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New combo therapy shows promise in leukemia battle

NCT ID NCT02201459

Disease control Sponsor: Hospices Civils de Lyon 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a second drug (pegylated interferon) to the standard leukemia medication nilotinib helps people with newly diagnosed chronic myeloid leukemia (CML) achieve a deeper molecular response faster. About 200 adults under 65 with early-stage CML took part. The goal was to see if the combination leads to very low levels of cancer genes after one year of treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Aug 2014

Finished

Oct 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 years

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: * Male and female patients * CP-CML, positive Philadelphia chromosome or positive BCR-ABL (M-bcr transcript), diagnosed less than 3 months prior to study entry * Age of at least 18 years-old and less than 65 years * Patient for whom treatment with Nilotinib is expected * No other CML treatment except for hydroxyurea and/or anagrelide * No previous TKI treatment. * No previous treatment with IFN even for other purposes. * SGOT and SGPT \< 2.5 UNL * Serum creatinine \< 2 UNL * No planned allogeneic stem cell transplantation * Signed informed consent * ECOG score 0 to 2 Exclusion Criteria: * Contra-indication to IFN * Transcripts other than M-Bcr * Pregnancy, lactation * HIV positivity, chronic hepatitis B or C. * Prior or concurrent malignancy other than CML (exceptions to be mentioned) * History of arterial occlusive disease or (peripheral, carotids or severe coronary heart disease). * Permanent elevation of total cholesterol and triglycerides despite treatment * Severe psychiatric/neurological disease (previous or ongoing) * Concomitant auto-immune disease * Other investigational product ongoing * Ongoing immunosuppressive treatment * Ongoing treatment at risk for inducing torsades de pointes * QTcF \> 450ms despite correction of predisposing factors (i.e electrolytes…) * Congenital long QTcF * Unstabilised thyroid disorder * No health insurance coverage

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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

  • Franck NICOLINI

    Lyon, 04 78 86 22 50, France

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