An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment
MACS0999
1 other identifier
interventional
52
2 countries
23
Brief Summary
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2009
Typical duration for phase_4
23 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
September 16, 2009
CompletedFirst Posted
Study publicly available on registry
September 18, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
July 1, 2021
CompletedJuly 1, 2021
June 1, 2021
3 years
September 16, 2009
April 28, 2021
June 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3
A patient was considered improved if 50% or more of the chronic imatinib-related chronic low grade nonhematologic AEs showed improvement (a decrease in CTCAE \[Common Terminology Criteria for Adverse Events\] grade or complete resolution).
End of Cycles 1, 2, and 3
Secondary Outcomes (8)
Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline
Cycles 1, 2, 6, 9, and 12
Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline
Cycles 1,2,3,6,9,12
Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy
Cycles 1,2,3,6,9, and 12
Duration of Complete Cytogenetic Response
18 months of follow up from the first documented response
Time to Complete Cytogenetic Response in Participants Not Reporting at Baseline
Cycle 12
- +3 more secondary outcomes
Study Arms (1)
nilotinib
EXPERIMENTALParticipants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
Interventions
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
Eligibility Criteria
You may qualify if:
- Male or female patients ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
- Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)
- Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol
- CML-CP patients initiated on any dose of imatinib
- Ability to provide written informed consent prior to any study related screening procedures being done
You may not qualify if:
- Loss of CHR or cytogenetic response
- Prior accelerated phase or blast phase CML
- Previously documented T315I mutation
- Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
- Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
- Treatment with other investigational agents within 30 days of Day 1.
- History of non-compliance to medical regimens or inability to grant consent.
- Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Hematology Oncology Services of Arkansas SC
Little Rock, Arkansas, 72205, United States
USC Norris Cancer Center LAC & USC Medical Center
Los Angeles, California, 90033, United States
Southwest Cancer Care Murrieta
Poway, California, 92064, United States
Rocky Mountain Cancer Centers RMCC - Aurora
Greenwood Village, Colorado, United States
Florida Cancer Institute
New Port Richey, Florida, 34655, United States
Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4
Ocoee, Florida, *see dep*, United States
Stroger Cook County Hospital John H. Stroger Hospital
Chicago, Illinois, 60612, United States
St. Francis Hospital and Health Centers IndianaBlood&MarrowTransplantn
Beech Grove, Indiana, 46107, United States
St. Agnes Hospital
Baltimore, Maryland, 21229, United States
St. Louis University Cancer Center
St Louis, Missouri, 63110, United States
Northwest Cancer Specialists Salmon Creek Office
Portland, Oregon, 97210, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp
Dallas, Texas, 75231, United States
Texas Oncology Texas Oncology - Sugar Land
Dallas, Texas, 75246, United States
MD Anderson Cancer Center/University of Texas
Houston, Texas, 77031, United States
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
San Antonio, Texas, 78229, United States
Novartis Investigative Site
Brampton, Ontario, L6R 3J7, Canada
Novartis Investigative Site
Toronto, Ontario, M5G 2M9, Canada
Novartis Investigative Site
Montreal, Quebec, H1T 2M4, Canada
Novartis Investigative Site
Montreal, Quebec, H3A 1A1, Canada
Related Publications (1)
Cortes JE, Lipton JH, Miller CB, Busque L, Akard LP, Pinilla-Ibarz J, Keir C, Warsi G, Lin FP, Mauro MJ. Evaluating the Impact of a Switch to Nilotinib on Imatinib-Related Chronic Low-Grade Adverse Events in Patients With CML-CP: The ENRICH Study. Clin Lymphoma Myeloma Leuk. 2016 May;16(5):286-96. doi: 10.1016/j.clml.2016.02.002. Epub 2016 Feb 16.
PMID: 26993758DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition 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
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2009
First Posted
September 18, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 1, 2021
Results First Posted
July 1, 2021
Record last verified: 2021-06