Can a second stop be successful? nilotinib trial for CML relapse

NCT ID NCT02917720

Ongoing Disease control Sponsor: European LeukemiaNet Source: ClinicalTrials.gov ↗

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

Summary

This study looks at whether taking nilotinib for two years can help people with chronic myeloid leukemia (CML) stay in remission after stopping their medication a second or third time. About 75 adults who previously tried and failed to stop treatment will take nilotinib and then attempt to stop again. The goal is to see if they can maintain a deep molecular remission for at least 12 months without restarting therapy.

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 offer a way for CML patients who relapsed after stopping treatment to safely stop again and remain in remission.
What could go wrong: This is a small Phase 2 trial with only 75 participants, so results may not apply to everyone. The treatment requires two years of nilotinib, and some patients may still relapse.

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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

Amsterdam UMC, locatie VUmc

Amsterdam, 1081 HV, Netherlands
Kliniken Ostalb, Stauferklinikum Schwäbisch Gmünd

Mutlangen, 73557, Germany
Klinikum Bayreuth

Bayreuth, 95445, Germany
Klinikum Chemnitz

Chemnitz, 09113, Germany
Klinikum der Philipps-Universität

Marburg, 35033, Germany
Klinikum rechts der Isar

München, Bavaria, 81675, Germany
Medizinische Hochschule Hannover

Hannover, North Rhine-Westphalia, 30625, Germany
Onkologische Schwerpunktpraxis

Esslingen am Neckar, 73728, Germany
Schwarzwald-Baar Klinikum

Villingen-Schwenningen, 78052, Germany
Schwerpunktpraxis Onkologie

Heilbronn, 74072, Germany
Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79108, Germany
Universitätsklinikum Halle (Saale)

Halle, Germany
Universitätsklinikum Rostock

Rostock, 18057, Germany
Universitätsklinikum der RWTH

Aachen, 52074, Germany
Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

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