prior quizartinib study.
  • Prior treatment with a FLT3 targeted therapy including sorafenib or investigational FLT3 inhibitors (not including the multi-kinase inhibitor, midostaurin).
  • Major surgery within 4 weeks prior to screening.
  • Radiation therapy within 4 weeks prior to screening.
  • Uncontrolled or significant cardiovascular disease
  • Active infection not well controlled by antibacterial or antiviral therapy.
  • Known infection with human immunodeficiency virus, or active hepatitis B or C, or other active clinically relevant liver disease.
  • Unwillingness to receive infusion of blood products according to the protocol.
  • In a man whose sexual partner is a woman of childbearing potential, unwillingness or inability of the man or woman to use a highly effective contraceptive method for the entire study treatment period for at least 3 months after study completion. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and 105 days after the final study drug administration.
  • In a heterosexually active woman of childbearing potential, unwillingness or inability to use a highly effective contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion. Additionally, for women randomized to chemotherapy, unwillingness to adhere to the restrictions in the respective locally established guidelines and local approved label (prescribing information, Summary of Product Characteristics, or US product insert) from the manufacturer and the Patient Information Leaflet (package insert) as instructed by the Investigator.
  • Pregnancy.
  • Female Subjects must agree to not breastfeed from the time of Screening and throughout the study period, and for 25 days after the final study drug administration.
  • Medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.
  • For subjects in the United Kingdom only: Refusal of permission to allow the subject's General Practitioner to be notified of their participation in the study.

Trial locations and contacts

131 sites in 19 countries.

131 sites in 19 countries

United States36 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • UNC Linebreger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • University of Illinois at Chicago

    Chicago, Illinois, 60607

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke Cancer Institute at Duke University Health System

    Durham, North Carolina, 27710

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • MD Anderson Center, The University of Texas

    Houston, Texas, 77030

  • Franciscan Alliance

    Indianapolis, Indiana, 46237

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06520

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Oregon Health and Science University Knight Cancer Institute

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • UC Davis Cancer Center

    Sacramento, California, 95817

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • LSU Health Sciences Center Feist Weiller Cancer Center

    Shreveport, Louisiana, 71103

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center Stanford Comprehensive Cancer Center

    Stanford, California, 94305

  • NY Medical College

    Valhalla, New York, 10595

  • University of Kansas Medical Center Research Institute Inc

    Westwood, Kansas, 66205

  • Wake Forest University Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany14 sites

  • Charité Universitätsmedizin Berlin

    Berlin, 12200

  • Charité Campus Virchow Klinikum

    Berlin, 13353

  • Klinikum Braunschweig

    Braunschweig, 38114

  • Universitatsklinikum Dresden

    Dresden, 01307

  • Klinikum der Johann Wolfgang-Goethe-Universität

    Frankfurt, 60590

  • Universitätsklinikum Halle

    Halle, 06120

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Uniklinik Heidelberg Medizinische Klinik und Poliklinik V

    Heidelberg, 69120

  • Universitätsklinikum Jena

    Jena, 07743

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • University Mainz

    Mainz, 55131

  • Universitätsklinikum Giessen und Marburg GmbH

    Marburg, 35043

  • LMU München Klinikum Großhadern

    München, 81377

  • Medizinische Klinik A Hämatologie Hämostaseologie Internistische Onkologie und Pneumologie

    Münster, 48149

Other trials in Germany

Italy14 sites

  • AOU Policlinico Consorziale di Bari

    Bari, 70124

  • Università di Bologna

    Bologna, 40138

  • Unità Operativa di Ematologia e Unità Operativa CTMO

    Cagliari

  • Arcispedale S Anna

    Ferrara, 44124

  • AOU Careggi

    Florence, 50134

  • IRCCS Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • Opsedale San Martino di Genova

    Genova, 16132

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Azienda Ospedaliero Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • L'UOC di Ematologia del Policlinico Tor Vergata

    Rome, 00133

  • Policlinico Universitario Agostino Gemelli

    Rome, 00168

  • Azienda Ospedaliero Universitaria Senese, Policlinico S. Maria alle Scotte

    Siena, 53100

  • Ospedale di Circolo-a Fondazione Macchi

    Varese, 21100

Other trials in Italy

France10 sites

  • CHU de Caen

    Caen, 14000

  • Centre Hospitalier Universitaire Grenoble Hopital Michalon

    Grenoble, 38043

  • Centre Hospitalier de Versailles

    Le Chesnay, 78157

  • Hopital de la Conception

    Marseille, 13385

  • Centre Hospitalier Universitaire Nantes

    Nantes, 44035

  • Hôpital Saint Louis

    Paris, 75010

  • Hopital Saint-Antoine

    Paris, 75571

  • Hopital Haut Leveque Centre Francois Magendie

    Pessac, 33604

  • Centre Henri-Becquerel

    Rouen, 76038

  • Centre Hospitalier Universitaire Purpan

    Toulouse, 31059

Other trials in France

Spain8 sites

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Son Espases

    Palma, De Mallorca, 07120

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital La Fe

    Valencia, SP, 46026

Other trials in Spain

United Kingdom7 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • University Hospital of Wales

    Cardiff, South Glamorgan, CF14 4XW

  • Saint James University Hospital

    Leeds, England, LS9 7TF

  • King's College Hospital

    London, England, SE5 9RS

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG51PB

  • Royal Marsden Hospital Sutton

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • The Princess Alexandra Hospital

    Brisbane, Queensland

  • The Canbera Hospital

    Garran, New South Wales, 2605

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

South Korea6 sites

  • Kyungpook National University Hospital

    Daegu, 700-721

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

  • Samsung Medical Center

    Seoul, 135-710

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 137-701

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Taiwan4 sites

  • China Medical University Hospital

    Taichung, 404

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Belgium3 sites

  • ZNA Stuivenberg

    Antwerp, BE, 2060

  • UCL St Luc

    Brussels, BE, 1200

  • Leuven UZ Gasthuisberg

    Leuven, BE, 3000

Other trials in Belgium

Canada3 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Princess Margaret Cancer Centre Princess Margaret Hospital

    Toronto, Ontario, M5G2M9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Czechia3 sites

  • Fakultni nemocnice Brno

    Brno, 62500

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Fakultni nemocnice Olomouc

    Olomouc, 77900

Other trials in Czechia

Hungary3 sites

  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar I. Belgyogyaszati Klinika

    Budapest, Pest County, 1083

  • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet

    Debrecen, Hajdú-Bihar, 4032

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent Gyorgyi Albert Klinikai Kozpont

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Netherlands3 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Erasmus Medical Center

    Rotterdam, 3015 CE

Other trials in Netherlands

Poland3 sites

  • Uniwersytecki Szpital Kliniczny w Biatymstoku, Klinika Hematologii z Pododzialem Chorob Naczyn

    Bialystok, 15276

  • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach Oddzial Hematologii i Transplantacji Szpiku

    Katowice, 40032

  • Samodzielny Publiczny Szpital Kliniczny Nr 1, Klinika Hematoonkologii i Transplantacji Szpiku

    Lublin, 20081

Other trials in Poland

Croatia2 sites

  • Klinička Bolinca Merkur

    Zagreb, 10000

  • Kliničko Bolnički Centar Zagreb

    Zagreb, 10000

Other trials in Croatia

Hong Kong2 sites

  • The Chinese University of Hong Kong, Prince of Wales Hospital

    Hong Kong

  • The University of Hong Kong, Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Serbia2 sites

  • Klinicki Centar Srbije

    Belgrade, 11000

  • Klinicki Centar Vojvodine

    Novi Sad, 21000

Other trials in Serbia

Singapore2 sites

  • National University of Singapore

    Singapore, 119228

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

About this study

Official title: A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.

Conditions
AML
Being tested
Quizartinib, Salvage Chemotherapy
Keywords
Acute Myeloid Leukemia, AML, FMS-like tyrosine kinase 3, FLT3-ITD, Quizartinib, Leukemia, Tablets
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuizartinibDrug

    Also called AC220

    20 or 30 mg quizartinib tablets administered orally once daily

  • Salvage ChemotherapyDrug

    Also called Standard of Care

    Low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA) administered during 28-day cycles

Study groups in NCT02039726
Study groupRoleWhat they receive
QuizartinibExperimentalParticipants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily.
Receives: Drug: Quizartinib
Salvage chemotherapyActive comparatorParticipants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
Receives: Drug: Salvage Chemotherapy

What is being measured

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

  1. Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy

    Overall Survival is defined as the time (in weeks) from the date of randomization to the date of death due to any cause. Median and quartiles are calculated using the Kaplan-Meier method.

    Measured: At approximately 3 years 9 months

Secondary outcomes (1)

  1. Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy

    Event-free survival is defined as the time (in weeks) from randomization until documented refractory disease, relapse after complete composite remission (CRc), or death from any cause, whichever is observed first.

    Measured: At approximately 3 years 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2014 (estimated)
  2. Study startMay 2014
  3. Primary completion22 Feb 2018
  4. Study completion8 Sep 2020

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
None (open label)
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02039726
Sponsor's protocol ID
AC220-007
Other IDs
EudraCT Number 2013-004890-28
Status last verified
Feb 2021
First submitted
15 Jan 2014
Last updated
24 Feb 2021
Data monitoring committee
Yes
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Kang D, Ludwig E, Jaworowicz D, Huang H, Fiedler-Kelly J, Cortes J, Ganguly S, Khaled S, Kramer A, Levis M, Martinelli G, Perl A, Russell N, Abutarif M, Choi Y, Yin O. Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia. Cancer Chemother Pharmacol. 2021 Apr;87(4):513-523. doi: 10.1007/s00280-020-04204-y. Epub 2021 Jan 8.

    PubMed 33415416

  • Cortes JE, Khaled S, Martinelli G, Perl AE, Ganguly S, Russell N, Kramer A, Dombret H, Hogge D, Jonas BA, Leung AY, Mehta P, Montesinos P, Radsak M, Sica S, Arunachalam M, Holmes M, Kobayashi K, Namuyinga R, Ge N, Yver A, Zhang Y, Levis MJ. Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):984-997. doi: 10.1016/S1470-2045(19)30150-0. Epub 2019 Jun 4.

    PubMed 31175001

  • Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

    PubMed 29859851

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quizartinib and Salvage Chemotherapy in people with AML, run by Daiichi Sankyo at 131 sites in 19 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 12 inclusion and 21 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, Germany, Italy, France, Spain and 14 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. 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 27 Jan 2020). 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 in Participants That Received Quizartinib Versus Salvage Chemotherapy (time frame: At approximately 3 years 9 months). 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 NCT02039726, which also lists 3 linked publications.

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 24 Feb 2021.

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