TriangleNCT01698905 · CITED IN SOURCE DOCUMENTS
Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2026-08-12
A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Participants in TFR Within 48-weeks Following Nilotinib Cessation
Percentage of Participants in TFR Within 96, 144, 192, 264 Weeks, and Within the End of Years 6, 7, 8, 9 and 10 Following Nilotinib Cessation
Progression Free Survival (PFS) After the Start of the TFR Phase
Treatment Free Survival (TFS) After the Start of the TFR Phase
Overall Survival (OS) After the Start of the TFR Phase
BCR-ABL Ratio (%) Over Time in Nilotinib Treatment Re-initiation Phase (NTRI)
Percentage of Participants With Stable MMR in Nilotinib Re-initiation Phase
Proportion of Participants With Stable MR4.5 in Nilotinib Re-initiation Phase
Percentage of Participants With Stable MR4 in Nilotinib Re-initiation Phase
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: 1. Male or female patients \>= 18 years of age 2. ECOG Performance Status of 0, 1, or 2 3. Patient with diagnosis of BCR-ABL positive CML CP 4. Patient has received a minimum of 3 years of tyrosine kinase inhibitor treatment (first with imatinib (\> 4 weeks) and then switched to nilotinib) since initial diagnosis 5. Patient has at least 2 years of nilotinib treatment prior to study entry. 6. Patient has achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening 7. Adequate end organ function as defined by: * Direct bilirubin ≤ 1.5 x ULN except for i) patient with documented Gilbert's syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range) * SGOT(AST) and SGPT(ALT) \< 3 x ULN (upper limit of normal) * Serum lipase ≤ 2 x ULN * Alkaline phosphatase ≤ 2.5 x ULN * Serum creatinine \< 1.5 x ULN 8. Patients must have the following electrolyte values ≥ LLN (lower limit of normal) limits or corrected to within normal limits with supplements prior to the first dose of study medication: * Potassium * Magnesium * Total calcium (corrected for serum albumin) 9. Patients must have normal marrow function as defined below: * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L * Platelets ≥ 100 x 109/L * Hemoglobin ≥ 9.0 g/dL 10. Written informed consent obtained prior to any screening procedures Exclusion Criteria: 1. Prior AP, BC or allo-transplant 2. Patient has documented MR4.5 at the time when switched from imatinib to nilotinib 3. Patients with known atypical transcript 4. CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if a testing was done in the past (there is no requirement to perform mutation testing at study entry if it was not done in the past) 5. Dose reductions due to neutropenia or thrombocytopenia in the past 6 months 6. Patient ever attempted to permanently discontinue imatinib or nilotinib treatment 7. Known impaired cardiac function including any one of the following: * Inability to determine the QT interval on ECG * Complete left bundle branch block * Long QT syndrome or a known family history of long QT syndrome * History of or presence of clinically significant ventricular or atrial tachyarrhythmias * Clinically significant resting bradycardia * QTcF \> 480 msec * History or clinical signs of myocardial infarction within 1 year prior to study entry * History of unstable angina within 1 year prior to study entry * Other clinically significant heart disease (e.g. uncontrolled congestive heart failure or uncontrolled hypertension) 8. Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes (defined as HbA1c \> 9%), uncontrolled infection) 9. History of acute pancreatitis within 1 year prior to study entry or past medical history of chronic pancreatitis 10. Known presence of a significant congenital or acquired bleeding disorder unrelated to cancer 11. History of other active malignancy within 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ treated curatively 12. Patients who have not recovered from prior surgery 13. Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks of Day 1 14. Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to study entry. See Appendix 14.1 for a list of these medications. This list may not be comprehensive. 15. Patients actively receiving therapy with herbal medicines that are strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to study entry. These herbal medicines may include Echinacea, (including E. purpurea, E. angustifolia and E. pallida), Piperine, Artemisinin, St. John's Wort, and Ginkgo. 16. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either safely discontinued or switched to a different medication prior to study entry. (Please see www.azcert.org/medical-pros/drug-lists/printable-drug-list.cfm for a list of agents that prolong the QT interval.) 17. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery) 18. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 19. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test before initiation of study treatment and must also use highly effective methods of contraception while enrolled in the study. The use of highly effective contraception should continue for at least 14 days after the last dose of study treatment or until the last day of TFR/TFR-2, or for the duration of a monthly cycle of oral contraception, whichever is longer. Acceptable forms of highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment * Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should be stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to enrolling. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. If a study patient becomes pregnant or is suspected of being pregnant during the study or within 30 days as part of safety evaluations after the final dose of nilotinib, the Study Doctor needs to be informed immediately and any ongoing study treatment with nilotinib has to be stopped immediately.
- healthy Volunteers
- false
- maximum Age
- 100 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
- intervention Names
- Drug: nilotinib
- label
- Nilotinib
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Nilotinib
- description
- Nilotinib was dosed by weight or body surface area. Nilotinib 300 mg BID or 400 mg BID was be administered orally at approximately 12 hour intervals, and must not have been taken with food. The capsules were to be swallowed whole with water. No food should have been consumed for at least 2 hours before the dose was taken and no additional food should have been consumed for at least one hour after the dose was taken. Patients were also allowed to enter this study on the same dose they were taking prior to study entry. Patients who required permanent dose reduction from their original starting dose were to be allowed to enter this study on the same dose only if the patient maintained this dose for a minimum of 6 months prior to study entry.
- name
- nilotinib
- other Names
- AMN107
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 163
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation.
- measure
- Percentage of Participants in TFR Within 48-weeks Following Nilotinib Cessation
- time Frame
- first 48 weeks following nilotinib cessation
- secondary Outcomes
- description
- TFR is defined as no confirmed loss of MR4 (molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation.
- measure
- Percentage of Participants in TFR Within 96, 144, 192, 264 Weeks, and Within the End of Years 6, 7, 8, 9 and 10 Following Nilotinib Cessation
- time Frame
- first 96, 144, 192, 264 weeks, and within the end of years 6, 7, 8, 9 and 10 following nilotinib cessation.
- description
- Progression free survival, defined as the time from the date of start of TFR to the date of event defined as the first occurrence of documented disease progression to Accelerated phase/Blast Crises (AP/BC) or the date of death from any cause.
- measure
- Progression Free Survival (PFS) After the Start of the TFR Phase
- time Frame
- nilotinib cessation up to approximately 580 weeks
- description
- Treatment-free survival defined as the time from the date of start of TFR to the date of earliest occurrence of any of the following events: loss of MMR, confirmed loss of MR4, re-initiation of nilotinib treatment due to any cause, progression to acute phase (AP) or blast crisis (BC) or death due to any cause.
- measure
- Treatment Free Survival (TFS) After the Start of the TFR Phase
- time Frame
- nilotinib cessation up to approximately 580 weeks
- description
- Overall survival, defined as the time from start date of TFR (date of entering the TFR phase) to date of death due to any cause at any time during the study, including the follow-up period after discontinuation of study up to LPLV. If a patient is not known to have died, survival will be censored at the date of last contact.
- measure
- Overall Survival (OS) After the Start of the TFR Phase
- time Frame
- nilotinib cessation up to approximately 580 weeks
- description
- ABL= Abelson leukemia virus and BCR=Break point cluster region. The BCR-ABL ratio (%) represents the level of BCR-ABL fusion gene transcripts relative to a control gene (ABL) measured in peripheral blood samples using quantitative reverse transcription polymerase chain reaction (RT-PCR). Results are expressed as a percentage on the International Scale (IS), a standardized reporting method that allows comparison across laboratories. The BCR-ABL ratio is used to assess the molecular response to treatment, with lower values indicating a reduced disease burden.
- measure
- BCR-ABL Ratio (%) Over Time in Nilotinib Treatment Re-initiation Phase (NTRI)
- time Frame
- re-start of nilotinib up to approximately 48 weeks
- description
- Percentage of participants who were in stable MMR (stable MMR=BCR-ABL ≤ 0.1% IS) at multiple timepoints after achievement of that response in the nilotinib re-initiation phase for those timepoints.
- measure
- Percentage of Participants With Stable MMR in Nilotinib Re-initiation Phase
- time Frame
- at 48 weeks, 96 weeks, 144 weeks, 192 weeks, 240 weeks, 288 weeks, 336 weeks, 384 weeks and 432 weeks after re-initiating Nilotinib in the NTRI Phase
- description
- Percentage of participants who were in stable MR4.5 (stable MR4.5=BCR-ABL ≤ 0.0032% IS) at multiple time points after achievement of that response in the nilotinib re-initiation phase for those timepoints.
- measure
- Proportion of Participants With Stable MR4.5 in Nilotinib Re-initiation Phase
- time Frame
- at 48 weeks, 96 weeks, 144 weeks, 192 weeks, 240 weeks, 288 weeks, 336 weeks, 384 weeks and 432 weeks
- description
- Percentage of participants who were in stable MR4 (stable MR4=BCR-ABL ≤ 0.01% IS) at multiple timepoints after achievement of that response in the nilotinib re-initiation phase for those timepoints.
- measure
- Percentage of Participants With Stable MR4 in Nilotinib Re-initiation Phase
- time Frame
- at 48 weeks, 96 weeks, 144 weeks, 192 weeks, 240 weeks, 288 weeks, 336 weeks, 384 weeks and 432 weeks
Full study description
- brief Summary
- A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.
- detailed Description
- The Primary objective was to evaluate the percentage of patients in TFR within 48 weeks following nilotinib cessation. This study originally consisted of seven phases (five treatment phases and two treatment-free phases) from which two were the focus of this primary analysis report (consolidation, TFR and treatment re-initiation) The study consisted of 2 main phases: Consolidation and TFR Nilotinib treatment consolidation phase (NTCS): Patients who satisfied all inclusion/exclusion criteria were enrolled in the consolidation phase and continued to receive nilotinib for 52 weeks at the dose which the patient was receiving prior to study entry. If a patient maintained MR4.5 throughout the consolidation phase, he/she was eligible to enter in the TFR phase. If a patient had confirmed loss of MR4.5 during the consolidation phase, he/she was not eligible to enter in the TFR phase and continued nilotinib treatment. Nilotinib TFR phase: Patients who were eligible to enter in the TFR phase after completing the 52 week consolidation phase stopped taking nilotinib on the first day of the TFR phase. Duration of this phase was up to 520 weeks after the last patient enters in the TFR phase. Nilotinib treatment re-initiation phase (NTRI): If a patient had a confirmed loss of MR4 (two consecutive BCR-ABL \>0.01% IS) or loss of MMR (BCR-ABL \>0.1% IS) in the TFR phase, the patient restarted nilotinib treatment. Patients will be on nilotinib treatment for up to 520 weeks after the last patient entered the nilotinib TFR phase, or until a patient experience unacceptable toxicity, disease progression and/or treatment discontinued at the discretion of the Investigator or if the patient withdrew consent. Nilotinib cessation was not attempted for a second time in the patient who reinitiated treatment or discontinued following the TFR phase. Nilotinib treatment continuation phase (NTCT) and Nilotinib treatment prolonged continuation phase (NTCT-P): Patients who were not eligible to enter into the TFR phase after completing the 52-week NTCS phase entered the nilotinib treatment continuation (NTCT) phase and would continue treatment with nilotinib for another 52 weeks (a total of 104 weeks of treatment). Patients who were not able to maintain MR4.5 and had a confirmed loss of MR4.5 during the NTCT phase were not eligible to enter the TFR-2 phase. These patients entered into the nilotinib prolonged treatment continuation phase (NTCT-P) and continued nilotinib treatment until 520 weeks after the last patient entered the nilotinib TFR phase, or until the patients experience unacceptable toxicity, disease progression and/or treatment would be discontinued at the discretion of the Investigator or withdrawal of consent. Nilotinib TFR-2 phase: Patients who maintained MR4.5 during the NTCT phase were eligible to cease nilotinib treatment and enter the TFR-2 phase. The duration of the nilotinib TFR-2 phase is up to 520 weeks after the last patient entered the TFR phase. Patients stopped taking nilotinib therapy on the day they entered the TFR-2 phase. Nilotinib treatment re-initiation-2 (NTRI-2): If a patient had a loss of MMR or a confirmed loss of MR4 during the TFR-2 phase, he/she entered the nilotinib treatment re-initiation-2 (NTRI-2) phase and resumed nilotinib treatment at a dose of either 300 mg or 400 mg bid. Safety follow-up was performed within 30 days after the last dose of study treatment or the last day in TFR/TFR-2. Post-treatment follow-up visits were performed every 12 weeks up to 520 weeks after the last patient entered the nilotinib TFR phase.
Source references
- references
- citation
- Mahon FX, Boquimpani C, Kim DW, Benyamini N, Clementino NCD, Shuvaev V, Ailawadhi S, Lipton JH, Turkina AG, De Paz R, Moiraghi B, Nicolini FE, Dengler J, Sacha T, Takahashi N, Fellague-Chebra R, Acharya S, Wong S, Jin Y, Hughes TP. Treatment-Free Remission After Second-Line Nilotinib Treatment in Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Single-Group, Phase 2, Open-Label Study. Ann Intern Med. 2018 Apr 3;168(7):461-470. doi: 10.7326/M17-1094. Epub 2018 Feb 20.
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Preserved source evidence · Not medical advice