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

NCT ID NCT02917720

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

75 people

The number who actually took part.

Started

Sep 2016

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Patients with Ph chromosome and/or the BCR-ABL (either b3a2 and /or b2a2) fusion gene positive CML * CML in CP having failed a prior attempt to stop imatinib or other TKIs therapy either within EURO-SKI or not * Pretreatment at least one year with any TKI after 1st stop * Written informed consent Exclusion Criteria: * Previous hematological relapse after first stop of TKI. * Failure to any TKI at any time during CML treatment according to current ELN criteria * Previous planned or performed allo SCT * Previous AP/BC at any time in the history of the disease * High cardiac risk according to ESC score (≥ 10 Points) * Impaired cardiac function including any of the following: * Use of a ventricular paced pacemaker; congenital long QT syndrome or family history of; history or presence of significant ventricular or atrial tachyarrhythmias; clinically significant resting bradycardia (\<50 bpm); QTcF \>450 msec at baseline, myocardial infarction before baseline; other clinically significant heart disease (e.g., unstable angina, congestive heart failure, or uncontrolled hypertension). * Treatment with inhibitors of CYP3A4 or medications that have been well documented to prolong the QT interval is contraindicated. * History of acute pancreatitis within one year of study entry or medical history of chronic pancreatitis. * Positive hepatitis B virus serology test or HBV infection * Any other malignancy except if neither clinically significant nor requires active intervention. * Severe or uncontrolled medical conditions (i.e., uncontrolled diabetes, acute or chronic liver disease, pancreatic, or severe renal disease unrelated to tumor, active or uncontrolled infection). * Women who are pregnant, breast feeding, or of childbearing potential without a negative serum pregnancy test at baseline. Male or female patients of childbearing potential unwilling to use an effective barrier contraceptive method

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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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