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Leukemia drug holiday: study tests if patients can pause nilotinib

NCT ID NCT01784068

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

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study looked at whether people with chronic myeloid leukemia (CML) who have done very well on the drug nilotinib can safely stop taking it. 215 patients who had been on nilotinib for at least two years and had very low levels of cancer cells were enrolled. The main goal was to see how many could stay in remission without the drug for 48 weeks. The results help doctors understand who might be able to take a break from treatment.

What this could mean

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

Active substance

nilotinib

What this could lead to

If successful, this could allow some CML patients to stop daily medication and remain in remission, reducing long-term drug side effects and improving quality of life.

What could go wrong

This is a phase 2 study with 215 patients, so results are not definitive. Not all patients maintained remission, and those who relapsed needed to restart treatment. Long-term safety of stopping therapy is still being studied.

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 MYELOGENOUS LEUKEMIA

Contacts and locations

Locations

  • Cancer Center of Kansas

    Wichita, Kansas, 67214-3728, United States

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605, United States

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901, United States

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Lakes Research

    Miami Lakes, Florida, 33014, United States

  • Memorial Sloan Kettering

    New York, New York, 10017, United States

  • Novartis Investigative Site

    Buenos Aires, C1114AAN, Argentina

  • Novartis Investigative Site

    Graz, 8036, Austria

  • Novartis Investigative Site

    Rankweil, A-6830, Austria

  • Novartis Investigative Site

    Salzburg, 5020, Austria

  • Novartis Investigative Site

    Vienna, 1140, Austria

  • Novartis Investigative Site

    Vienna, A-1130, Austria

  • Novartis Investigative Site

    Sint-Niklaas, Oost Vlaanderen, 9100, Belgium

  • Novartis Investigative Site

    Brussels, 1090, Belgium

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Charleroi, 6000, Belgium

  • Novartis Investigative Site

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    Kortrijk, 8500, Belgium

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Varna, 9000, Bulgaria

  • Novartis Investigative Site

    Bogota, Cundinamarca, 111411, Colombia

  • Novartis Investigative Site

    Montería, 230004, Colombia

  • Novartis Investigative Site

    Aarhus N, 8200, Denmark

  • Novartis Investigative Site

    Bayonne, Bayonne Cedex, 64109, France

  • Novartis Investigative Site

    Saint Priest En Jarez, Pays de la Loire Region, 42270, France

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Brest, 29609, France

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100, France

  • Novartis Investigative Site

    Dunkirk, 59240, France

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Rouen, 76038, France

  • Novartis Investigative Site

    Strasbourg, 67000, France

  • Novartis Investigative Site

    Strasbourg, 67085, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Lübeck, Schleswig-Holstein, 23563, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Aachen, 52074, Germany

  • Novartis Investigative Site

    Bayreuth, 95445, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Bonn, 53105, Germany

  • Novartis Investigative Site

    Bottrop, 46236, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Düsseldorf, 40479, Germany

  • Novartis Investigative Site

    Goslar, 38642, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Hamburg, 22417, Germany

  • Novartis Investigative Site

    Magdeburg, 39104, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Stuttgart, 70376, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Athens, 106 76, Greece

  • Novartis Investigative Site

    Athens, 115 27, Greece

  • Novartis Investigative Site

    Budapest, H-1083, Hungary

  • Novartis Investigative Site

    Szeged, 6720, Hungary

  • Novartis Investigative Site

    Dublin, D03 VX82, Ireland

  • Novartis Investigative Site

    Galway, 12074, Ireland

  • Novartis Investigative Site

    Ancona, AN, 60126, Italy

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    Cona, FE, 44100, Italy

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Nuoro, NU, 08100, Italy

  • Novartis Investigative Site

    Perugia, PG, 06129, Italy

  • Novartis Investigative Site

    Reggio Calabria, RC, 89100, Italy

  • Novartis Investigative Site

    Roma, RM, 00161, Italy

  • Novartis Investigative Site

    Orbassano, TO, 10043, Italy

  • Novartis Investigative Site

    Terni, TR, 05100, Italy

  • Novartis Investigative Site

    Naples, 80132, Italy

  • Novartis Investigative Site

    Novara, 28100, Italy

  • Novartis Investigative Site

    Kashiwa, Chiba, 277-8567, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060 8648, Japan

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 252-0375, Japan

  • Novartis Investigative Site

    Ōsaka-sayama, Osaka, 589 8511, Japan

  • Novartis Investigative Site

    Suita, Osaka, 565 0871, Japan

  • Novartis Investigative Site

    Saga, Saga-ken, 849-8501, Japan

  • Novartis Investigative Site

    Kawagoe, Saitama, 350 8550, Japan

  • Novartis Investigative Site

    Shimotsuga Gun, Tochigi, 321-0293, Japan

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 160-0023, Japan

  • Novartis Investigative Site

    Akita, 010-8543, Japan

  • Novartis Investigative Site

    Kumamoto, 860-8556, Japan

  • Novartis Investigative Site

    Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    Gdansk, 80-952, Poland

  • Novartis Investigative Site

    Warsaw, 02 106, Poland

  • Novartis Investigative Site

    Terrassa, Catalonia, 08221, Spain

  • Novartis Investigative Site

    Ourense, Galicia, 32005, Spain

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33011, Spain

  • Novartis Investigative Site

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

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, 35010, Spain

  • Novartis Investigative Site

    Madrid, 28006, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Madrid, 28046, Spain

  • Novartis Investigative Site

    Tarragona, 43005, Spain

  • Novartis Investigative Site

    Lund, SE-221 85, Sweden

  • Novartis Investigative Site

    Stockholm, SE-171 76, Sweden

  • Novartis Investigative Site

    Uppsala, SE-751 85, Sweden

  • Novartis Investigative Site

    Cardiff, CF14 4XW, United Kingdom

  • Novartis Investigative Site

    Oxford, OX3 7LE, United Kingdom

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Tennessee Oncology PLLC

    Chattanooga, Tennessee, 37404, United States