Cure My Disease

Don't miss your cure!

 Log in / Sign up

Personalized dasatinib dosing aims to tame leukemia with fewer side effects

NCT ID NCT01916785

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether adjusting the daily dose of the leukemia drug dasatinib based on a patient's blood levels can improve safety and effectiveness. Adults newly diagnosed with chronic phase chronic myeloid leukemia (CML) will receive either standard dosing or a dose tailored to their dasatinib blood levels. The goal is to reduce serious side effects while maintaining control of the cancer.

What this could mean

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

Active substance
Dasatinib (Sprycel)
What this could lead to
If successful, this approach could reduce side effects and improve treatment outcomes for people with chronic myeloid leukemia by personalizing their daily dose.
What could go wrong
This is a Phase 2 trial, so the strategy may not prove better than standard dosing. There is also a risk of side effects like fluid retention or low blood counts.

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

289 people

The number who actually took part.

Start date

May 2009

Finished

Dec 2013

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. ECOG Performance Status score 0-2 3. Philadelphia chromosome positive newly diagnosed (≤ 3 months) CP-CML 4. patients not previously treated except with hydroxyurea or imatinib (less than 4 weeks for imatinib) 5. Signed written inform consent 6. Adequate hepatic function defined as: total bilirubin ≤ 2.0 times the institutional ULN; ALT and AST ≤ 2.5 times the institutional upper limit of normal (ULN). 7. Adequate renal function defined as serum creatinine ≤ 3 times the institutional ULN. 8. 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 a tyrosine kinase inhibitor (TKI) except with imatinib during less than 4 weeks. 3. Pregnancy 4. Active malignancy 5. Uncontrolled or significant cardiovascular disease 6. Patients with QTc \> 450 ms 7. Significant bleeding disorder unrelated to CML 8. Concurrent severe diseases which exclude the administration of therapy

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic myelogenous leukemia, BCR/ABL positive are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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 myelogenous leukemia, BCR/ABL positive

Contacts and locations

Locations

  • C.H.U. Brabois

    Nancy, France

  • CH Lyon Sud

    Lyon, France

  • CH Pierre LeGardeur

    Lachenaie, Canada

  • CH René Dubos

    Cergy-Pontoise, France

  • CHRU Bretonneau

    Tours, France

  • CHU Angers

    Angers, France

  • CHU Caremeau

    Nîmes, France

  • CHU Hoptel dieu

    Nantes, France

  • CHU Poitiers

    Poitiers, France

  • CHU Rennes - Pontchaillou

    Rennes, France

  • Central Hospital

    Versailles, France

  • Centre René Huguenin

    Saint-Cloud, France

  • Hopital Henri MONDOR

    Créteil, France

  • Hopital MORVAN

    Brest, France

  • Hopital Saint Louis

    Paris, France

  • Hôpital Avicenne

    Bobigny, France

  • Hôpital Charles LeMoyne

    Greenfield Park, Canada

  • Hôpital Claude Huriez

    Lille, France

  • Hôpital Général Juif - Sir. Mortimer B. Davis

    Montreal, Canada

  • Hôpital Maisonneuve-Rosemont

    Montreal, Canada

  • Hôpital Necker-Enfants Malades

    Paris, France

  • Hôpital Purpan

    Toulouse, France

  • Hôpital Royal Victoria

    Montreal, Canada

  • Hôpital St Antoine

    Paris, France

  • Hôpital d'Annecy

    Metz-Tessy, France

  • Hôpital d'Instruction de Armées Percy

    Clamart, France

  • Hôpital de l'Enfant Jésus - Centre hospitalier affilié universitaire de Québec

    Québec, Canada

  • Hôpital l'Archet 1

    Nice, France

  • Institut Bergonie

    Bordeaux, France

  • Institut Paoli-Calmettes

    Marseille, France

  • Moncton City Hospital

    Moncton, Canada

  • Pavillon Hôtel-Dieu de Québec - Centre hospitalier universitaire de Québec

    Québec, Canada

  • Queen elisabeth II Health Sciences Center

    Halifax, Canada

  • Southern Alberta Cancer Research Institute

    Calgary, Canada