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 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.

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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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