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

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ClinicalTrials.gov Identifier: NCT03151408
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : October 25, 2019
Sponsor:
Collaborator:
Clinipace Worldwide
Information provided by (Responsible Party):
Helsinn Healthcare SA

Brief 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 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Pracinostat Drug: Placebos Drug: Azacitidine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 23, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: Pracinostat plus AZA
60 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.
Drug: Pracinostat
60 mg capsule
Other Name: SB939

Drug: Azacitidine
SC or IV injection
Other Name: AZA

Placebo Comparator: Placebo plus AZA
1 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.
Drug: Placebos
capsule

Drug: Azacitidine
SC or IV injection
Other Name: AZA




Primary Outcome Measures :
  1. Estimate efficacy rate [ Time Frame: from randomization until death from any cause, assessed up to 60 months ]
    To show superiority in terms of overall survival (OS) of treatment with pracinostat (Group A - experimental group) versus placebo (Group B - control group) in patients treated with AZA as background therapy


Secondary Outcome Measures :
  1. Morphologic Complete Remission (CR) rate [ Time Frame: from randomization until end of treatment, assessed up to 48 months ]
    The CR rate is the proportion of patients who achieve a morphologic CR according to the response criteria

  2. Event Free Survival (EFS) [ Time Frame: from randomization until death from any cause, assessed up to 60 months ]
    EFS is defined as the time from randomization to the first documented occurrence of disease progression or disease relapse after CR, or patient death from any cause, whichever occurs first

  3. Duration of Complete Remission [ Time Frame: from complete remission until relapse, assessed up to 60 months ]
    Duration of Complete Remission is the time from the first documented morphologic CR using the response criteria until documented relapse or death. Duration of CR is only defined for patients who achieve a morphologic CR.


Other Outcome Measures:
  1. Composite Complete Remission (cCR) rate [ Time Frame: from randomization until end of treatment, assessed up to 48 months ]
    Composite complete remission (cCR) rate is the proportion of patients who achieve either a disease response of CR, CRi or MLFS (i.e., cCR = CR + CRi + MLFS) within the study period, according to the response criteria

  2. Cytogenetic Complete Remission (CRc) rate [ Time Frame: from randomization until end of treatment, assessed up to 48 months ]
    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

  3. Molecular Complete Remission rate (CRm) [ Time Frame: from randomization until end of treatment, assessed up to 48 months ]
    The CRm rate is the proportion of patients who achieve a CR with MRD negativity by multicolor flow cytometry. CRm will be evaluated at the first patient's CR and then after further 4 cycles of treatment

  4. Duration of Composite Complete Remission [ Time Frame: from cCR until relapse, assessed up to 60 months ]
    Duration of cCR response is the time from first cCR until documented relapse (the definition of relapse from CR will be applied) or death. Duration of cCR is only defined for patients who achieve a cCR

  5. Duration of Cytogenetic Complete Remission [ Time Frame: from cytogenetic complete remission until relapse, assessed up to 60 months ]
    Duration of cytogenetic complete remission is the time from first CRc until documented relapse (defined as reappearance of abnormal karyotype or relapse from CR) or death. Duration of CRc is only defined for patients who achieve a CRc

  6. Transfusion Independence (TI) [ Time Frame: from randomization until end of treatment, assessed up to 48 months ]
    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

  7. Quality of Life [ Time Frame: from randomization until end of treatment, assessed up to 48 months ]
    Computation of the global health status and of selected functional scales and symptom scales from the EORTC QLQ-C30 questionnaire will be performed and their change from baseline over the study period will constitute the endpoints.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patient ≥ 18 years of age with newly diagnosed, histologically confirmed, AML including de novo, secondary to antecedent hematologic disorders, or treatment-related disease with intermediate or unfavorable-risk cytogenetics
  2. Unable to receive intensive chemotherapy regimens at enrollment, based on one of the following:

    I. Age ≥ 75 years, or

    II. Age < 75 years with at least 1 of the following co-morbidities:

    1. An ECOG performance status of 2
    2. Clinically significant cardiovascular disease defined as:

    i. 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

  3. 20% blasts in bone marrow
  4. 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.
  5. ECOG performance status ≤ 2
  6. Adequate organ function as evidenced by the following laboratory findings:

    1. Total bilirubin ≤ 2 × upper limit of normal (ULN) or < 3 x ULN for patients with Gilbert-Meulengracht Syndrome
    2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN
  7. Serum creatinine ≤ 1.5 × ULN according to institutional standards or creatinine clearance ≥ 50 mL/min
  8. QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 ms on electrocardiogram (ECG) at Screening
  9. 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
  10. 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
  11. Female patient who is of childbearing potential must have a negative serum pregnancy test result within 3 weeks prior to starting study drugs.
  12. Willing to provide voluntary written informed consent before performance of any study related procedure not part of normal medical care
  13. Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.

Exclusion Criteria:

  1. Able to receive intensive induction chemotherapy
  2. 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
  3. 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
  4. 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
  5. Uncontrolled arrhythmias; any Class 3-4 cardiac diseases as defined by the New York Heart Association (NYHA) functional classification
  6. Evidence of AML central nervous system (CNS) involvement
  7. Previous chemotherapy for AML except for the following, which are allowed:

    1. Hydroxyurea for cytoreduction
    2. 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)
  8. Use of experimental drugs ≤ 30 days prior to screening
  9. Received prior HDAC inhibitor therapy
  10. Received prior treatment with a hypomethylating agent, except as allowed in Exclusion Criterion 7.b
  11. Known hypersensitivity to any components of pracinostat, azacitidine, or mannitol
  12. History of human immunodeficiency virus (HIV) or an active and uncontrolled infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
  13. 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)
  14. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151408


Contacts
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Contact: Silvia Mappa, MD +41 91 985 18 78 silvia.mappa@helsinn.com

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Locations
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United States, Arizona
Mayo clinic hospital Recruiting
Phoenix, Arizona, United States, 85054
Arizona Oncology Associates, East Valley Cancer Center Recruiting
Tempe, Arizona, United States, 85284
University of Arizona cancer center-north campus Recruiting
Tucson, Arizona, United States, 85724
United States, California
10666 N.Torrey Pines-Scripps Cancer Center Recruiting
La Jolla, California, United States, 92037
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093-0698
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
United States, Idaho
Saint alphonsus Regional medical center-cancer care center Recruiting
Boise, Idaho, United States, 83706
United States, Illinois
Loyola University Chicago Recruiting
Maywood, Illinois, United States, 60153
United States, Kansas
Universitz of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
United States, Kentucky
Norton Cancer Institute, St. Matthews Campus Recruiting
Louisville, Kentucky, United States, 40207
United States, Louisiana
Pontchartrain Cancer Center (Research Location) Recruiting
Covington, Louisiana, United States, 70433
United States, Maryland
Rcca Md Llc Recruiting
Bethesda, Maryland, United States, 20187
United States, Massachusetts
UMass Memorial medical center-university campus Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Michigan Center of Medical Research Recruiting
Farmington Hills, Michigan, United States, 48336
Michigan State University Recruiting
Lansing, Michigan, United States, 48910
United States, Minnesota
Mayo clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Mercy Research Recruiting
Springfield, Missouri, United States, 65804
United States, Montana
100 Mercy Way Recruiting
Joplin, Montana, United States, 64804
United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Medical Center-2400 Pratt Street Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospital Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Mercy Clinic Oncology & Hematology Recruiting
Oklahoma City, Oklahoma, United States, 73120
Oklahoma cancer specialist and research institute Recruiting
Tulsa, Oklahoma, United States, 74146
United States, South Carolina
GHS Cancer Institute Recruiting
Greenville, South Carolina, United States, 29615
United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
United States, Texas
VA North texas Health Care sytem,Dallas VA Medical Center div. Hematology Oncology Recruiting
Dallas, Texas, United States, 75216
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Emily Couric Clinical cancer center Recruiting
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Thomas Reeve Chauncey Recruiting
Seattle, Washington, United States, 98108
Argentina
Hospital italiano de Buenos Aires Recruiting
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1181ACH
Instituto Medico Especializado Alexander Fleming Recruiting
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1426ANZ
hospital Italiano la Plata Recruiting
La Plata, Buenos Aires, Argentina, B1900AXI
Sanatorio Britanico SA Paraguay 40, 3P Recruiting
Rosario, Santa Fe, Argentina, 2000
sanatorio Allende Recruiting
Córdoba, Argentina, X5000JHQ
H ospi tal Privado de Cordoba Recruiting
Córdoba, Argentina, X5016KEH
Australia, New South Wales
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Australia, Queensland
Sunshine coast university hospital Recruiting
Birtinya, Queensland, Australia, 4575
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Australia, Victoria
The Northern hospital Pharmacy Department, Ground Floor Recruiting
Epping, Victoria, Australia, 3076
Barwon Health, University Hospital Geelong Recruiting
Geelong, Victoria, Australia, 3220
Austin Hospital, Clinical Trial Pharmacy Recruiting
Heidelberg, Victoria, Australia, 3084
Australia
Liverpool hospital Recruiting
Liverpool, Australia, 2170
Royal Perth Hospital Recruiting
Perth, Australia, 6000
Prince of Wales Hospital Recruiting
Randwick, Australia, 2031
Austria
Krankenhaus der Elisabethinen Linz GmbH Recruiting
Linz, Austria, 4020
Müllner Hauptstrabe 48 Recruiting
Salzburg, Austria, 5020
General Hospital Hietzing Recruiting
Vienna, Austria, 1130
Brazil
Liga Paranaense de Com bate ao Cancer - Hospital Erasto Gaertner Recruiting
Curitiba, Paranà, Brazil, 81520-060
Hospital de Cancer de Barretos Recruiting
Barretos, Brazil, 1478-400
Hospital Santa Casa de Belo Horizonte -Serviyo de Oncologia Clinica Recruiting
Belo Horizonte, Brazil, 30.150-221
Centro de Pesquisas Oncologicas - CEPON Recruiting
Florianópolis, Brazil, 88034-000
Hospital de ClÃ-nicas de Porto Alegre Recruiting
Porto Alegre, Brazil, 90035-903
Institute Nacional de Cancer Jose de Alencar Gomes da Silva-INCA Recruiting
Rio De Janeiro, Brazil, 20231-050
Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia Recruiting
Santo André, Brazil, 09060-870
Hospital de Base de Sao Jose do Rio Preto Recruiting
São José Do Rio Preto, Brazil, 15090-000
Czechia
"Fakultni nemocnice Hradec Kralove, Recruiting
Hradec Králové, Czechia, 5oo 05
Fakultni nemocnice Olomuc Recruiting
Olomouc, Czechia, 77900
Vseobecna fakultni nemocnice Recruiting
Praha 2, Czechia, I28 08
"Fakultni nemocnice Kralovske Vinohrady, Recruiting
Praha, Czechia, 100 34
Fakultni nemocnice Kralovske Vinohrady, Recruiting
Praha, Czechia, 10034
France
CHU Amiens Picardie-Site Sud-Service d'Hematologie Recruiting
Amiens, France, 800054
L'Hopital privé du Confluent SAS Recruiting
Nantes, France, 44277
CHU de Nice, Archet 1 Hospital-Hematology department Recruiting
Nice, France
Hospital saints Louis Recruiting
Paris, France, 75475
Haut-Leveque-Service d'hématologie clinique et de thérapie cellular Recruiting
Pessac, France, 33604
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Centre Henri Becquerel Recruiting
Rouen Cedex 1, France, 76028
Germany
Universitatsklinikum Erlangen Recruiting
Erlangen, Bavaria, Germany, 91054
Klinikum St. Marien Amberg Recruiting
Amberg, Bayern, Germany, 92224
Marien Hospital Herne-Universitätsklinikum der Ruhr-Universität Bochum Recruiting
Herne, North Rhine-westphalia, Germany, 44625
Charité-Universitätsmedizin - 1. Campus Mitte Recruiting
Berlin, Germany, 10117
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany, 09116
SRH Wald-Klinikum Gera GmbH Recruiting
Gera, Germany, 07548
Staedtisches krankenhaus kiel Recruiting
Kiel, Germany, 24116
Universitaet Mainz Recruiting
Mainz, Germany, 55131
Hungary
university of Pécs Recruiting
Pécs, Baranya, Hungary, 7624
Pecsi Egyetem I. Belgy6gyaszati Klinika Recruiting
Pécs, Baranya, Hungary, H-7624
St. Istvan & St. Laszlo Hospital, Deapartment of Hematology and Stem Cell Transplantation Recruiting
Budapest, Hungary, H-1097
University of Debrecen Clinical Center Recruiting
Debrecen, Hungary, H-4032
Somogy Megyei Kaposi Mor Oktato Korhaz, Dep. Of Haematology Recruiting
Kaposvár, Hungary, 7400
Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz â€" Josa Andras Oktatokorhaz, Hematologiai Osztaly Recruiting
Nyiregyhaza, Hungary, II-1065
Italy
Ospedale San Raffaele-U.O. Ematologia e TMO Recruiting
Milano, Lombardia, Italy, 20132
Ospedale la Maddalena, UO Oncoematologia e TMO Recruiting
Palermo, PA, Italy, 90146
AOU Policlinico Consorziale di Bari Recruiting
Bari, Italy, 70124
AOU Policlinico Sant'Orsola-Malpighi Recruiting
Bologna, Italy, 40138
Azienda Ospedaliera-Università Careggi Recruiting
Firenze, Italy, 50134
Ospedale Policlinico San Martino Recruiting
Genova, Italy, 16132
ospedale Vito Fazzi Recruiting
Lecce, Italy, 73100
Azienda Ospedaliere Antonio Cardarelli, Recruiting
Naples, Italy, 80131
Azienda Ospedaliera Universitaria Federico II Recruiting
Napoli, Italy, 80131
Fondazione IRCCS policlinico San Matteo Pavia Recruiting
Pavia, Italy, 27100
Fondazione PTV-Policlinico Tor Vergata Recruiting
Roma, Italy, 00133
Policlinico Universitario Gemelli Recruiting
Roma, Italy, 00168
Azienda Ospedaliera Ordine Mauriziano Recruiting
Torino, Italy, 10128
Korea, Republic of
Inje university Busan Paik Hospital Recruiting
Busan, Korea, Republic of, 47392
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Korea, Republic of, 58128
Gachon University Gil medical center, div hematology Recruiting
Incheon, Korea, Republic of, 21565
Seoul National University Hospital, Div.Hematology/Oncology Recruiting
Seoul, Korea, Republic of, 0080
Sumsung medical center Recruiting
Seoul, Korea, Republic of, 06351
Seoul St.Mary Hospital, div hemato-oncology Recruiting
Seoul, Korea, Republic of, 06591
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of, 44033
Poland
Examen Sp. Z o.o., Recruiting
Poznań, Poland, 60-192
Uniwersytecki Szpital Kliniczny Recruiting
Wrocław, Poland, 50-556
Wojewodzkie Wielospecjalistyczne Centrum onkologii I traumatologii Recruiting
Łódź, Poland, 93-513
Romania
Spitalul Clinic Filantropia Recruiting
Craiova, Jud.dolj, Romania, 200143
Spitalul Clinic Colentina Recruiting
Bucuresti, Romania, 020125
clinical hospital Coltea Bld Recruiting
Bucuresti, Romania, 030171
Oncological Institute "Ion Chiricuta" Recruiting
Cluj-Napoca, Romania, 400015
institutu Regional de Oncologie Iasi Recruiting
Iaşi, Romania, 700483
Spain
Institut Català D'Oncologia (ICO) Recruiting
Badalona, Barcelona, Spain, 08916
Hosp.Universitario A Coruña-Hospital Teresa Herrera Recruiting
A Coruña, Galicia, Spain, 15006
Hospital Universitario Son Espases Recruiting
Palma De Mallorca, Isla Baleares, Spain, 07120
"Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital de La Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08041
Hospital Universitario la Paz Recruiting
Madrid, Spain, 28046
Hospital Univers itario HM Sanchinarro Recruiting
Madrid, Spain, 28050
Hospital Uni vcrsitario de Salamanca Recruiting
Salamanca, Spain, 37007
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 46013
Hospital Universitario y Politecnico de La Fe Recruiting
Valencia, Spain, 46026
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan, 50006
Hematology and Oncology, Changhwa Christian Hospital Recruiting
Changhua, Taiwan, 500
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 83301
China Medical University Hospita Recruiting
Taichung, Taiwan, 40447
Division of Hematology, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
koo-Foundation Sun Yat-Sen Cancer Center Recruiting
Taipei, Taiwan, 112
United Kingdom
Royal Devon & Exeter Hospital (Wonford site) Recruiting
Exeter, Devon, United Kingdom, EX25DW
Blackpool Teaching Hospitals NHS Foundation Trust Recruiting
Blackpool, Lancashire, United Kingdom, FY3 8NR
Bradford Teaching Hospitals NHS Foundation trust Recruiting
Bradford, United Kingdom, BD9 6RJ
University Hospitals Coventry and Warwickshire NHS Trust Recruiting
Coventry, United Kingdom, CV2 2DX
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
Helsinn Healthcare SA
Clinipace Worldwide
Investigators
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Study Chair: Guillermo Garcia-Manero, MD MD Anderson

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Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT03151408     History of Changes
Other Study ID Numbers: PRAN-16-52
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helsinn Healthcare SA:
AML
Additional relevant MeSH terms:
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Azacitidine
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors