AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 3NCT03151408

An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia

A Phase 3 study testing Pracinostat and Azacitidine in people with Acute Myeloid Leukemia, run by Helsinn Healthcare SA at 138 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and cytogenetic low-risk AML, who are unfit to receive… 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?
Pracinostat and Azacitidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
138 sitesin 16 countries
Study dates
23 Jun 2017to 20 Aug 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

  • Male or female patient ≥ 18 years of age with newly diagnosed, histologically or cytologically confirmed, AML including de novo, secondary to antecedent hematologic disorders, or treatment-related disease with intermediate or unfavorable-risk cytogenetics
  • Unable to receive intensive chemotherapy regimens at enrollment, based on one of the following:
  • Age ≥ 75 years, or
  • Age < 75 years with at least 1 of the following co-morbidities:
  • An ECOG performance status of 2
  • Clinically significant cardiovascular disease defined as:
Show all 20Show fewer
  • Left ventricular ejection fraction (LVEF) ≤ 50%, measured within 3 months prior to Day 1 confirmed by ECHO/MUGA ii. Congestive heart failure requiring medical therapy iii. Chronic stable angina requiring medical therapy iv. Prior cerebrovascular accident with sequelae c. Clinically significant pulmonary disease defined as: i. Forced expiratory volume in 1 second (FEV1) ≤ 65% of expected ii. Lung diffusing capacity for carbon monoxide (DLCO) ≤ 65% of expected Confirmed by pulmonary tests. d. Diabetes mellitus with symptomatic end-organ damage (e.g., retinopathy, nephropathy, neuropathy, vasculopathy) e. Autoimmune inflammatory conditions (e.g., rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, or similar) requiring chronic disease modifying therapy (e.g., etanercept, adalimumab, infliximab, rituximab, methotrexate, or similar) f. Class III obesity defined as a Body Mass Index (BMI) > 40 kg/m2 g. Renal impairment defined as serum creatinine > 1.3 mg/dL (> 115 µmol/L) or creatinine clearance <70 ml/min h. Clinically significant cognitive impairment defined as requiring medical therapy and/or assistance with activities of daily living
  • 20% blasts in bone marrow
  • Peripheral white blood cell (WBC) count 30,000/µL For cyto-reduction, hydroxyurea is allowed during screening and up to Cycle 1, Days 1-14, to reduce WBC count to < 30,000 µL prior to Day 1. After Cycle 1, Day 14, hydroxyurea is prohibited.
  • ECOG performance status ≤ 2
  • Adequate organ function as evidenced by the following laboratory findings:
  • Total bilirubin ≤ 2 × upper limit of normal (ULN) or < 3 x ULN for patients with Gilbert-Meulengracht Syndrome
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN
  • Serum creatinine ≤ 1.5 × ULN according to institutional standards or creatinine clearance ≥ 50 mL/min
  • QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 ms on electrocardiogram (ECG) at Screening
  • Male patient who is surgically sterile, or male patient who is willing to agree to remain completely abstinent (refrain from heterosexual intercourse) or who use barrier contraceptive measures and agree to refrain from donating sperm during the entire study treatment period and for 3 months after the last administration of study drug
  • Female patient who is of childbearing potential willing to use adequate contraceptive measures while participating on study, OR willing to completely abstain from heterosexual intercourse during the entire study treatment period
  • Female patient who is of childbearing potential must have a negative serum pregnancy test result within 3 weeks prior to starting study drugs.
  • Willing to provide voluntary written informed consent before performance of any study related procedure not part of normal medical care
  • Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.

Who cannot join

  • Able to receive intensive induction chemotherapy
  • AML-associated inv(16)/t(16;16)/del(16q), t(15;17) (i.e. promyelocytic leukemia) with/without secondary aberrations; t(8;21) lacking del (9q) or complex karyotypes
  • Presence of an active malignant disease within the last 12 months, with the exception of adequately treated cervical cancer in-situ, non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria]). Other malignancies may be considered after consultation with the Medical Monitor
  • Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the Investigator's opinion, could compromise the patient's safety or put the study outcomes at risk
  • Uncontrolled arrhythmias; any Class 3-4 cardiac diseases as defined by the New York Heart Association (NYHA) functional classification
  • Evidence of AML central nervous system (CNS) involvement
Show all 21Show fewer
  • Previous chemotherapy for AML except for the following, which are allowed:
  • Hydroxyurea for cytoreduction
  • One course of hypomethylating agent therapy (i.e.; up to 7 doses of azacitidine or 3-5 days of decitabine) within 30 days prior to enrollment (Day 1)
  • Use of experimental drugs ≤ 30 days prior to screening
  • Received prior HDAC inhibitor therapy
  • Received prior treatment with a hypomethylating agent, except as allowed in Exclusion Criterion 7.b
  • Known hypersensitivity to any components of pracinostat, azacitidine, or mannitol
  • History of human immunodeficiency virus (HIV) or an active and uncontrolled infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
  • Gastrointestinal (GI) tract disease that causes an inability to take oral medication, malabsorption syndrome, or a requirement for IV alimentation; prior surgical procedures affecting absorption; or uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis)
  • Any disease(s), psychiatric condition, metabolic dysfunction, or findings from a physical examination or clinical laboratory test result that would cause reasonable suspicion of a disease or condition, that contraindicates the use of pracinostat and/or AZA, that may increase the risk associated with study participation, that may affect the interpretation of the results, or that would make the patient inappropriate for this study
  • Breast-feeding woman
  • current smokers(use of patches, chewing gums and vaping nicotine conaining fluids is permitted). Patients who stopped smoking at least 8 day prior to first pracinostat dosing can be enrolled, provided they refrain from smoking during the whole study
  • prohibited concomitant medications
  • uncontrolled infections
  • receive more than 1 prior cycle of HMA or bone marrow transplant for any prior hematological disorder antecedent to AML

Trial locations and contacts

138 sites in 16 countries.

138 sites in 16 countries

United States30 sites

  • Rcca Md Llc

    Bethesda, Maryland, 20187

  • Saint alphonsus Regional medical center-cancer care center

    Boise, Idaho, 83706

  • Emily Couric Clinical cancer center

    Charlottesville, Virginia, 22908

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Pontchartrain Cancer Center (Research Location)

    Covington, Louisiana, 70433

  • VA North texas Health Care sytem,Dallas VA Medical Center div. Hematology Oncology

    Dallas, Texas, 75216

  • Duke University Medical Center-2400 Pratt Street

    Durham, North Carolina, 27710

  • Michigan Center of Medical Research

    Farmington Hills, Michigan, 48336

  • GHS Cancer Institute

    Greenville, South Carolina, 29615

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • 100 Mercy Way

    Joplin, Montana, 64804

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • 10666 N.Torrey Pines-Scripps Cancer Center

    La Jolla, California, 92037

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093-0698

  • Michigan State University

    Lansing, Michigan, 48910

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207

  • Loyola University Chicago

    Maywood, Illinois, 60153

  • Mercy Clinic Oncology & Hematology

    Oklahoma City, Oklahoma, 73120

  • Mayo clinic hospital

    Phoenix, Arizona, 85054

  • Mayo clinic

    Rochester, Minnesota, 55905

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Thomas Reeve Chauncey

    Seattle, Washington, 98108

  • Mercy Research

    Springfield, Missouri, 65804

  • Stony Brook University

    Stony Brook, New York, 11794

  • Arizona Oncology Associates, East Valley Cancer Center

    Tempe, Arizona, 85284

  • University of Arizona cancer center-north campus

    Tucson, Arizona, 85724

  • Oklahoma cancer specialist and research institute

    Tulsa, Oklahoma, 74146

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Universitz of Kansas Cancer Center

    Westwood, Kansas, 66205

  • UMass Memorial medical center-university campus

    Worcester, Massachusetts, 01655

Other trials in United States

Italy13 sites

  • AOU Policlinico Consorziale di Bari

    Bari, 70124

  • AOU Policlinico Sant'Orsola-Malpighi

    Bologna, 40138

  • Azienda Ospedaliera-Università Careggi

    Florence, 50134

  • Ospedale Policlinico San Martino

    Genova, 16132

  • ospedale Vito Fazzi

    Lecce, 73100

  • Ospedale San Raffaele-U.O. Ematologia e TMO

    Milan, Lombardy, 20132

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Azienda Ospedaliere Antonio Cardarelli,

    Naples, 80131

  • Ospedale la Maddalena, UO Oncoematologia e TMO

    Palermo, PA, 90146

  • Fondazione IRCCS policlinico San Matteo Pavia

    Pavia, 27100

  • Fondazione PTV-Policlinico Tor Vergata

    Roma, 00133

  • Policlinico Universitario Gemelli

    Roma, 00168

  • Azienda Ospedaliera Ordine Mauriziano

    Torino, 10128

Other trials in Italy

Spain12 sites

  • Hosp.Universitario A Coruña-Hospital Teresa Herrera

    A Coruña, Galicia, 15006

  • Institut Català D'Oncologia (ICO)

    Badalona, Barcelona, 08916

  • "Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital San Pedro de Alcantara

    Cáceres, Extremadura, 10003

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario la Paz

    Madrid, 28046

  • Hospital Univers itario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Son Espases

    Palma de Mallorca, Isla Baleares, 07120

  • Hospital Uni vcrsitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio

    Seville, 46013

  • Hospital Universitario y Politecnico de La Fe

    Valencia, 46026

Other trials in Spain

Brazil10 sites

  • Hospital de Cancer de Barretos

    Barretos, 1478-400

  • Hospital Santa Casa de Belo Horizonte -Serviyo de Oncologia Clinica

    Belo Horizonte, 30.150-221

  • Liga Paranaense de Com bate ao Cancer - Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Centro de Pesquisas Oncologicas - CEPON

    Florianópolis, 88034-000

  • Ce ntro de Pesquisas Hospital Amara l Ca rvalh o

    Jaú, São Paulo, 17210-080

  • Hospital de ClÃ-nicas de Porto Alegre

    Porto Alegre, 90035-903

  • Institute Nacional de Cancer Jose de Alencar Gomes da Silva-INCA

    Rio de Janeiro, 20231-050

  • Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, 09060-870

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, 15090-000

  • Centro de Pesquisa Clinica do Hospital Santa Marcelina

    São Paulo, São Paulo, 0827-120

Other trials in Brazil

Australia9 sites

  • Sunshine coast university hospital

    Birtinya, Queensland, 4575

  • The Northern hospital Pharmacy Department, Ground Floor

    Epping, Victoria, 3076

  • Barwon Health, University Hospital Geelong

    Geelong, Victoria, 3220

  • Austin Hospital, Clinical Trial Pharmacy

    Heidelberg, Victoria, 3084

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Liverpool hospital

    Liverpool, 2170

  • Royal Perth Hospital

    Perth, 6000

  • Prince of Wales Hospital

    Randwick, 2031

Other trials in Australia

Germany8 sites

  • Klinikum St. Marien Amberg

    Amberg, Bavaria, 92224

  • Charité-Universitätsmedizin - 1. Campus Mitte

    Berlin, 10117

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Universitatsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • SRH Wald-Klinikum Gera GmbH

    Gera, 07548

  • Marien Hospital Herne-Universitätsklinikum der Ruhr-Universität Bochum

    Herne, North Rhine-Westphalia, 44625

  • Staedtisches krankenhaus kiel

    Kiel, 24116

  • Universitaet Mainz

    Mainz, 55131

Other trials in Germany

France7 sites

  • CHU Amiens Picardie-Site Sud-Service d'Hematologie

    Amiens, 800054

  • L'Hopital privé du Confluent SAS

    Nantes, 44277

  • CHU de Nice, Archet 1 Hospital-Hematology department

    Nice

  • Hospital saints Louis

    Paris, 75475

  • Haut-Leveque-Service d'hématologie clinique et de thérapie cellular

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Henri Becquerel

    Rouen, 76028

Other trials in France

South Korea7 sites

  • Inje university Busan Paik Hospital

    Busan, 47392

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

  • Gachon University Gil medical center, div hematology

    Incheon, 21565

  • Seoul National University Hospital, Div.Hematology/Oncology

    Seoul, 0080

  • Sumsung medical center

    Seoul, 06351

  • Seoul St.Mary Hospital, div hemato-oncology

    Seoul, 06591

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • Hematology and Oncology, Changhwa Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • China Medical University Hospita

    Taichung, 40447

  • Division of Hematology, National Taiwan University Hospital

    Taipei, 100

  • koo-Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

Other trials in Taiwan

Argentina6 sites

  • Hospital italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1181ACH

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1426ANZ

  • sanatorio Allende

    Córdoba, X5000JHQ

  • H ospi tal Privado de Cordoba

    Córdoba, X5016KEH

  • hospital Italiano la Plata

    La Plata, Buenos Aires, B1900AXI

  • Sanatorio Britanico SA Paraguay 40, 3P

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Hungary6 sites

  • St. Istvan & St. Laszlo Hospital, Deapartment of Hematology and Stem Cell Transplantation

    Budapest, H-1097

  • University of Debrecen Clinical Center

    Debrecen, H-4032

  • Somogy Megyei Kaposi Mor Oktato Korhaz, Dep. Of Haematology

    Kaposvár, 7400

  • Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz â€" Josa Andras Oktatokorhaz, Hematologiai Osztaly

    Nyíregyháza, II-1065

  • university of Pécs

    Pécs, Baranya, 7624

  • Pecsi Egyetem I. Belgy6gyaszati Klinika

    Pécs, Baranya, H-7624

Other trials in Hungary

Romania6 sites

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • clinical hospital Coltea Bld

    Bucharest, 030171

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098

  • Oncological Institute "Ion Chiricuta"

    Cluj-Napoca, 400015

  • Spitalul Clinic Filantropia

    Craiova, Jud.dolj, 200143

  • institutu Regional de Oncologie Iasi

    Iași, 700483

Other trials in Romania

Czechia5 sites

  • "Fakultni nemocnice Hradec Kralove,

    Hradec Králové, 5oo 05

  • Fakultni nemocnice Olomuc

    Olomouc, 77900

  • "Fakultni nemocnice Kralovske Vinohrady,

    Prague, 100 34

  • Fakultni nemocnice Kralovske Vinohrady,

    Prague, 10034

  • Vseobecna fakultni nemocnice

    Prague, I28 08

Other trials in Czechia

United Kingdom5 sites

  • Blackpool Teaching Hospitals NHS Foundation Trust

    Blackpool, Lancashire, FY3 8NR

  • Bradford Teaching Hospitals NHS Foundation trust

    Bradford, BD9 6RJ

  • University Hospitals Coventry and Warwickshire NHS Trust

    Coventry, CV2 2DX

  • Royal Devon & Exeter Hospital (Wonford site)

    Exeter, Devon, EX25DW

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

Other trials in United Kingdom

Poland4 sites

  • Wojewodzkie Wielospecjalistyczne Centrum onkologii I traumatologii

    Lodz, 93-513

  • Examen Sp. Z o.o.,

    Poznan, 60-192

  • Specjalistyc:my Szpi tal im. dra Alfreda Sokolowskiego

    Wałbrzych, 58-309

  • Uniwersytecki Szpital Kliniczny

    Wroclaw, 50-556

Other trials in Poland

Austria3 sites

  • Krankenhaus der Elisabethinen Linz GmbH

    Linz, 4020

  • Müllner Hauptstrabe 48

    Salzburg, 5020

  • General Hospital Hietzing

    Vienna, 1130

Other trials in Austria

About this study

Official title: A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ≥18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy

This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of each cycle. Study treatment should continue until there is documented disease progression, relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may be required to achieve a complete remission. Once permanently discontinued from study treatment, patients will enter the Long-term Follow-up phase of the study and will be followed for assessment of disease progression, if applicable, and survival every 3 months (±1 month) until death. The end of this study is defined when 390 events (deaths) have occurred and the study is unblinded for final overall survival analysis. Patients who are receiving study treatment at the end of the study may have the opportunity to continue to receive the study drugs to which they were randomized to (Post- Study Observation Period), until the Sponsor informs the Investigators of the appropriate course of action based on the study results. The Post-Study Observation Period is defined as the period starting from the end of the study for a maximum of 12 months.

Being tested
Pracinostat, Placebos, Azacitidine
Keywords
AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • PracinostatDrug

    Also called SB939

    60 mg capsule

  • PlacebosDrug

    capsule

  • AzacitidineDrug

    Also called AZA

    SC or IV injection

Study groups in NCT03151408
Study groupRoleWhat they receive
Pracinostat plus AZAExperimental60 mg capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.
Receives: Drug: Pracinostat; Drug: Azacitidine
Placebo plus AZAPlacebo comparator1 capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.
Receives: Drug: Placebos; Drug: Azacitidine

What is being measured

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

  1. Overall Survival

    OS measures the time from randomization to death due to any cause.

    Measured: 826 days

Secondary outcomes (4)

  1. Morphologic Complete Remission (CR) Rate

    The CR rate is the proportion of patients who achieve a morphologic CR according to the response criteria

    • <5% blasts in a bone marrow aspirate sample with spicules
    • There should be no blasts with Auer rods
    • No EMD
    • Absolute Neutrophil Count (ANC) ≥1,000/μL
    • Platelet count of ≥100,000/μL
    • Patient must be independent of transfusions (for at least 1week before each assessment)

    Measured: 744 days

  2. Complete Remission Without Minimal Residual Disease (CRmrd) Rate

    proportion of patients who achieve a CR without minimal residual disease by multicolor flow cytometry according to the following criteria

    • Morphologic CR
    • Minimal Residual Disease (MRD) by MFC negative

    Measured: 826 days

  3. Cytogenetic Complete Remission (CRc) Rate

    The CRc rate is the proportion of patients who achieve a reversion to a normal karyotype at CR within the study period. This endpoint applies only to patients with abnormal cytogenetic at enrollment according to the following criterion

    Morphologic CR plus reversion to a normal karyotype (defined as no clonal abnormalities detected in a minimum of 20 mitotic cells)

    Measured: 826 days

  4. Transfusion Independence (TI)

    Transfusion independence rate is defined as the proportion of patients who show eight weeks or over without red blood cell (RBC-TI) and/or platelet (PLT-TI) transfusion during study period

    Measured: 826 days

Timeline

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

  1. First posted12 May 2017
  2. Study start23 Jun 2017
  3. Primary completion20 Aug 2020
  4. Study completion20 Aug 2020

Why it stopped: The IDMC recommended to stop the study prematurely due to a lack of efficacy.

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
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03151408
Sponsor's protocol ID
PRAN-16-52
Status last verified
Feb 2022
First submitted
5 May 2017
Last updated
10 Mar 2022
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pracinostat and Azacitidine in people with Acute Myeloid Leukemia, run by Helsinn Healthcare SA at 138 sites in 16 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 20 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: stopped early, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Italy, Spain, Brazil, Australia and 11 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 10 Mar 2022). 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: 826 days). 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 NCT03151408.

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 10 Mar 2022.

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