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LymphomaPhase 3REMARCNCT01122472

Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP

A Phase 3 study testing Lenalidomide in people with Lymphoma and Diffuse Large B-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 157 sites in 9 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 is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy For the primary efficacy variable, PFS, an… Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Lymphoma, Diffuse Large B-cell Lymphoma
What is being tested?
Lenalidomide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
650 participants
Where
157 sitesin 9 countries
Study dates
Apr 2009to Sep 2019
Phase
Phase 3
Are there results?
None posted in the registry

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 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For patients registered at the time of initial diagnosis
  • Patient with histologically proven CD20+ diffuse large B cel LYMPHOMA (DLBCL) 5WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B Or CD20+ Aggressive B-cell lymphoma unclassifiable
  • previous untreated with chemo- or radiotherapy
  • For patients registered after response evaluation to first line treatment with R-CHOP:
  • Patient with histologically proven CD20+ diffuse large B cell LYMPHOMA (DLBCL) 5WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B Or CD20+ Aggressive B-cell lymphoma unclassifiable
  • Have reached a CR or PR after first line treatment with at least 6 cycles of R-CHOP 14 regimens and up to 8 cycles of R-CHOP21
Show all 19Show fewer
  • Previously untreated with Radiotherapy
  • For all patients:
  • aged from 60 to 80 years at time of registration
  • Ann Arbor stages II-IV at time of initial diagnosis
  • aaIPI> 1 at time of initial diagnosis
  • ECOG performance status 0-2
  • Minimum life expectancy of 3 months
  • Following laboratory values at screening:
  • ANC≥ 1000.10^6/L and Platelets≥60000.10^6/L
  • AST<5*ULN, ALT<5*ULN, Total Bilirubin<1,5*ULN
  • Creatinine clearance>30mL/min
  • Women are are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and after end of study. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
  • Having previously signed a written informed consent form

Who cannot join

  • Any other histological type of Lymphoma, Burkitt included.
  • Any history of treated or non treated small B-cell lymphoma
  • Central nervous system or meningeal involvement by lymphoma
  • Contraindication to any drug contained in the chemotherapy regimen Myocardial infarction during last 3 months or unstable coronary disease or uncontrolled chronic symptomatic congestive heart insufficiency NYHA III-IV
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus as defined by the investigator
Show all 11Show fewer
  • Active systemic infection requiring treatment
  • previously known HIV positive serology
  • Active hepatitis B or C
  • Prior history of malignancies other than lymphoma within 3 years
  • Serious medical or psychiatric illness

Trial locations and contacts

157 sites in 9 countries.

157 sites in 9 countries

France73 sites

  • CHR de la Région d'Annecy

    Annecy, 74011

  • CH Antibes-Juan les Pins

    Antibes, 06606

  • CH d'Arras

    Arras, 62022

  • Hopital Henri DUFFAUT

    Avignon, 84902

  • Hopital de BAYONNE

    Bayonne, 64100

  • CHG Mail Pierre Charlot

    Blois, 41016

  • Hôpital d'Avicenne

    Bobigny, 93009

  • Hopital Jean VERDIER

    Bondy, 93143

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Hopital DUCHENNE

    Boulogne-sur-Mer, 62200

  • CH de Bourg-en-Bresse

    Bourg-en-Bresse, 01012

  • Centre Hospitalier de Brive

    Brive-la-Gaillarde, 19100

  • Centre François Baclesse

    Caen, 14026

  • CHU Clémenceau- Côte de Nacre

    Caen, 14033

  • CH de Cannes

    Cannes, 06400

  • Hôpital de Châlon

    Chalon-sur-Saône, 711100

  • Centre Hospitalier

    Chambéry, 73011

  • CH Chartres

    Chartres, 28018 BP407

  • Hopital Antoine Béclère

    Clamart, 92140

  • Hôpital des instructions des Armées PERCY

    Clamart, 92140

  • Hopital Louis Pasteur

    Colmar, 68024

  • CH de Compiègne

    Compiègne, 60321

  • Hopital Sud Francilien

    Corbeil-Essonnes, 91108

  • CH Henri Mondor

    Créteil, 94010

  • CHU le Bocage

    Dijon, 21034

  • CH de Dunkerque

    Dunkirk, 59385

  • CHI Evreux

    Évreux, 27000

  • CHI Fréjus Saint Raphaêl

    Fréjus, 83608

  • Institut Daniel Hollard

    Grenoble, 38028

  • Centre Hospitalier de Guéret

    Guéret, 23000

  • CHG La Rochelle

    La Rochelle, 17019

  • Hopital André Mignot

    Le Chesnay, 78150

  • Hopital Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72015

  • CHU de Lens

    Lens, 62307

  • Hôpital Saint Vincent de Paul

    Lille, 59020

  • CHRU de Lille

    Lille, 59037

  • Hopital DUPUYTREN

    Limoges, 87042

  • Clinique de la Sauvegarde

    Lyon, 69337

  • Centre Léon Bérard

    Lyon, 69373

  • CH les CHANAUX

    Mâcon, 71018

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hopital Nord

    Marseille, 13915

  • CHG Meaux

    Meaux, 77100

  • CH Marc JACQUET

    Melun, 77011

  • Hopital Notre Dame de Bon Secours

    Metz, 57038

  • CRLC Val d'Aurelle

    Montpellier, 34298

  • Centre Azuréen de Cancérologie

    Mougins, 062250

  • Hopital Emile Muller- CHU Mulhouse

    Mulhouse, 68070

  • Hôpital Américain de Paris

    Neuilly-sur-Seine, 92202

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU de Nice

    Nice, 06202

  • Hopital Saint Antoine

    Paris, 75012

  • Hôtel Dieu

    Paris, 75181

  • Institut Curie

    Paris, 75248

  • Hopital St-Louis

    Paris, 75475

  • Hopital de la Pitié Salpetrière

    Paris, 75651

  • Hopital NECKER

    Paris, 75743

  • CH de Perpignan

    Perpignan, 66046

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 64495

  • CH René DUBOS

    Pontoise, 95303

  • Hopital Robert DEBRE

    Reims, 51092

  • Centre Henri BECQUEREL

    Rouen, 76038

  • Clinique Mathilde

    Rouen, 76175

  • Centre René Huguenin

    Saint-Cloud, 92211

  • CHG Saint Germain

    Saint-Germain-en-Laye, 78105

  • CHI Toulon La Seyne-sur-mer

    Toulon, 83056

  • CHU Purpan Pav. Dieulafoy

    Toulouse, 31059

  • Hopital de Troyes

    Troyes, 10000

  • CH Valence

    Valence, 26953

  • CH de Valenciennes

    Valenciennes, 59322

  • CHU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave ROUSSY

    Villejuif, 94805

Other trials in France

Belgium26 sites

  • ZNA Middelheim

    Antwerp, 2020

  • ZNA Stuivenberg

    Antwerp, 2060

  • Hopital Saint Joseph

    Arlon, 6700

  • A.Z. Sint Jan AV

    Bruges, 8000

  • CHU Brugmann

    Brussels, 1020

  • Institut Jules BORDET

    Brussels

  • Universite Catholique de Louvain Saint Luc

    Brussels

  • CH Notre Dame

    Charleroi, 6000

  • CHU Charleroi-Vesale

    Charleroi, B-6000

  • Centre de Sante des Fagnes

    Chimay, 6460

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Clinique Notre Dame de Grace

    Gosselies, 6041

  • Hopital Jolimont

    Haine-Saint-Paul, 7100

  • CH Hutois

    Huy, 4500

  • AZ VUB

    Jette, 1090

  • AZ Groeninge - Campus Maria s Voorzienigheid

    Kortrijk, 8500

  • CHR de la Citadelle

    Liège, 4000

  • CHU de Liege

    Liège, 4000

  • CHU Ambroise Pare

    Mons, 7000

  • Clinique Saint Joseph

    Mons, 7000

  • Hopital Sainte Elisabeth

    Namur, 5000

  • Clinique Saint Pierre

    Ottignies, 1340

  • Heilig Hart Ziekenhuis

    Roeselare, 8800

  • CH de la Tourelle-Peltzer

    Verviers, 4800

  • A.Z. Sint-Augustinus

    Wilrijk, 2610

  • Universite Catholique de Louvain Mont Godinne

    Yvoir, 5530

Other trials in Belgium

Spain16 sites

  • Complejo Hospitalario Universitario de A Coruna

    A Coruña, 15006

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, 28922

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hopital Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hopital de Jerez (S.A.S)

    Jerez de la Frontera, 11407

  • Hospital de Leon

    León, 24080

  • Hospital 12 de Octubre

    Madrid, 28003

  • Hospital Général Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario - La Paz

    Madrid, 28046

  • Hospital Morales Meseguer

    Murcia, 30008

  • Hospital Central Asturias

    Oviedo, 33006

  • Hospital Clinico Salamanca

    Salamanca, 37007

  • Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Joan XXIII

    Tarragona, 43007

  • Hospital Mutua de Terrassa

    Terrassa, 08221

Other trials in Spain

Australia15 sites

  • Bendigo Hospital

    Bendigo, 3550

  • Concord Repatriation General Hospital

    Concord, 2139

  • Flinders Medical Centre - Repatriation General Hospital

    Daw Park, 5000

  • St Vincent's Hospital, Melbourne

    Fitzroy, 3065

  • Frankston Hospital Monash Medical Centre

    Frankston, 3199

  • Fremantle Hospital

    Fremantle, 6160

  • Canberra Hospital

    Garran, 2606

  • Austin Hospital

    Heidelberg, 69126

  • Royal Hobart Hospital

    Hobart, 7000

  • Mater Misericordiae Hospital - Calvary Mater NewCastle

    Hunter, 2310

  • St George Hospital

    Kogarah, 2217

  • Sir Charles Gardiner Hospital

    Nedlands, 6009

  • Gold Coast Hospital

    Southport, 4215

  • Albury Base Hospital/Murray Valley Private Hospital

    Wodonga, 3690

  • Queen Elizabeth Hospital

    Woodville, 5011

Other trials in Australia

Austria10 sites

  • LKH Feldkirch

    Feldkirch, 6807

  • Medizinische Universität Innsbruck für Innere Medizin

    Innsbruck, 6020

  • LKH Leoben-Eisenerz Department für Hämato-Onkologie

    Leoben, 8700

  • Krankenhaus Barmherzigen Schwestern Linz - Abteilung für Inner

    Linz, 4010

  • Krankenhaus der Elisabethinen Linz GmbH

    Linz, 4010

  • AKh Linz - Innere Medizin 3 - Zentrum für Hämatologie un

    Linz, 4021

  • Universitätklinik der PMU Salzburg - Für Innere Medizin III

    Salzburg, 5020

  • Landeskrankenhaus Steyr - Innere Medizin II

    Steyr, 4400

  • Uniersitätsklinik f. Innere Medizin I

    Vienna, A-1090 VIE

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Israel7 sites

  • Haemek Medical Center

    Afula, 18101

  • Barzilai Medical Center

    Ashkelon, 78278

  • Soroka

    Beersheba, 84101

  • Bnai-Zion medical center

    Haifa, 31048

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

Other trials in Israel

Poland5 sites

  • SPZOZ Zespol Szpitali Miejskich w Chorzowie

    Chorzów, 41500

  • Klinika Hematologii Collegium Medicum UJ

    Krakow, 31501

  • Oddzial Chorob Rozrostowych Regionalny Osrodek Onkologiczny

    Lodz, 93509

  • Medical University of Warsaw

    Warsaw, 02776

  • Klinika Nowotworow Ukladu Chlonnego- Centrum Onkologii

    Warsaw, 02781

Other trials in Poland

Portugal4 sites

  • Hospitais da Universidade de Coimbra

    Coimbra, 3000 - 075

  • Instituto Português de Oncologia de Lisboa de Francisco Gentil

    Lisbon, 1099 - 023

  • Hospital de Santa Maria

    Lisbon, 1649 - 035

  • IPO - Francisco Gentil - Porto

    Porto, 4200

Other trials in Portugal

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

About this study

Official title: Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line

This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy

For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.

Read the detailed description

Patients should have received at least 6 and up to 8 cycles of the R-CHOP 14 or R-CHOP 21 regimen or 6 R-CHOP-14 or -21 completed by 2 Rituximab alone in accordance to local preferences.

Patients can be registered to participate in the study at two time points:

  • At time of initial diagnosis and study enrolment (signature of informed consent) before the first cycle of treatment with R-CHOP.
  • At randomization (signature of informed consent) after treatment in first line with R-CHOP and have reached at least PR or CR.

Evaluation of the response to R-CHOP must be in accordance with Revised Response Criteria for Malignant Lymphoma(2007).

Stratification: Before randomization, the patients will be stratified according to the country and the response to R-CHOP (PR vs CR).

Randomization: Patients in CR/PR after R-CHOP will be randomized to maintenance therapy with lenalidomide or placebo.

Being tested
Lenalidomide, Placebo
Keywords
lenalidomide (Revlimid), diffuse large B-cell lymphoma, phase III study, after R-CHOP, Maintenance treatment, Maintenance
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • LenalidomideDrug

    Also called Revlimid

    Daily for 3 weeks every 4 weeks for 24 months

  • PlaceboDrug

    Daily for 3 weeks every 4 weeks for 24 months

Study groups in NCT01122472
Study groupRoleWhat they receive
LenalidomideExperimentalLenalidomide daily for 3 weeks every 4 weeks for 24 months
Receives: Drug: Lenalidomide
PlaceboPlacebo comparatorPlacebo daily for 3 weeks every 4 weeks for 24 months
Receives: Drug: Placebo

What is being measured

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

  1. Progression-Free-Survival (PFS)

    PFS will be measured from the date of randomization to the date of first documented disease progression or death. Progression data will be assigned to the earliest time when any progression is observed without prior missing assessments during the study up to the end of the follow up phase.

    Measured: Final PFS analysis will be realized when the number of events (160) has been reached or at the latest when the last patient into the study will finish follow up. The approximate schedule will be 75 months after the first patient randomized.

Secondary outcomes (6)

  1. Overall survival (OS)

    From the date of randomization to the date of death from any cause Interim analysis of OS will be performed at the time of the PFS final analysis; it is projected to have 97 deaths at this time. Final analysis of OS at the end of the study, defined by the last visit of follow-up for the last patient randomized, 5 years after its randomization

    Measured: 5 years

  2. Event-Free Survival (EFS)

    From the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause Interim analysis of EFS will be performed at the time of the PFS final analysis. Final analysis of OS at the end of the study, defined by the last visit of follow-up for the last patient randomized, 5 years after its randomization

    Measured: 5 years

  3. Response rate at the end of maintenance treatment

    Measured: 24 months

  4. Percentage of patients who convert from PR (partial response) to CR (complete response)

    Measured: 24 months

  5. Safety of lenalidomide in maintenance

    Toxicities occured during maintenance phase will be measured and reported from grade 2 for infection and neurological toxicities and from grade 3 for other toxicities according to CTCAE v3

    Measured: 5 years

  6. PFS2

    From randomization to objective tumor progression on next-line treatment or death from any cause

    Measured: 5 years

Timeline

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

  1. First posted13 May 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionJun 2016
  4. Study completionSep 2019

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
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01122472
Sponsor's protocol ID
REMARC
Acronym
REMARC
Status last verified
Jul 2021
First submitted
8 Apr 2010
Last updated
26 Jul 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Montagne A, Bertho G, Papastergiou T, Chartier L, Ricci R, Jardin F, Ghesquieres H, Rossi C, Morschhauser F, Haioun C, Ribrag V, Feugier P, Brisou G, Oberic L, Gaulard P, Giraud N, Bennani Y, Thieblemont C, Baud V. Risk stratification of patients with diffuse large B-cell lymphoma using plasma NMR-based metabolomics at diagnosis. Blood Adv. 2026 Jan 27;10(2):358-366. doi: 10.1182/bloodadvances.2025017248.

    PubMed 41056515

  • Beldi-Ferchiou A, Jais JP, Ghesquieres H, Casasnovas RO, Tilly H, Fruchart C, Morschhauser F, Haioun C, Lazarovici J, Perrot A, Nicolas-Virelizier E, Salles G, Godard N, Zamali I, De Colella JS, Claudel A, Corront B, Oberic L, Briere J, Gaulard P, Thieblemont C, Delfau-Larue MH. Lenalidomide maintenance fails to overcome the unfavourable prognosis of low NK-cell counts in rituximab-chemotherapy responsive elderly DLBCL patients: A LYSA group study. Br J Haematol. 2023 Apr;201(2):256-266. doi: 10.1111/bjh.18642. Epub 2023 Feb 6.

    PubMed 36740991

  • Girum KB, Rebaud L, Cottereau AS, Meignan M, Clerc J, Vercellino L, Casasnovas O, Morschhauser F, Thieblemont C, Buvat I. 18F-FDG PET Maximum-Intensity Projections and Artificial Intelligence: A Win-Win Combination to Easily Measure Prognostic Biomarkers in DLBCL Patients. J Nucl Med. 2022 Dec;63(12):1925-1932. doi: 10.2967/jnumed.121.263501. Epub 2022 Jun 16.

    PubMed 35710733

  • Cottereau AS, Meignan M, Nioche C, Capobianco N, Clerc J, Chartier L, Vercellino L, Casasnovas O, Thieblemont C, Buvat I. Risk stratification in diffuse large B-cell lymphoma using lesion dissemination and metabolic tumor burden calculated from baseline PET/CTdagger. Ann Oncol. 2021 Mar;32(3):404-411. doi: 10.1016/j.annonc.2020.11.019. Epub 2020 Dec 3.

    PubMed 33278600

  • Vercellino L, Cottereau AS, Casasnovas O, Tilly H, Feugier P, Chartier L, Fruchart C, Roulin L, Oberic L, Pica GM, Ribrag V, Abraham J, Simon M, Gonzalez H, Bouabdallah R, Fitoussi O, Sebban C, Lopez-Guillermo A, Sanhes L, Morschhauser F, Trotman J, Corront B, Choufi B, Snauwaert S, Godmer P, Briere J, Salles G, Gaulard P, Meignan M, Thieblemont C. High total metabolic tumor volume at baseline predicts survival independent of response to therapy. Blood. 2020 Apr 16;135(16):1396-1405. doi: 10.1182/blood.2019003526.

    PubMed 31978225

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide in people with Lymphoma and Diffuse Large B-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 157 sites in 9 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 19 inclusion and 11 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 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in France, Belgium, Spain, Australia, Austria and 4 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-Free-Survival (PFS) (time frame: Final PFS analysis will be realized when the number of events (160) has been reached or at the latest when the last patient into the study will finish follow up. The approximate schedule will be 75 months after the first patient randomized.). 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 NCT01122472, which also lists 5 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 26 Jul 2021.

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