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Leukemia drug holiday: can patients stop nilotinib and stay Cancer-Free?

NCT ID NCT01698905

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study looked at whether people with chronic myeloid leukemia (CML) who had very low levels of cancer cells could safely stop taking the drug nilotinib (Tasigna). Participants had already been treated with imatinib (Gleevec) and then nilotinib for at least 3 years. The main goal was to see how many could stay in remission without restarting nilotinib for 48 weeks. The trial enrolled 163 adults and followed them for up to 10 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nilotinib (Tasigna)
What this could lead to
If successful, this could allow some CML patients to stop daily medication and remain in remission, improving quality of life.
What could go wrong
This is a single-arm phase 2 trial with 163 patients, so results may not apply to everyone. Some patients may relapse and need to restart treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

163 people

The number who actually took part.

Started

Dec 2012

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic myeloid leukemia

Contacts and locations

Locations

  • Compass Oncology

    Vancouver, Washington, 98683, United States

  • Indiana Blood and Marrow Institute

    Beech Grove, Indiana, 46107, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1221ADC, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1114AAN, Argentina

  • Novartis Investigative Site

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    Box Hill, Victoria, 3128, Australia

  • Novartis Investigative Site

    Antwerp, 2060, Belgium

  • Novartis Investigative Site

    Goiânia, Goiás, 74605-050, Brazil

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20211-030, Brazil

  • Novartis Investigative Site

    Rio de Janiero, Rio de Janeiro, 20231-050, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

  • Novartis Investigative Site

    Campinas, São Paulo, 13083-970, Brazil

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 5C2, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4, Canada

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4, Canada

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Strasbourg, 67085, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511, France

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Heilbronn, 74072, Germany

  • Novartis Investigative Site

    Potsdam, 14467, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Athens, 106 76, Greece

  • Novartis Investigative Site

    Athens, 185 47, Greece

  • Novartis Investigative Site

    Larissa, 411 10, Greece

  • Novartis Investigative Site

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4648681, Japan

  • Novartis Investigative Site

    Narita, Chiba, 286-8523, Japan

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-0011, Japan

  • Novartis Investigative Site

    Akita, 0108543, Japan

  • Novartis Investigative Site

    Aomori, 0308553, Japan

  • Novartis Investigative Site

    Chiba, 2608677, Japan

  • Novartis Investigative Site

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64718, Mexico

  • Novartis Investigative Site

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Novartis Investigative Site

    Gdansk, 80-952, Poland

  • Novartis Investigative Site

    Warsaw, 00-791, Poland

  • Novartis Investigative Site

    Moscow, 125167, Russia

  • Novartis Investigative Site

    Saint Petersburg, 191024, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197341, Russia

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

  • Novartis Investigative Site

    Alicante, 03010, Spain

  • Novartis Investigative Site

    Madrid, 28006, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Madrid, 28046, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Liverpool, L7 8XP, United Kingdom

  • Novartis Investigative Site

    Nottingham, NG5 1PB, United Kingdom

  • St Agnes Hospital

    Baltimore, Maryland, 21229, United States

  • USC Kenneth Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0144, United States

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