CMLPhase 2ENESTgoalNCT01744665
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
A Phase 2 study testing nilotinib in people with CML, run by Novartis Pharmaceuticals at 54 sites in United States.
Trial summary
To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CML
- What is being tested?
- nilotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 54 sitesUnited States
- Study dates
- 12 Aug 2013to 29 Sep 2018
- Phase
- Phase 2
- 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
- diagnosis of CML
- Treated with at least 1 year of imatinib
- Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by PCR reported on the International scale confirmed during screening
- Written informed consent obtained prior to any screening procedures performed
Who cannot join
- T315I mutation
- Prior imatinib failure or had accelerated phase or blast crisis CML
- Impaired cardiac function
- Pregnant or lactating women
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
Hendrick Cancer Center Hendricks Cancer Center
Abilene, Texas, 79601
Billings Clinic Billings Clinic (8)
Billings Montana, Montana, 59101
University of Alabama Comprehensive Cancer Center University of Alabama (8)
Birmingham, Alabama, 35294
Rocky Mountain Cancer Centers USOR
Boulder, Colorado, 80304
University of Virginia
Charlottesville, Virginia, 22908
Stroger Cook County Hospital Division of Hematology & Onc
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
University of South Carolina-Hollings Cancer Center Medical University of SC
Columbia, South Carolina, 29203
Ohio State Comprehensive Cancer Center/James Cancer Hospital OSU Medical Center
Columbus, Ohio, 43210
Texas Oncology Texas Oncology - McAllen
Dallas, Texas, 75246
Texas Oncology Texas Oncology - Plano West
Dallas, Texas, 75246
Texas Oncology P A Texas Oncology - Midland
Dallas, Texas, 75251
City of Hope National Medical Center Dept of Oncology
Duarte, California, 91010 3000
Duke University Medical Center Duke University Med Ctr
Durham, North Carolina, 27710
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Florida Cancer Specialists DeptofFloridaCancerSpecialists
Fort Myers, Florida, 33901
Compassionate Care Research Group Inc CCCMG
Fountain Valley, California, 92708
University of Texas Medical Branch SC
Galveston, Texas, 77555-1188
Banner MD Anderson Cancer Center Banner MD Anderson (2)
Gilbert, Arizona, 85234
Hackensack University Medical Center John Theurer Cancer Center
Hackensack, New Jersey, 07601
Carolina Oncology Specialists, PC
Hickory, North Carolina, 28602
Oncology Consultants Oncology Consultants, P.A.
Houston, Texas, 77024
The Methodist Hospital Cornell University
Houston, Texas, 77030
University of Iowa Hospitals and Clinics Holden Comprehensive Cancer Ct
Iowa City, Iowa, 52242
University of Kansas Hospital and Medical Center Clinical Research Center
Kansas City, Kansas, 66160
Kadlec Clinic Hematology and Oncology SC
Kennewick, Washington, 99336
UC San Diego UC San Diego Cancer Ctr
La Jolla, California, 92093-0987
Michigan State University / Breslin Cancer Center Breslin Cancer Center (3)
Lansing, Michigan
South Texas Cancer Center- McAllen
McAllen, Texas, 78503
Medical College of Wisconsin Med College of WI
Milwaukee, Wisconsin, 53226
West Virginia University/ Mary Babb Randolph Cancer Center Mary Babb Randolph Cancer Ctr
Morgantown, West Virginia, 26506
Hematology Oncology Associates of Northern New Jersey PA Dept of Hem-Onc of Northern NJ
Morristown, New Jersey, 07962
Wilshire Oncology Medical Group Corona Cancer Center
Multiple Locations, California
Tennessee Oncology Dept. of Centennial Medical
Nashville, Tennessee, 37203
Vanderbilt Univeristy Ingram Cancer Center (10)
Nashville, Tennessee, 37232
Memorial Sloan Kettering Memorial Sloan Kettering (63)
New York, New York, 10017
Weill Cornell Medical Center Dept. of Oncology
New York, New York, 10021
Columbia University Medical Center Herbert Irving Pavilion
New York, New York, 10032
MD Anderson Cancer Center - Orlando Cancer Center
Orlando, Florida, 32806
Epic-Care
Pleasant Hill, California, 94523
Northwest Cancer Specialists Compass Oncology -BKM
Portland, Oregon, 97210
University of Rochester Medical Center
Rochester, New York, 14642
Sutter Institute for Medical Research Oncology/Hematology
Sacramento, California, 95816-5199
University of Utah / Huntsman Cancer Institute Huntsman Cancer Center
Salt Lake City, Utah, 84103
Brooke Army Medical Center Brooke Army Medical
San Antonio, Texas, 78234
St Joseph Heritage Healthcare
Santa Rosa, California, 94503
Scottsdale Healthcare/TGen Clinical Research Service SC
Scottsdale, Arizona, 85258
Christus Schumpert Health System
Shreveport, Louisiana, 71101
H Lee Moffitt Cancer Center and Research Institute H. Lee Moffitt Cancer Ctr (67)
Tampa, Florida, 33612
Montefiore Medical Center Montefiore Medicial Center
The Bronx, New York, 10467
Westchester Medical Center NY Medical College
Valhalla, New York, 10595
Waco Cancer and Research Center
Waco, Texas, 76712
Cancer Center of Kansas
Wichita, Kansas, 67214-3728
Wake Forest University Health Sciences Hematology and Oncology
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase II Randomized, Multicenter Study of Treatment-free Remission in Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Patients Who Achieve and Sustain MR4.5 After Switching to Nilotinib
To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5
Read the detailed description
Study protocol included criteria for study termination that was met when > 2 patients lost CCyR during TFR phase (> 1% BCR-ABL); This study was terminated early as > 2 cases of confirmed loss of complete cytogenetic response were reported despite BCR-ABL monitoring during the TFR Phase. All cases achieved MR4.5 after Nilotinib treatment re-initiation and maintained until end of study; trial did not mandate re-initiation within 4 weeks after loss of MMR_ that was a requirement in other Nilotinib TFR trials Initial sample size was 300 patients with CML-CP; Amendment #2 in June 2015 reduced sample size to 59 due to recruitment challenges; Study endpoint analysis and interpretations of data were challenging due to small sample size for early study closure..
- Conditions
- CML
- Being tested
- nilotinib
- Keywords
- CML, chronic myeloid leukemia, stop, niotinib, discontinue, imatinib, switch, MR4.5, undetectable, bcr-abl
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nilotinibDrug
Also called AMN107
Nilotinib will be provided as 150 mg capsules. Patients will take nilotinib 300mg twice daily on study and dose modifications to 450mg once daily is permitted per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Free Remission | Experimental | Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase. Receives: Drug: nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Without Molecular Relapse Within 6 Months After Starting the TFR Phase
Percentage of particpants without confirmed loss of MMR within 6 months following nilotinib TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, in the first 6 months after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase. Molecular relapse is defined as having a confirmed BCR-ABL ratio above MMR (2 consecutive BCR-ABL levels >0.1% IS taken approximately 4 weeks apart).
Measured: 6 months after stopping nilotinib therapy
Secondary outcomes (13)
Relapse Free Survival is Defined as Time From the Date of Nilotinib Treatment Discontinuation to the First Documented Molecular Relapse (Confirmed Loss of MR4.5).
Relapse-free survival after the start of the TFR phase was summarized using the product-limit (Kaplan-Meier) estimates. The median for the relapse free survival and its 95% confidence intervals were provided. This analysis was performed on the FAS. Patients who dropped out without relapse were treated as censored observations.
Measured: 7 years
Percentage of Participants Without Molecular Relapse Within 12 and 24 Months After Starting the Treatment -Free Remission (TFR) Phase
The percentage of participants without confirmed loss of MRR at 12 and 24 months is calculated by dividing the number of patients with no documented confirmed loss of MR4 at 12 and 24 months after starting the nilotinib TFR phase by the number of patients who entered nilotinib TFR phase.
Measured: 12 and 24 months after starting the TFR
Percentage of Participants Who Regained MR4.5 After Restarting Nilotinib Due to Molecular Relapse
The percentage of participants who regained MR4.5 after restarting nilotinib will be calculated as the number of patients who achieved MR4.5 after having lost MR4 divided by the number of patients who lost MR4.
Measured: Restart of nilotinib up to month 6, 12 and 24
Number of Participants Who Progressed to Accelerated Phase/Blastic Crisis (AP/BC) or Died From From Any Cause.
Progression to AP/BC and death where the "failure" event is the earliest occurrence of the following event: progression to AP/BC date.
Measured: Baseline up to approximately 5 years
Overall Survival (OS)
OS was defined as the time from the date of cessation of nilotinib therapy to the date of death from any cause.
Measured: Baseline up to approximately 5 years
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
The M.D. Anderson Symptom Inventory for CML patients (MDASI-CML) was used to assess the nature and impact of symptom burden on life. It consisted of 20 validated symptom items and 6 validated interference items. Each item was assessed on an 11 point scale with responses from 0-10, 0=not present and 10=as bad as you can imagine. Symptom score (SS) was calculated when a patient scored at least 8 items of the symptom items using the formula: (sum of scores for the items answered) / number of items answered. If a subject responded to < 8 symptom items, the score was considered missing. Interference score (IS) was calculated when a patient scored at least 4 items using the formula: (sum of scores for the items answered)/number of items answered. If a subject responded to < 4 interference items, the score was considered missing. The total symptom score was 0-200 and total interference score was 0-60. Mean change from baseline was summarized at all post-baseline time points
Measured: From baseline to time to when MR4.5 is confirmed, up to 24 months, and from end of Consolidation Phase to 6 and 12 months into the TFR Phase
Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set
The EQ-5D-3L questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and visual analog has a scale 0 to 100 (0=worst imaginable health state, 100=best imaginable health state).
Measured: From baseline to time to when MR4.5, up to 24 months, is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR Phase
Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set
The SF-8 questionnaire consisted of 8 items (general health, physical functioning, role physical, bodily pain, vitality, social functioning, role-emotional and mental health) and was used to assess the impact of nilotinib treatment discontinuation on the quality of life. Each item had a 1 to 5 or 1 to 6 point response range and the higher number in the raw scores indicated poorer quality of life. The physical and mental component summary measures were calculated using a norm-based scoring method given in the instrument guidelines. These norm-based scores were summarized at baseline and mean change from baseline for post-baseline time points. The norm-based scores (based on the US population) had a mean of 50 and standard deviation of 10. Higher norm-based summary scores indicated better health
Measured: From baseline to time to when MR4.5 is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR Phase
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 3 in Consolidation Phase - Safety Set
The EuroQol Five Dimensional Three-level (EQ-5D-3L) questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point
Measured: At month 3 in Consolidation Phase
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Consolidation Phase - Safety Set
The EuroQol Five Dimensional Three-level (EQ-5D-3L) questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point
Measured: Month 12 in Consolidation Phase
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 24 in Consolidation Phase - Safety Set
The EuroQol Five Dimensional Three-level (EQ-5D-3L) questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point
Measured: Month 24 in Consolidation Phase
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 6 in Treatment Free Remission Phase - Safety Set
The EuroQol Five Dimensional Three-level questionnaire (EQ-5D-3L) comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point
Measured: Month 6 in in Treatment Free Remission Phase
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Treatment Free Remission Phase - Safety Set
The EuroQol Five Dimensional Three-level questionnaire (EQ-5D-3L) comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point
Measured: Month 12 in in Treatment Free Remission Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study start12 Aug 2013
- Primary completion28 Sep 2018
- Study completion29 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CMLStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744665
- Sponsor's protocol ID
- CAMN107AUS37
- Acronym
- ENESTgoal
- Status last verified
- Feb 2020
- First submitted
- 5 Dec 2012
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Multicenter Study of Treatment-free Remission in Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Patients Who Achieve and Sustain MR4.5 After Switching to Nilotinib
- ClinicalTrials.gov ID
- NCT01744665
- Acronym / sponsor ID
- ENESTgoal / CAMN107AUS37
- Conditions
- CML
- Keywords
- CML, chronic myeloid leukemia, stop, niotinib, discontinue, imatinib, switch, MR4.5, undetectable, bcr-abl
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2013 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Posted 10 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5
Detailed description
Study protocol included criteria for study termination that was met when > 2 patients lost CCyR during TFR phase (> 1% BCR-ABL); This study was terminated early as > 2 cases of confirmed loss of complete cytogenetic response were reported despite BCR-ABL monitoring during the TFR Phase. All cases achieved MR4.5 after Nilotinib treatment re-initiation and maintained until end of study; trial did not mandate re-initiation within 4 weeks after loss of MMR_ that was a requirement in other Nilotinib TFR trials Initial sample size was 300 patients with CML-CP; Amendment #2 in June 2015 reduced sample size to 59 due to recruitment challenges; Study endpoint analysis and interpretations of data were challenging due to small sample size for early study closure..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Free Remission | Experimental | Drug: nilotinibPatients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of CML
- Treated with at least 1 year of imatinib
- Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by PCR reported on the International scale confirmed during screening
- Written informed consent obtained prior to any screening procedures performed
Key exclusion criteria (4 listed)
- T315I mutation
- Prior imatinib failure or had accelerated phase or blast crisis CML
- Impaired cardiac function
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nilotinibAlso: AMN107Nilotinib will be provided as 150 mg capsules. Patients will take nilotinib 300mg twice daily on study and dose modifications to 450mg once daily is permitted per protocol. | Drug | Treatment Free Remission |
Primary outcome
Percentage of Participants Without Molecular Relapse Within 6 Months After Starting the TFR Phase
Time frame: 6 months after stopping nilotinib therapy
Percentage of particpants without confirmed loss of MMR within 6 months following nilotinib TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, in the first 6 months after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase. Molecular relapse is defined as having a confirmed BCR-ABL ratio above MMR (2 consecutive BCR-ABL levels >0.1% IS taken approximately 4 weeks apart).
13 secondary outcomes
Relapse Free Survival is Defined as Time From the Date of Nilotinib Treatment Discontinuation to the First Documented Molecular Relapse (Confirmed Loss of MR4.5).
Time frame: 7 years
Percentage of Participants Without Molecular Relapse Within 12 and 24 Months After Starting the Treatment -Free Remission (TFR) Phase
Time frame: 12 and 24 months after starting the TFR
Percentage of Participants Who Regained MR4.5 After Restarting Nilotinib Due to Molecular Relapse
Time frame: Restart of nilotinib up to month 6, 12 and 24
Number of Participants Who Progressed to Accelerated Phase/Blastic Crisis (AP/BC) or Died From From Any Cause.
Time frame: Baseline up to approximately 5 years
Overall Survival (OS)
Time frame: Baseline up to approximately 5 years
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
Time frame: From baseline to time to when MR4.5 is confirmed, up to 24 months, and from end of Consolidation Phase to 6 and 12 months into the TFR Phase
Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set
Time frame: From baseline to time to when MR4.5, up to 24 months, is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR Phase
Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set
Time frame: From baseline to time to when MR4.5 is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR Phase
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 3 in Consolidation Phase - Safety Set
Time frame: At month 3 in Consolidation Phase
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Consolidation Phase - Safety Set
Time frame: Month 12 in Consolidation Phase
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 24 in Consolidation Phase - Safety Set
Time frame: Month 24 in Consolidation Phase
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 6 in Treatment Free Remission Phase - Safety Set
Time frame: Month 6 in in Treatment Free Remission Phase
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Treatment Free Remission Phase - Safety Set
Time frame: Month 12 in in Treatment Free Remission Phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nilotinib in people with CML, run by Novartis Pharmaceuticals at 54 sites in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Mar 2020). 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?
Percentage of Participants Without Molecular Relapse Within 6 Months After Starting the TFR Phase (time frame: 6 months after stopping nilotinib therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2020.