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Chronic Myeloid LeukemiaPhase 3NCT01650805

Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

A Phase 3 study testing ponatinib and imatinib (Gleevec/ Glivec) in people with Chronic Myeloid Leukemia, run by Ariad Pharmaceuticals at 170 sites in 24 countries.

Terminated

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

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
ponatinib and imatinib (Gleevec/ Glivec)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
307 participants
Where
170 sitesin 24 countries
Study dates
Jun 2012to Oct 2013
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

  • CP CML within 6 months of diagnosis
  • CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv) ≥100 × 10^9/L platelets (≥100,000/mm^3); (v) No evidence of extramedullary disease except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or BP-CML
  • Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22) Philadelphia chromosome
  • (a)Variant translocations are only allowed provided they are assessable for cytogenetic response utilizing conventional cytogenetic techniques; (b) Conventional chromosome banding must be performed; AND (c) A minimum of 20 metaphases must be assessable at entry
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Adequate hepatic function as defined by the following criteria:
Show all 9Show fewer
  • Total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome; (b) Alanine aminotransferase (ALT) ≤2.5 × ULN; AND (c) Aspartate aminotransferase (AST) ≤2.5 × ULN
  • Adequate renal function as defined as defined by serum creatinine <1.5 x ULN
  • Adequate pancreatic function as defined by serum lipase and amylase ≤1.5 × ULN

Who cannot join

  • Received prior imatinib therapy
  • Received prior dasatinib therapy
  • Received prior nilotinib therapy
  • Received, for CML, any other systemic anticancer therapy, experimental therapy, or radiation therapy with the exception of anagrelide or hydroxyurea
  • Major surgery within 28 days prior to initiating therapy
  • History of bleeding disorder unrelated to CML
Show all 26Show fewer
  • History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
  • History of alcohol abuse
  • Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
  • Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
  • Myocardial infarction, within 6 months prior to randomization
  • Unstable angina within 6 months prior to randomization
  • Congestive heart failure within 6 months prior to randomization
  • History of clinically significant (as determined by the treating physician) atrial arrhythmia or any ventricular arrhythmia
  • Any history of ventricular arrhythmia
  • Cerebrovascular accident or transient ischemic attack within 6 months prior to randomization
  • Any history of peripheral arterial occlusive disease requiring revascularization
  • Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism
  • Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control
  • Taking medications that are known to be associated with Torsades de Pointes
  • Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection
  • Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history
  • Pregnant or breastfeeding
  • Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs
  • Diagnosed with or received anticancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)
  • Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug

Trial locations and contacts

170 sites in 24 countries.

170 sites in 24 countries

United States67 sites

  • University of New Mexico Cancer Center, Site #166

    Albuquerque, New Mexico, 87106

  • University of Michigan Medical Center, Site #011

    Ann Arbor, Michigan, 48109

  • Emory University, Site #058

    Atlanta, Georgia, 30322

  • US Oncology - Texas Oncology Austin, Site #172

    Austin, Texas, 78705

  • University of Maryland, Greenebaum Cancer Center, Site #040

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center, Site #140

    Baltimore, Maryland, 21204

  • St. Agnes Healthcare, Site #185

    Baltimore, Maryland, 21229

  • Massachusetts General Hospital, Site #047

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute, Site #008

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers, Site #191

    Boulder, Colorado, 80303

  • University Cancer Institute, Site #149

    Boynton Beach, Florida, 33426

  • Maimonides Cancer Center, Site #177

    Brooklyn, New York, 11220

  • US Oncology - Providence Health System, Site #167

    Burbank, California, 91505

  • Medical University of South Carolina, Site #148

    Charleston, South Carolina, 29425

  • Associates in Oncology & Hematology, Site #186

    Chattanooga, Tennessee, 37421

  • John H. Stroger, Jr. Hospital of Cook County, Site #192

    Chicago, Illinois, 60612

  • University of Chicago, Site #001

    Chicago, Illinois, 60637

  • US Oncology - Texas Oncology Dallas, Site #171

    Dallas, Texas, 75231

  • University of Texas Southwestern Medical Center, Site #178

    Dallas, Texas, 75390

  • Florida Cancer Specialists, Site #180

    Fort Meyers, Florida, 33916

  • Gettysburg Cancer Center, Site #160

    Gettysburg, Pennsylvania, 17325

  • Southeastern Medical Oncology Center, Site #188

    Goldsboro, North Carolina, 27534

  • Green Bay Oncology, Ltd. / St. Mary's Hospital Medical Center, Site #193

    Green Bay, Wisconsin, 54303

  • John Theurer Cancer Center, Site #128

    Hackensack, New Jersey, 07601

  • Baylor College of Medicine, Site #063

    Houston, Texas, 77030

  • Franciscan St. Francis Health, Site #138

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics, Site #050

    Iowa City, Iowa, 52242

  • Saint Luke's Hospital, Site #162

    Kansas City, Missouri, 64111

  • US Oncology - Comprehensive Cancer Center of Nevada, Site #169

    Las Vegas, Nevada, 89169

  • Nebraska Hematology-Oncology, P.C., Site # 133

    Lincoln, Nebraska, 68506

  • UCLA Department of Medicine, Site #027

    Los Angeles, California, 90095

  • University of Wisconsin, Site #030

    Madison, Wisconsin, 53792

  • Loyola University Chicago, Site #054

    Maywood, Illinois, 60153

  • Signal Point Clinical Research Center, Site #139

    Middletown, Ohio, 45042

  • US Oncology - Texas Oncology Midland, Site #173

    Midland, Texas, 79701

  • Winthrop University Hospital, Site #153

    Mineola, New York, 11501

  • West Virginia University, Site #154

    Morgantown, West Virginia, 26506

  • Sarah Cannon Research Institute, Site #076

    Nashville, Tennessee, 37203

  • Beth Israel Medical Center, Site #145

    New York, New York, 10003

  • Mount Sinai School of Medicine, Site #189

    New York, New York, 10029

  • Memorial Sloan-Kettering Cancer Center, Site #078

    New York, New York, 10065

  • Weill Cornell Medical College, Site #006

    New York, New York, 10065

  • Christiana Care Health Services, Site #155

    Newark, Delaware, 19713

  • University of Oklahoma, Site #028

    Oklahoma City, Oklahoma, 73104

  • Western Pennsylvania Hospital, Site #159

    Pittsburgh, Pennsylvania, 15224

  • Bay Area Cancer Research Group, Site #156

    Pleasant Hill, California, 94523

  • Bay Area Cancer Research Group, Site #157

    Pleasant Hill, California, 94523

  • Providence Cancer Center Oncology and Hematology Care Eastside, Site #194

    Portland, Oregon, 97213

  • Kaiser Permanente Northwest, Site #200

    Portland, Oregon, 97227

  • Oregon Health & Science University, Site #048

    Portland, Oregon, 97239

  • VCU Massey Cancer Center, Dalton Oncology Clinic, Site #069

    Richmond, Virginia, 23298

  • Mayo Clinic, Site #044

    Rochester, Minnesota, 55905

  • Oncology Research Park Nicollet Institute, Site #195

    Saint Louis Park, Minnesota, 55426

  • Huntsman Cancer Institute, Site #043

    Salt Lake City, Utah, 84112

  • US Oncology - Cancer Care Center of South Texas, Site #170

    San Antonio, Texas, 78229

  • Seattle Cancer Care Alliance, Site #100

    Seattle, Washington, 98109

  • Willis-Knighton Cancer Center, Site #196

    Shreveport, Louisiana, 71103

  • Siouxland Hematology-Oncology Associates, Site #198

    Sioux City, Iowa, 51101

  • Providence Cancer Institute, Site #197

    Southfield, Michigan, 48075

  • Cancer Center of Central Connecticut, Site #147

    Southington, Connecticut, 06489

  • Mercy Clinic - Cancer & Hematology, Site #151

    Springfield, Missouri, 65804

  • Florida Cancer Specialists, Site #179

    St. Petersburg, Florida, 33705

  • Carolina Hematology Oncology, Site #143

    Sumter, South Carolina, 29150

  • New York Medical College, Site #146

    Valhalla, New York, 10595

  • US Oncology - Northwest Cancer Specialists, Site #174

    Vancouver, Washington, 98684

  • US Oncology - Cancer Center of Kansas, Site #168

    Wichita, Kansas, 67214

  • University of Massachusetts Worcester, Site #152

    Worcester, Massachusetts, 01655

Other trials in United States

France14 sites

  • Institut Bergonie, Site #772

    Bordeaux

  • CHRU de Brest, Hopital Morvan, Site #523

    Brest, 29200

  • CHU Henri Mondor, Site #520

    Créteil, 94010

  • Centre Hospitalier de Versailles, Site #958

    Le Chesnay

  • Hospital Claude Huriez, Site #952

    Lille, 59037

  • Institut Paoli Calmette, Site #519

    Marseille

  • CHU de Brabois, Site #953

    Nancy

  • CHU de Nantes, Site #521

    Nantes, 44093

  • Service Hematologie - Hospital Archet I, Site #509

    Nice, 06202

  • Hopital Saint-Louis, Site #957

    Paris, 75475

  • Hospital Saint Antoine, Site #518

    Paris

  • Centre Hospitalier Lyon Sud, Site #956

    Pierre-Bénite, 69495

  • CHU de Poitiers, Site #954

    Poitiers, 86021

  • CHU Purpan, Site #955

    Toulouse

Other trials in France

Spain13 sites

  • Complejo Hospitalario Universitario A Coruna, Hospital "Teresa Herrera," Site #554

    A Coruña, 15006

  • Hospital Universitari Germans Trias i Pujol, Site #512

    Badalona, 08916

  • Hospital Clinic, Site #963

    Barcelona, 08036

  • Institut Catala d' Oncologia de Girona, S. de Hematologia Clinica, Site #734

    Girona, 17007

  • Hospital Universitari Son Espases, Site #553

    Islas Baleares, 07010

  • Hospital Universitario La Princesa, Site #555

    Madrid, 28006

  • Hospital Gregorio Maranon, Site #536

    Madrid, 28007

  • H.U. Ramon y Cajal, Site #538

    Madrid, 28034

  • Hospital Universitario 12 de Octubre, Site #537

    Madrid, 28041

  • Hospital La Paz, Site #966

    Madrid, 28046

  • Hospital Universitario Central de Asturias, Site #535

    Oviedo, 33006

  • Hospital Universitario de Salamanca, Site #965

    Salamanca, 37007

  • Hospital Clinico Universitario de Valencia, Site #964

    Valencia, 46010

Other trials in Spain

Italy12 sites

  • Unita Operativa di Ematologia con Trapianto, Site #529

    Bari, 70124

  • Istituto di Ematologia "L. & A. Seragnoli", Site #959

    Bologna, 40138

  • A.O. Universitaria Policlinico Vittorio Emanuele di Catania, Site #530

    Catania, 95124

  • Clinica Ematologica, Site #528

    Genova, 16132

  • Ospedale Niguarda Ca' Granda di Milano, Site #531

    Milan, 20162

  • S.C. Ematologia, Site #960

    Modena, 41124

  • San Gerardo Hospital, Site #961

    Monza, 20900

  • U.O.C Ematologia con trapianto di midollo osseo, Site #560

    Naples, 80131

  • Universita Federico II, Site #510

    Naples

  • SCDU Medicina Interna II - Indirizzo Ematologico, Site #785

    Orbassano, 10043

  • Dipartimento di Biotecnologie Cellulari ed Ematologia Universita La Sapienza - Policlinico Umberto I, Site #511

    Rome, 00161

  • U.O. di Ematologia - Ospedale S. Eugenio, Site #962

    Rome, 144

Other trials in Italy

United Kingdom10 sites

  • Western General Hospital, Site #556

    Edinburgh, EH4 2XU

  • Kent and Medway Cancer Research Network, Site #558

    Gillingham

  • University of Glasgow, Site #797

    Glasgow, G120SB

  • St. James University Hospital, Site #540

    Leeds, LS9 7TF

  • Royal Liverpool University Hospital, Site #969

    Liverpool, L7 8XP

  • Hammersmith Hospital, Site #967

    London

  • Newcastle University, Site #970

    Newcastle

  • Norfolk & Norwich University Hospital Foundation Trust, Site #557

    Norwich

  • Nottingham University Hospitals NHS Trust, Site #968

    Nottingham, NG5 1PB

  • Oxford University Hospitals NHS Trust, Site #543

    Oxford

Other trials in United Kingdom

Germany9 sites

  • Universitätsklinikum Aachen, AÖR, Site #513

    Aachen, 52074

  • Charite - Universitatsmedizin Berlin, Site #701

    Berlin, 13353

  • Universitatsklinikum Koln-AOR, Site #525

    Cologne, 50937

  • Universitatsklinikum Carl Gustav Carus an der TU Dresden, Site #526

    Dresden, 01307

  • Universitatsklinikum Freiburg, Site #527

    Freiburg im Breisgau

  • Universitatsklinikum Hamburg-Eppendorf, Site #524

    Hamburg, 20246

  • Universitatsklinikum Jena, Site #946

    Jena, 07747

  • Universitat Heidelberg, CML - Studienzentrale III. Medizinische Klinik, Site #947

    Mannheim, 68167

  • Klinikum rechts der Isar, Site #949

    München, 81675

Other trials in Germany

Australia6 sites

  • Royal Adelaide Hospital, Site #951

    Adelaide, South Australia, 5000

  • The Peter MacCallum Cancer Center, Site #950

    East Melbourne, Victoria, 3002

  • Canberra Hospital, Site #971

    Garran, Australian Capital Territory, 2605

  • Box Hill Hospital, Site #940

    Melbourne, Victoria, 3128

  • Royal Perth Hospital, Site #972

    Perth, Western Australia, 6000

  • Royal North Shore Hospital, Site #941

    Sydney, New South Wales, 2065

Other trials in Australia

Poland5 sites

  • Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Medyczne, Site #548

    Gdansk

  • Malopolskie Centrum Medyczne, Site #546

    Krakow

  • Klinika Hematologii Wojewodzkiego Szpitala Specjalistycznego, Site #550

    Lodz

  • Oddzial Hematologii, Site #551

    Rzeszów, 35-055

  • Katedra i Klinika Hematologii, Site #547

    Wroclaw

Other trials in Poland

Belgium4 sites

  • Clinique Universitaire de Saint-Luc, Department of Haematology, Site #508

    Brussels, 3000

  • UZ Brussel - Department Hematology, Site #544

    Brussels

  • UZ Gent - Department Hematology, Site #756

    Ghent

  • UZ Gasthuisberg - Department of Hematology, Site #700

    Leuven, 3000

Other trials in Belgium

Czechia4 sites

  • Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika, Site #514

    Brno, 62500

  • FN Hradec Kralove, Site #517

    Hradec Králové, 50005

  • Fakultni nemocnice Olomouc, Hematoonkologicka klinika, Site #515

    Olomouc, 77520

  • Ustav hematologie a krevni transfuse, Site #516

    Prague, 12808

Other trials in Czechia

New Zealand4 sites

  • Christchurch Hospital, Site #922

    Christchurch

  • Auckland City Hospital, Site #921

    Grafton, Auckland, 1023

  • Waikato Hospital, Site #977

    Hamilton

  • North Shore Hospital, Site #976

    Takapuna, 0740

Other trials in New Zealand

Sweden4 sites

  • Skane University Hospital, Site #944

    Lund

  • Karolinska University Hospital Huddinge, Site #534

    Stockholm

  • Karolinska University Hospital Solna, Site #763

    Stockholm

  • Uppsala University Hospital, Site #945

    Uppsala

Other trials in Sweden

Taiwan3 sites

  • Kaohsiung Chang Gung Memorial Hospital, Site #980

    Kaohsiung City

  • China Medical University Hospital, Site #978

    Taiching, 40447

  • National Taiwan University Hospital, Site #979

    Taipei, 10002

Other trials in Taiwan

Canada2 sites

  • Jewish General Hospital, Site #129

    Montreal, Quebec, H3T 1E2

  • University Health Network, Princess Margaret Hospital, Site #083

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Hong Kong2 sites

  • Prince of Wales Hospital, Site #974

    Hong Kong

  • Queen Mary Hospital, Site #973

    Hong Kong

Other trials in Hong Kong

Slovakia2 sites

  • Narodny onkologicky ustav, Site #532

    Bratislava, 833 10

  • Univerzitna nemocnica Martin, Site #533

    Martin, 036 59

Other trials in Slovakia

Switzerland2 sites

  • Kantonsspital Aarau, Site #541

    Aarau, 5001

  • Kantonsspital St. Gallen, Site #707

    Sankt Gallen, 9007

Other trials in Switzerland

Austria1 site

  • Medizinische Universitat Wien / AKH, Universitatsklinik fur Inniere Medizin I, Site #561

    Vienna, 01090

Other trials in Austria

Finland1 site

  • Helsinki University Central Hospital, Site #542

    Helsinki

Other trials in Finland

Netherlands1 site

  • VU Medical Centre - Department Haematology, Site #948

    Amsterdam, 1081-HV

Other trials in Netherlands

Portugal1 site

  • Instituto Portugues de Oncologia, Site #545

    Lisbon, 1099-023

Other trials in Portugal

Puerto Rico1 site

  • Fundacion de Investigacion de Diego, Site #199

    San Juan, 00927

Other trials in Puerto Rico

Singapore1 site

  • Singapore General Hospital, Site #939

    Singapore

Other trials in Singapore

South Korea1 site

  • The Catholic University of Korea, Site #938

    Seocho-gu, Seoul, 137-701

Other trials in South Korea

About this study

Official title: A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.

Read the detailed description

This multicenter, international, phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib.

Patients will be randomized in a 1:1 fashion, stratified by Sokal risk score at diagnosis (low, intermediate, high), to receive once daily oral administration of either ponatinib or imatinib. Efficacy measures include molecular, cytogenetic, and hematologic response rates at various timepoints; time to, duration of, and durability of responses; and survival follow-up. Safety measures include clinical laboratory testing, adverse event monitoring, vital signs, physical exams, ECGs, and ECHOs. Other measures include two patient-reported health outcomes questionnaires (FACT-Leu and EQ-5D-5L), determination of mutation status, and, for ponatinib only, measurement of steady-state plasma concentration. Accrual is expected to take approximately 2 years, and patients will be followed for survival for up to 8 years after the last patient's first dose; therefore, patient participation may last up to 10 years.

Being tested
ponatinib, imatinib (Gleevec/ Glivec)
Keywords
Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Myeloproliferative Disorders, Bone Marrow Diseases, Hematologic Diseases
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Leukemia, Myeloid, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders

What participants receive

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

  • ponatinibDrug

    45 mg tablet, taken orally once daily

  • imatinib (Gleevec/ Glivec)Drug

    400 mg tablet, taken orally once daily

Study groups in NCT01650805
Study groupRoleWhat they receive
ponatinibExperimentalNot described
Receives: Drug: ponatinib
imatinibActive comparatorNot described
Receives: Drug: imatinib (Gleevec/ Glivec)

What is being measured

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

  1. Major Molecular Response (MMR) Rate at 12 Months

    A ratio of reverse transcribed transcript of BCR-ABL to ABL ≤ 0.1% on the international scale, measured by real-time quantitative polymerase chain reaction.

    Measured: 12 months after first dose

Secondary outcomes (5)

  1. MMR Rate

    To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years

    Measured: 5 years after first dose

  2. <10% BCR-ABL^IS Rate

    To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib

    Measured: 3 months after first dose

  3. Complete Cytogenetic Response (CCyR) Rate

    The percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. Responses are defined as follows: Complete (CCyR): 0% Ph+ metaphases.

    Measured: 12 months after first dose

  4. Progression-free Survival

    To compare, according to treatment with ponatinib versus imatinib, progression-free survival

    Measured: Up to 8 years after the last patient's first dose

  5. Overall Survival

    To compare, according to treatment with ponatinib versus imatinib, overall survival

    Measured: Up to 8 years after the last patient's first dose

Timeline

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

  1. First posted26 Jul 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionOct 2013
  4. Study completionOct 2013

Why it stopped: Study terminated based on evaluation of safety data.

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
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01650805
Sponsor's protocol ID
AP24534-12-301
Status last verified
Oct 2014
First submitted
18 Jul 2012
Last updated
17 Nov 2014
Data monitoring committee
Yes
Expanded access
Available

Publications

  • Hanley MJ, Diderichsen PM, Narasimhan N, Srivastava S, Gupta N, Venkatakrishnan K. Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model-Informed Dose Selection for Pediatric Development. J Clin Pharmacol. 2022 Apr;62(4):555-567. doi: 10.1002/jcph.1990. Epub 2021 Dec 16.

    PubMed 34699069

  • Lipton JH, Chuah C, Guerci-Bresler A, Rosti G, Simpson D, Assouline S, Etienne G, Nicolini FE, le Coutre P, Clark RE, Stenke L, Andorsky D, Oehler V, Lustgarten S, Rivera VM, Clackson T, Haluska FG, Baccarani M, Cortes JE, Guilhot F, Hochhaus A, Hughes T, Kantarjian HM, Shah NP, Talpaz M, Deininger MW; EPIC investigators. Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2016 May;17(5):612-21. doi: 10.1016/S1470-2045(16)00080-2. Epub 2016 Apr 12.

    PubMed 27083332

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ponatinib and imatinib (Gleevec/ Glivec) in people with Chronic Myeloid Leukemia, run by Ariad Pharmaceuticals at 170 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 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 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, France, Spain, Italy, United Kingdom and 19 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 21 Oct 2014). 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?

Major Molecular Response (MMR) Rate at 12 Months (time frame: 12 months after first dose). 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 NCT01650805, which also lists 2 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 17 Nov 2014.

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