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

November 5, 2014 updated by: Ariad Pharmaceuticals

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.

Study Overview

Status

Terminated

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

Interventional

Enrollment (Actual)

307

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. 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
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  4. 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

  5. Adequate renal function as defined as defined by serum creatinine <1.5 x ULN
  6. Adequate pancreatic function as defined by serum lipase and amylase ≤1.5 × ULN

Exclusion Criteria:

  1. Received prior imatinib therapy
  2. Received prior dasatinib therapy
  3. Received prior nilotinib therapy
  4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or radiation therapy with the exception of anagrelide or hydroxyurea
  5. Major surgery within 28 days prior to initiating therapy
  6. History of bleeding disorder unrelated to CML
  7. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
  8. History of alcohol abuse
  9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
  10. Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:

    1. Myocardial infarction, within 6 months prior to randomization
    2. Unstable angina within 6 months prior to randomization
    3. Congestive heart failure within 6 months prior to randomization
    4. History of clinically significant (as determined by the treating physician) atrial arrhythmia or any ventricular arrhythmia
    5. Any history of ventricular arrhythmia
    6. Cerebrovascular accident or transient ischemic attack within 6 months prior to randomization
    7. Any history of peripheral arterial occlusive disease requiring revascularization
    8. Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism
  11. 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
  12. Taking medications that are known to be associated with Torsades de Pointes
  13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection
  14. Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history
  15. Pregnant or breastfeeding
  16. Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs
  17. 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)
  18. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

October 1, 2014

More Information

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.

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