A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
ENESTnd
A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
2 other identifiers
interventional
846
35 countries
213
Brief Summary
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2007
Longer than P75 for phase_3
213 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2007
CompletedFirst Posted
Study publicly available on registry
May 10, 2007
CompletedStudy Start
First participant enrolled
July 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2009
CompletedResults Posted
Study results publicly available
June 17, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2019
CompletedNovember 18, 2020
October 1, 2020
2.1 years
May 7, 2007
April 10, 2013
October 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Major Molecular Response Rate (MMR) at 12 Months Between All 3 Arms - With Imputation
MMR is defined as the percentage of participants in MMR (reduction of ≥ 3 logs in BCR-ABL transcripts compared to the standardized baseline established in IRIS, or ≤ 0.1% BCR-ABL/ABL % by international scale and measured by real-time quantitative polymerase chain reaction (RQ-PCR)) at 12 months.
Baseline, 12 months
Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation
MMR is defined as the percentage of participants in MMR (reduction of ≥ 3 logs in BCR-ABL transcripts compared to the standardized baseline established in IRIS, or ≤ 0.1% BCR-ABL/ABL % by international scale and measured by real-time quantitative polymerase chain reaction (RQ-PCR)) at 12 months.
12 months
Secondary Outcomes (28)
Rates of Durable MMR at 24 Months Between All 3 Arms
24 months
Rate of Complete Cytogenetic Response (CCyR) in Nilotinib Treatment Arms With Imatinib at 12 Months and Beyond 12 Months
12, 24, 36, 48, 60, 72 months (M)
Rate of Major Molecular Response (MMR) at 12 Months Between Two Nilotinib Arms
12 months
Rate of MMR at 6 Months and Beyond in All 3 Treatment Arms
6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months
Rate of a ≥ 4 Log Reduction in BCR-ABL Transcripts in Nilotinib Treatment Arms With Imatinib
at 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months
- +23 more secondary outcomes
Study Arms (3)
nilotinib 300mg bid (investigating arm)
EXPERIMENTALNilotinb 400 mg bid (investigating arm)
EXPERIMENTALimatinib 400mg QD (control arm)
EXPERIMENTALInterventions
Nilotinib was supplied as 50 mg, 150 mg and 200 mg hard gelatin capsules and administered orally at 300 mg BID (twice a day) or 400 mg BID (twice a day)depending on the randomized dose.
Imatinib was supplied as 100 mg and 400 mg tablets and administered orally at 400 mg QD (once a day).
Eligibility Criteria
You may qualify if:
- Chronic myelogenous leukemia in chronic phase patients within the first 6 months of diagnosis.
- Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome of (9:22) translocations
You may not qualify if:
- Previously documented T315I mutation
- Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except for no more than 2 weeks in duration of imatinib
- Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
- Impaired cardiac function.
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
- Currently receiving treatment with any medications that have the potential to prolong the QT interval.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (213)
University of California at Los Angeles Dept. of Hematology Clinic
Los Angeles, California, 90095, United States
Kaiser Permanente - California Southern Dept of Kaiser South 3
San Diego, California, 92120, United States
Kaiser Permanente - California Northern Vallejo Med Center/Med Offices
Vallejo, California, 94589, United States
Kaiser Permanente - California Northern Kaiser Med
Vallejo, California, 94609, United States
Rocky Mountain Cancer Centers RMCC - Colorado Springs
Greenwood Village, Colorado, United States
Florida Cancer Specialists Dept. FloridaCancerSpecialists
Fort Myers, Florida, 33901, United States
Advanced Medical Specialties Research Dept.
Miami, Florida, 33176, United States
Cancer Centers of Florida PA Cancer Centers of FL
Ocoee, Florida, 34761, United States
Florida Retina Institute Flordia Cancer Affilates
Orlando, Florida, 32804, United States
University of Chicago Section of Hematology/Oncology
Chicago, Illinois, 60637, United States
Indiana Blood and Marrow Institute Dept. of Indiana Blood&Marrow
Beech Grove, Indiana, 46107, United States
University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&Clinics
Iowa City, Iowa, 52242, United States
Kansas City Cancer Center KCCC Business Office
Overland Park, Kansas, 66210, United States
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
New Orleans, Louisiana, 70115, United States
Michigan State University / Breslin Cancer Center Breslin Cancer Center
Lansing, Michigan, 48824, United States
Missouri Cancer Associates Dept. of Boone Hospital Center
Columbia, Missouri, 65201, United States
Hematology Oncology Consultants, Inc. Deptof Hem. Onc.Consunsultants
St Louis, Missouri, 63136, United States
Hackensack University Medical Center Department of Research
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center Clinical Trials Office
New York, New York, 10021, United States
University of North Carolina UNC Lineberger Cancer Center
Chapel Hill, North Carolina, 27514, United States
Wake Forest University Health Sciences Dept. of Industry Research
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati / Barrett Cancer Center Dept.of Internal Med.
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation CCF
Cleveland, Ohio, 44195, United States
Northwest Cancer Specialists Compass Oncology -BKM
Portland, Oregon, 97210, United States
Cancer Centers of the Carolinas CC of C -Eastside
Greenville, South Carolina, 29605, United States
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology Dept. of Centennial Medical
Nashville, Tennessee, 37203, United States
Texas Cancer Center ( Medical City Dallas Hospital)
Dallas, Texas, 75230, United States
Cancer Care Centers of South Texas HOAST CCC of So.TX- Medical Center
San Antonio, Texas, 78229, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
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Related Publications (8)
Hughes TP, Hochhaus A, Kantarjian HM, Cervantes F, Guilhot F, Niederwieser D, le Coutre PD, Rosti G, Ossenkoppele G, Lobo C, Shibayama H, Fan X, Menssen HD, Kemp C, Larson RA, Saglio G. Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily. Haematologica. 2014 Jul;99(7):1204-11. doi: 10.3324/haematol.2013.091272. Epub 2014 Feb 14.
PMID: 24532039DERIVEDHughes TP, Saglio G, Kantarjian HM, Guilhot F, Niederwieser D, Rosti G, Nakaseko C, De Souza CA, Kalaycio ME, Meier S, Fan X, Menssen HD, Larson RA, Hochhaus A. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood. 2014 Feb 27;123(9):1353-60. doi: 10.1182/blood-2013-06-510396. Epub 2013 Dec 11.
PMID: 24335106DERIVEDHochhaus A, Saglio G, Larson RA, Kim DW, Etienne G, Rosti G, De Souza C, Kurokawa M, Kalaycio ME, Hoenekopp A, Fan X, Shou Y, Kantarjian HM, Hughes TP. Nilotinib is associated with a reduced incidence of BCR-ABL mutations vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase. Blood. 2013 May 2;121(18):3703-8. doi: 10.1182/blood-2012-04-423418. Epub 2013 Mar 15.
PMID: 23502220DERIVEDBranford S, Kim DW, Soverini S, Haque A, Shou Y, Woodman RC, Kantarjian HM, Martinelli G, Radich JP, Saglio G, Hochhaus A, Hughes TP, Muller MC. Initial molecular response at 3 months may predict both response and event-free survival at 24 months in imatinib-resistant or -intolerant patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase treated with nilotinib. J Clin Oncol. 2012 Dec 10;30(35):4323-9. doi: 10.1200/JCO.2011.40.5217. Epub 2012 Oct 29.
PMID: 23109697DERIVEDLarson RA, Yin OQ, Hochhaus A, Saglio G, Clark RE, Nakamae H, Gallagher NJ, Demirhan E, Hughes TP, Kantarjian HM, le Coutre PD. Population pharmacokinetic and exposure-response analysis of nilotinib in patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase. Eur J Clin Pharmacol. 2012 May;68(5):723-33. doi: 10.1007/s00228-011-1200-7. Epub 2011 Dec 30.
PMID: 22207416DERIVEDKantarjian HM, Hochhaus A, Saglio G, De Souza C, Flinn IW, Stenke L, Goh YT, Rosti G, Nakamae H, Gallagher NJ, Hoenekopp A, Blakesley RE, Larson RA, Hughes TP. Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. Lancet Oncol. 2011 Sep;12(9):841-51. doi: 10.1016/S1470-2045(11)70201-7. Epub 2011 Aug 17.
PMID: 21856226DERIVEDCortes JE, Hochhaus A, le Coutre PD, Rosti G, Pinilla-Ibarz J, Jabbour E, Gillis K, Woodman RC, Blakesley RE, Giles FJ, Kantarjian HM, Baccarani M. Minimal cross-intolerance with nilotinib in patients with chronic myeloid leukemia in chronic or accelerated phase who are intolerant to imatinib. Blood. 2011 May 26;117(21):5600-6. doi: 10.1182/blood-2010-11-318949. Epub 2011 Apr 5.
PMID: 21467546DERIVEDSaglio G, Kim DW, Issaragrisil S, le Coutre P, Etienne G, Lobo C, Pasquini R, Clark RE, Hochhaus A, Hughes TP, Gallagher N, Hoenekopp A, Dong M, Haque A, Larson RA, Kantarjian HM; ENESTnd Investigators. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2251-9. doi: 10.1056/NEJMoa0912614. Epub 2010 Jun 5.
PMID: 20525993DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2007
First Posted
May 10, 2007
Study Start
July 31, 2007
Primary Completion
September 2, 2009
Study Completion
August 21, 2019
Last Updated
November 18, 2020
Results First Posted
June 17, 2013
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com