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 Aug 14, 2026 · Updated 4 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.

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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
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Vienna, A-1130, Austria
Novartis Investigative Site

Sint-Niklaas, Oost Vlaanderen, 9100, Belgium
Novartis Investigative Site

Kortrijk, West-Vlaanderen, 8500, Belgium
Novartis Investigative Site

Brussels, 1090, Belgium
Novartis Investigative Site

Brussels, 1200, Belgium
Novartis Investigative Site

Charleroi, 6000, Belgium
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Ghent, 9000, Belgium
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Liège, 4000, Belgium
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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 Jarez, Pays de la Loire Region, 42270, France
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Bordeaux, 33076, France
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Brest, 29609, France
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Corbeil-Essonnes, 91100, France
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Dunkirk, 59240, France
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Grenoble, 38043, France
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Nantes, 44093, France
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Rouen, 76038, France
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Strasbourg, 67000, France
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Strasbourg, 67085, France
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Toulouse, 31059, France
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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Mannheim, Baden-Wurttemberg, 68305, Germany
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Frankfurt am Main, Hesse, 60590, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Leipzig, Saxony, 04103, Germany
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Lübeck, Schleswig-Holstein, 23563, Germany
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Jena, Thuringia, 07740, Germany
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Aachen, 52074, Germany
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Bayreuth, 95445, Germany
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Berlin, 13353, Germany
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Bonn, 53105, Germany
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Bottrop, 46236, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40479, Germany
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Goslar, 38642, Germany
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Hamburg, 20246, Germany
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Hamburg, 22417, Germany
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Magdeburg, 39104, Germany
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Mainz, 55131, Germany
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Stuttgart, 70376, Germany
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Ulm, 89081, Germany
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Athens, 106 76, Greece
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Athens, 115 27, Greece
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Budapest, H-1083, Hungary
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Szeged, 6725, Hungary
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Dublin, D03 VX82, Ireland
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Galway, 12074, Ireland
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Ancona, AN, 60126, Italy
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Brescia, BS, 25123, Italy
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Cona, FE, 44124, Italy
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Florence, FI, 50134, Italy
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Genova, GE, 16132, Italy
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Nuoro, NU, 08100, Italy
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Perugia, PG, 06129, Italy
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Reggio Calabria, RC, 89124, Italy
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Roma, RM, 00161, Italy
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Orbassano, TO, 10043, Italy
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Terni, TR, 05100, Italy
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Naples, 80131, Italy
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Novara, 28100, Italy
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Kashiwa, Chiba, 277-8567, Japan
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Sapporo, Hokkaido, 060-8648, Japan
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Sagamihara, Kanagawa, 252-0375, Japan
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Kumamoto, Kumamoto, 860-8556, Japan
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Sakai, Osaka, 590-0197, Japan
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Suita, Osaka, 565-0871, Japan
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Saga, Saga-ken, 849-8501, Japan
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Kawagoe, Saitama, 3508550, Japan
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Shimotsuga Gun, Tochigi, 3210293, Japan
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Bunkyo-ku, Tokyo, 1138519, Japan
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Shinjuku Ku, Tokyo, 160-0023, Japan
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Akita, 0108543, Japan
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Groningen, 9713 GZ, Netherlands
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Gdansk, 80-952, Poland
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Warsaw, 02-172, Poland
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Terrassa, Catalonia, 08221, Spain
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Pamplona, Navarre, 31008, Spain
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Oviedo, Principality of Asturias, 33011, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
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Barakaldo, Vizcaya, 48903, Spain
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Barcelona, 08041, Spain
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Las Palmas de Gran Canaria, 35010, Spain
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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
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Ourense, 32005, Spain
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Tarragona, 43005, Spain
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Lund, SE-221 85, Sweden
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Stockholm, SE-171 76, Sweden
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Uppsala, SE-751 85, Sweden
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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

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