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Personalizing leukemia drug doses could boost treatment success

NCT ID NCT02896842

Disease control Sponsor: Versailles Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial investigates whether adjusting the dose of imatinib (Gleevec) based on the drug's level in the blood can improve outcomes for people newly diagnosed with chronic phase chronic myeloid leukemia (CML). Participants whose imatinib blood level is low after 28 days are randomly assigned to either have their dose adjusted or continue the standard dose. The study aims to see if dose personalization leads to a higher rate of major molecular response at 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
imatinib mesylate (Gleevec/Glivec)
What this could lead to
If successful, this could show that personalizing imatinib doses based on blood levels leads to better disease control for people with chronic myeloid leukemia.
What could go wrong
This is a mid-stage trial with a modest size, so results may not be conclusive. Dose adjustments could also increase side effects without improving outcomes.

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

139 people

The number who actually took part.

Start date

Sep 2010

Finished

Dec 2016

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 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: 1. Male or female patient ≥ 18 years 2. Philadelphia chromosome positive newly diagnosed chronic myelogenous leukaemia (≤ 4 months) in first chronic phase. 3. Not previously treated with tyrosine kinase inhibitors other than imatinib 4. Prior treatment with imatinib during less than 13 weeks 5. Signed written inform consent 6. Women of childbearing potential (WOCBP) must be using an adequate method of contraception Exclusion Criteria: 1. Patients with BCR-ABL positive, Philadelphia negative CML 2. Patient previously treated with TKI other than imatinib 3. Pregnancy 4. Active malignancy 5. Concurrent severe diseases which exclude the administration of therapy

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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.

Leukemia, myelogenous, chronic, BCR-ABL positive

Contacts and locations

Locations

  • CH Boulogne

    Boulogne, France

  • CH Dunkerque

    Dunkirk, France

  • CH Meaux

    Meaux, France

  • CH Versailles

    Le Chesnay, France

  • CH argenteuil

    Argenteuil, France

  • CH d'Annecy

    Annecy, France

  • CH de Dieppe

    Dieppe, France

  • CHU Bordeaux

    Bordeaux, France

  • CHU CAEN

    Caen, France

  • CHU Lille

    Lille, France

  • CHU Lyon

    Lyon, France

  • CHU Nice

    Nice, France

  • CHU Rennes

    Rennes, France

  • CHU angers

    Angers, France

  • Hopital Bon secours

    Metz, France

  • Hopital La Source

    Orléans La Source, France

  • Hopital Necker

    Paris, France

  • Hopital Purpan

    Toulouse, France

  • Institut Bergonié

    Bordeaux, France

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