- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01650805
Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)
A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Expanded Access
Contacts and Locations
Study Locations
-
-
Australian Capital Territory
-
Garran, Australian Capital Territory, Australia, 2605
- Canberra Hospital, Site #971
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2065
- Royal North Shore Hospital, Site #941
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital, Site #951
-
-
Victoria
-
East Melbourne, Victoria, Australia, 3002
- The Peter MacCallum Cancer Center, Site #950
-
Melbourne, Victoria, Australia, 3128
- Box Hill Hospital, Site #940
-
-
Western Australia
-
Perth, Western Australia, Australia, 6000
- Royal Perth Hospital, Site #972
-
-
-
-
-
Wien, Austria, 01090
- Medizinische Universitat Wien / AKH, Universitatsklinik fur Inniere Medizin I, Site #561
-
-
-
-
-
Brussel, Belgium
- UZ Brussel - Department Hematology, Site #544
-
Bruxelles, Belgium, 3000
- Clinique Universitaire de Saint-Luc, Department of Haematology, Site #508
-
Gent, Belgium
- UZ Gent - Department Hematology, Site #756
-
Leuven, Belgium, 3000
- UZ Gasthuisberg - Department of Hematology, Site #700
-
-
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- University Health Network, Princess Margaret Hospital, Site #083
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital, Site #129
-
-
-
-
-
Brno, Czech Republic, 62500
- Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika, Site #514
-
Hradec Kralove, Czech Republic, 50005
- FN Hradec Kralove, Site #517
-
Olomouc, Czech Republic, 77520
- Fakultni nemocnice Olomouc, Hematoonkologicka klinika, Site #515
-
Praha, Czech Republic, 12808
- Ustav hematologie a krevni transfuse, Site #516
-
-
-
-
-
Helsinki, Finland
- Helsinki University Central Hospital, Site #542
-
-
-
-
-
Bordeaux, France
- Institut Bergonie, Site #772
-
Brest, France, 29200
- CHRU de Brest, Hopital Morvan, Site #523
-
Creteil Cedex, France, 94010
- CHU Henri Mondor, Site #520
-
Le Chesnay Cedex, France
- Centre Hospitalier de Versailles, Site #958
-
Lille Cedex, France, 59037
- Hospital Claude Huriez, Site #952
-
Marseille, France
- Institut Paoli Calmette, Site #519
-
Nancy Cedex, France
- CHU de Brabois, Site #953
-
Nantes Cedex, France, 44093
- CHU de Nantes, Site #521
-
Nice Cedex, France, 06202
- Service Hematologie - Hospital Archet I, Site #509
-
Paris, France, 75475
- Hopital Saint-Louis, Site #957
-
Paris, France
- Hospital Saint Antoine, Site #518
-
Pierre Benite, France, 69495
- Centre Hospitalier Lyon Sud, Site #956
-
Poitiers, France, 86021
- CHU de Poitiers, Site #954
-
Toulouse Cedex, France
- CHU Purpan, Site #955
-
-
-
-
-
Aachen, Germany, 52074
- Universitätsklinikum Aachen, AÖR, Site #513
-
Berlin, Germany, 13353
- Charite - Universitatsmedizin Berlin, Site #701
-
Dresden, Germany, 01307
- Universitatsklinikum Carl Gustav Carus an der TU Dresden, Site #526
-
Freiburg, Germany
- Universitatsklinikum Freiburg, Site #527
-
Hamburg, Germany, 20246
- Universitatsklinikum Hamburg-Eppendorf, Site #524
-
Jena, Germany, 07747
- Universitatsklinikum Jena, Site #946
-
Koln, Germany, 50937
- Universitatsklinikum Koln-AOR, Site #525
-
Mannheim, Germany, 68167
- Universitat Heidelberg, CML - Studienzentrale III. Medizinische Klinik, Site #947
-
Munchen, Germany, 81675
- Klinikum rechts der Isar, Site #949
-
-
-
-
-
Hong Kong, Hong Kong
- Prince of Wales Hospital, Site #974
-
Hong Kong, Hong Kong
- Queen Mary Hospital, Site #973
-
-
-
-
-
Bari, Italy, 70124
- Unita Operativa di Ematologia con Trapianto, Site #529
-
Bologna, Italy, 40138
- Istituto di Ematologia "L. & A. Seragnoli", Site #959
-
Catania, Italy, 95124
- A.O. Universitaria Policlinico Vittorio Emanuele di Catania, Site #530
-
Genova, Italy, 16132
- Clinica Ematologica, Site #528
-
Milan, Italy, 20162
- Ospedale Niguarda Ca' Granda di Milano, Site #531
-
Modena, Italy, 41124
- S.C. Ematologia, Site #960
-
Monza, Italy, 20900
- San Gerardo Hospital, Site #961
-
Napoli, Italy, 80131
- U.O.C Ematologia con trapianto di midollo osseo, Site #560
-
Napoli, Italy
- Universita Federico II, Site #510
-
Orbassano, Italy, 10043
- SCDU Medicina Interna II - Indirizzo Ematologico, Site #785
-
Rome, Italy, 00161
- Dipartimento di Biotecnologie Cellulari ed Ematologia Universita La Sapienza - Policlinico Umberto I, Site #511
-
Rome, Italy, 144
- U.O. di Ematologia - Ospedale S. Eugenio, Site #962
-
-
-
-
Seoul
-
Seocho-gu, Seoul, Korea, Republic of, 137-701
- The Catholic University of Korea, Site #938
-
-
-
-
-
Amsterdam, Netherlands, 1081-HV
- VU Medical Centre - Department Haematology, Site #948
-
-
-
-
-
Christchurch, New Zealand
- Christchurch Hospital, Site #922
-
Hamilton, New Zealand
- Waikato Hospital, Site #977
-
Takapuna, New Zealand, 0740
- North Shore Hospital, Site #976
-
-
Auckland
-
Grafton, Auckland, New Zealand, 1023
- Auckland City Hospital, Site #921
-
-
-
-
-
Gdansk, Poland
- Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Medyczne, Site #548
-
Krakow, Poland
- Malopolskie Centrum Medyczne, Site #546
-
Lodz, Poland
- Klinika Hematologii Wojewodzkiego Szpitala Specjalistycznego, Site #550
-
Rzeszow, Poland, 35-055
- Oddzial Hematologii, Site #551
-
Wroclaw, Poland
- Katedra i Klinika Hematologii, Site #547
-
-
-
-
-
Lisboa, Portugal, 1099-023
- Instituto Portugues de Oncologia, Site #545
-
-
-
-
-
San Juan, Puerto Rico, 00927
- Fundacion de Investigacion de Diego, Site #199
-
-
-
-
-
Singapore, Singapore
- Singapore General Hospital, Site #939
-
-
-
-
-
Bratislava, Slovakia, 833 10
- Narodny onkologicky ustav, Site #532
-
Martin, Slovakia, 036 59
- Univerzitna nemocnica Martin, Site #533
-
-
-
-
-
A Coruna, Spain, 15006
- Complejo Hospitalario Universitario A Coruna, Hospital "Teresa Herrera," Site #554
-
Badalona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol, Site #512
-
Barcelona, Spain, 08036
- Hospital Clinic, Site #963
-
Girona, Spain, 17007
- Institut Catala d' Oncologia de Girona, S. de Hematologia Clinica, Site #734
-
Islas Baleares, Spain, 07010
- Hospital Universitari Son Espases, Site #553
-
Madrid, Spain, 28006
- Hospital Universitario La Princesa, Site #555
-
Madrid, Spain, 28007
- Hospital Gregorio Maranon, Site #536
-
Madrid, Spain, 28034
- H.U. Ramon y Cajal, Site #538
-
Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre, Site #537
-
Madrid, Spain, 28046
- Hospital La Paz, Site #966
-
Oviedo, Spain, 33006
- Hospital Universitario Central de Asturias, Site #535
-
Salamanca, Spain, 37007
- Hospital Universitario de Salamanca, Site #965
-
Valencia, Spain, 46010
- Hospital Clinico Universitario de Valencia, Site #964
-
-
-
-
-
Lund, Sweden
- Skane University Hospital, Site #944
-
Stockholm, Sweden
- Karolinska University Hospital Huddinge, Site #534
-
Stockholm, Sweden
- Karolinska University Hospital Solna, Site #763
-
Uppsala, Sweden
- Uppsala University Hospital, Site #945
-
-
-
-
-
Aarau, Switzerland, 5001
- Kantonsspital Aarau, Site #541
-
St Gallen, Switzerland, 9007
- Kantonsspital St. Gallen, Site #707
-
-
-
-
-
Kaohsiung, Taiwan
- Kaohsiung Chang Gung Memorial Hospital, Site #980
-
Taiching, Taiwan, 40447
- China Medical University Hospital, Site #978
-
Taipei, Taiwan, 10002
- National Taiwan University Hospital, Site #979
-
-
-
-
-
Edinburgh, United Kingdom, EH4 2XU
- Western General Hospital, Site #556
-
Gillingham, United Kingdom
- Kent and Medway Cancer Research Network, Site #558
-
Glasgow, United Kingdom, G120SB
- University of Glasgow, Site #797
-
Leeds, United Kingdom, LS9 7TF
- St. James University Hospital, Site #540
-
Liverpool, United Kingdom, L7 8XP
- Royal Liverpool University Hospital, Site #969
-
London, United Kingdom
- Hammersmith Hospital, Site #967
-
Newcastle, United Kingdom
- Newcastle University, Site #970
-
Norwich, United Kingdom
- Norfolk & Norwich University Hospital Foundation Trust, Site #557
-
Nottingham, United Kingdom, NG5 1PB
- Nottingham University Hospitals NHS Trust, Site #968
-
Oxford, United Kingdom
- Oxford University Hospitals NHS Trust, Site #543
-
-
-
-
California
-
Burbank, California, United States, 91505
- US Oncology - Providence Health System, Site #167
-
Los Angeles, California, United States, 90095
- UCLA Department of Medicine, Site #027
-
Pleasant Hill, California, United States, 94523
- Bay Area Cancer Research Group, Site #156
-
Pleasant Hill, California, United States, 94523
- Bay Area Cancer Research Group, Site #157
-
-
Colorado
-
Boulder, Colorado, United States, 80303
- Rocky Mountain Cancer Centers, Site #191
-
-
Connecticut
-
Southington, Connecticut, United States, 06489
- Cancer Center of Central Connecticut, Site #147
-
-
Delaware
-
Newark, Delaware, United States, 19713
- Christiana Care Health Services, Site #155
-
-
Florida
-
Boynton Beach, Florida, United States, 33426
- University Cancer Institute, Site #149
-
Fort Meyers, Florida, United States, 33916
- Florida Cancer Specialists, Site #180
-
St. Petersburg, Florida, United States, 33705
- Florida Cancer Specialists, Site #179
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University, Site #058
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- John H. Stroger, Jr. Hospital of Cook County, Site #192
-
Chicago, Illinois, United States, 60637
- University of Chicago, Site #001
-
Maywood, Illinois, United States, 60153
- Loyola University Chicago, Site #054
-
-
Indiana
-
Indianapolis, Indiana, United States, 46237
- Franciscan St. Francis Health, Site #138
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics, Site #050
-
Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates, Site #198
-
-
Kansas
-
Wichita, Kansas, United States, 67214
- US Oncology - Cancer Center of Kansas, Site #168
-
-
Louisiana
-
Shreveport, Louisiana, United States, 71103
- Willis-Knighton Cancer Center, Site #196
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland, Greenebaum Cancer Center, Site #040
-
Baltimore, Maryland, United States, 21204
- Greater Baltimore Medical Center, Site #140
-
Baltimore, Maryland, United States, 21229
- St. Agnes Healthcare, Site #185
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital, Site #047
-
Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute, Site #008
-
Worcester, Massachusetts, United States, 01655
- University of Massachusetts Worcester, Site #152
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Medical Center, Site #011
-
Southfield, Michigan, United States, 48075
- Providence Cancer Institute, Site #197
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic, Site #044
-
St. Louis Park, Minnesota, United States, 55426
- Oncology Research Park Nicollet Institute, Site #195
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- Saint Luke's Hospital, Site #162
-
Springfield, Missouri, United States, 65804
- Mercy Clinic - Cancer & Hematology, Site #151
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68506
- Nebraska Hematology-Oncology, P.C., Site # 133
-
-
Nevada
-
Las Vegas, Nevada, United States, 89169
- US Oncology - Comprehensive Cancer Center of Nevada, Site #169
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- John Theurer Cancer Center, Site #128
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- University of New Mexico Cancer Center, Site #166
-
-
New York
-
Brooklyn, New York, United States, 11220
- Maimonides Cancer Center, Site #177
-
Mineola, New York, United States, 11501
- Winthrop University Hospital, Site #153
-
New York, New York, United States, 10003
- Beth Israel Medical Center, Site #145
-
New York, New York, United States, 10029
- Mount Sinai School of Medicine, Site #189
-
New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center, Site #078
-
New York, New York, United States, 10065
- Weill Cornell Medical College, Site #006
-
Valhalla, New York, United States, 10595
- New York Medical College, Site #146
-
-
North Carolina
-
Goldsboro, North Carolina, United States, 27534
- Southeastern Medical Oncology Center, Site #188
-
-
Ohio
-
Middletown, Ohio, United States, 45042
- Signal Point Clinical Research Center, Site #139
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma, Site #028
-
-
Oregon
-
Portland, Oregon, United States, 97213
- Providence Cancer Center Oncology and Hematology Care Eastside, Site #194
-
Portland, Oregon, United States, 97227
- Kaiser Permanente Northwest, Site #200
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University, Site #048
-
-
Pennsylvania
-
Gettysburg, Pennsylvania, United States, 17325
- Gettysburg Cancer Center, Site #160
-
Pittsburgh, Pennsylvania, United States, 15224
- Western Pennsylvania Hospital, Site #159
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina, Site #148
-
Sumter, South Carolina, United States, 29150
- Carolina Hematology Oncology, Site #143
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37421
- Associates in Oncology & Hematology, Site #186
-
Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute, Site #076
-
-
Texas
-
Austin, Texas, United States, 78705
- US Oncology - Texas Oncology Austin, Site #172
-
Dallas, Texas, United States, 75231
- US Oncology - Texas Oncology Dallas, Site #171
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center, Site #178
-
Houston, Texas, United States, 77030
- Baylor College of Medicine, Site #063
-
Midland, Texas, United States, 79701
- US Oncology - Texas Oncology Midland, Site #173
-
San Antonio, Texas, United States, 78229
- US Oncology - Cancer Care Center of South Texas, Site #170
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute, Site #043
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- VCU Massey Cancer Center, Dalton Oncology Clinic, Site #069
-
-
Washington
-
Seattle, Washington, United States, 98109
- Seattle Cancer Care Alliance, Site #100
-
Vancouver, Washington, United States, 98684
- US Oncology - Northwest Cancer Specialists, Site #174
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26506
- West Virginia University, Site #154
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54303
- Green Bay Oncology, Ltd. / St. Mary's Hospital Medical Center, Site #193
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin, Site #030
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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:
(a) 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ponatinib
|
45 mg tablet, taken orally once daily
|
Active Comparator: imatinib
|
400 mg tablet, taken orally once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Molecular Response (MMR) Rate at 12 Months
Time Frame: 12 months after first dose
|
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.
|
12 months after first dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MMR Rate
Time Frame: 5 years after first dose
|
To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years
|
5 years after first dose
|
<10% BCR-ABL^IS Rate
Time Frame: 3 months after first dose
|
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
|
3 months after first dose
|
Complete Cytogenetic Response (CCyR) Rate
Time Frame: 12 months after first dose
|
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.
|
12 months after first dose
|
Progression-free Survival
Time Frame: Up to 8 years after the last patient's first dose
|
To compare, according to treatment with ponatinib versus imatinib, progression-free survival
|
Up to 8 years after the last patient's first dose
|
Overall Survival
Time Frame: Up to 8 years after the last patient's first dose
|
To compare, according to treatment with ponatinib versus imatinib, overall survival
|
Up to 8 years after the last patient's first dose
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
- Ponatinib
Other Study ID Numbers
- AP24534-12-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Myeloid Leukemia
-
Newcastle UniversityBristol-Myers Squibb; Institute of Cancer Research, United Kingdom; Newcastle-upon-Tyne... and other collaboratorsCompletedMyeloid Leukemia, Chronic, Chronic PhaseUnited Kingdom
-
Asan Medical CenterTerminatedLeukemia, Chronic Myeloid | Myeloid Leukemia, Chronic, Chronic Phase | Myeloid Leukemia, Chronic, Accelerated PhaseKorea, Republic of
-
Bristol-Myers SquibbTerminatedLeukemia, Myeloid, ChronicSweden, United Kingdom, Russian Federation, France, Germany, Belgium, Portugal, Finland, Norway, Spain, Italy
-
University of BolognaCompletedMyeloid Leukemia, Chronic, Chronic-PhaseItaly
-
PETHEMA FoundationCompleted
-
Bristol-Myers SquibbWithdrawnMyeloid Leukemia, Chronic, Chronic-PhaseUnited States
-
Fundacion Espanola para la Curacion de la Leucemia...Pfizer; Roche Farma, S.ATerminatedChronic Phase-Chronic Myeloid LeukemiaSpain
-
TakedaActive, not recruitingMyeloid Leukemia, Chronic, Chronic PhaseUnited States, Spain, Taiwan, Australia, Canada, Russian Federation, Sweden, Switzerland, Germany, United Kingdom, Poland, Korea, Republic of, Argentina, Hong Kong, Singapore, Italy, Chile, Czechia, Denmark, France, Portugal
-
Associazione Italiana Pazienti Leucemia Mieloide...Not yet recruitingChronic Myeloid Leukemia (CML)Italy
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletedChronic Myelogenous Leukemia - Chronic PhaseChina
Clinical Trials on ponatinib
-
Associazione Italiana Pazienti Leucemia Mieloide...Not yet recruitingChronic Myeloid Leukemia (CML)Italy
-
Ariad PharmaceuticalsCompletedChronic Myeloid Leukemia (CML) | Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)Japan
-
Dana-Farber Cancer InstituteCompleted
-
Dana-Farber Cancer InstituteTerminatedNon-Small Cell Lung Cancer, Head and Neck CancerUnited States
-
Memorial Sloan Kettering Cancer CenterCompletedNon Small Cell Lung Cancer | KRAS Gene MutationUnited States
-
Ariad PharmaceuticalsTerminatedChronic Phase Chronic Myeloid LeukemiaBelgium
-
Sebastian BauerHannover Medical School; University Hospital Tuebingen; Universitätsmedizin Mannheim and other collaboratorsUnknownGIST, Malignant | KIT Gene Mutation | KIT Exon 13 MutationGermany
-
Ariad PharmaceuticalsApproved for marketingChronic Myeloid Leukemia (CML) | Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)United States
-
Versailles HospitalActive, not recruiting
-
Hospices Civils de LyonCompleted