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

NCT ID NCT01698905

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

First seen Jun 26, 2026 · Last updated Jun 26, 2026

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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, Attica, 106 76, Greece

  • Novartis Investigative Site

    Larissa, GR, 411 10, Greece

  • Novartis Investigative Site

    Athens, 18547, 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, 464 8681, Japan

  • Novartis Investigative Site

    Narita, Chiba, 286-8523, Japan

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582, Japan

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-0011, Japan

  • Novartis Investigative Site

    Akita, 010-8543, Japan

  • Novartis Investigative Site

    Aomori, 030 8553, Japan

  • Novartis Investigative Site

    Chiba, 2608677, 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, Seocho Gu, 06591, South Korea

  • Novartis Investigative Site

    Seville, Andalusia, 41013, Spain

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    Badalona, Catalonia, 08916, 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

    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