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Leukemia, Myelogenous, Chronic, BCR-ABL PositivePhase 2OPTIMIMATINIBNCT02896842

A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate Plasmatic Through Level in Patients Newly Diagnosed With CP-CML

A Phase 2 study testing Posology dose modification and active comparator in people with Leukemia, Myelogenous, Chronic, BCR-ABL Positive, run by Versailles Hospital at 19 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Posology dose modification and active comparator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
19 sitesFrance
Study dates
Sep 2010to Dec 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patient ≥ 18 years
  • Philadelphia chromosome positive newly diagnosed chronic myelogenous leukaemia (≤ 4 months) in first chronic phase.
  • Not previously treated with tyrosine kinase inhibitors other than imatinib
  • Prior treatment with imatinib during less than 13 weeks
  • Signed written inform consent
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception

Who cannot join

  • Patients with BCR-ABL positive, Philadelphia negative CML
  • Patient previously treated with TKI other than imatinib
  • Pregnancy
  • Active malignancy
  • Concurrent severe diseases which exclude the administration of therapy

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • CHU angers

    Angers

  • CH d'Annecy

    Annecy

  • CH argenteuil

    Argenteuil

  • CHU Bordeaux

    Bordeaux

  • Institut Bergonié

    Bordeaux

  • CH Boulogne

    Boulogne

  • CHU CAEN

    Caen

  • CH de Dieppe

    Dieppe

  • CH Dunkerque

    Dunkirk

  • CH Versailles

    Le Chesnay

  • CHU Lille

    Lille

  • CHU Lyon

    Lyon

  • CH Meaux

    Meaux

  • Hopital Bon secours

    Metz

  • CHU Nice

    Nice

  • Hopital La Source

    Orléans La Source

  • Hopital Necker

    Paris

  • CHU Rennes

    Rennes

  • Hopital Purpan

    Toulouse

Other trials in France

About this study

Official title: A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate (Glivec®) Plasmatic Through Level in Patients Newly Diagnosed With Chronic Phase Chronic Myelogenous Leukaemia (CP-CML).

Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. The optimal IM daily dose is not yet determined and randomized studies addressing this question are on-going. First results from the TOPS trial (EHA 2008 congress) suggest a more rapid kinetic of response for patients treated with imatinib high dose. Recent studies revealed that initial Imatinib plasmatic dosage is predictive for achieving complete cytogenetic responses (CCR) and that a dosage of 1000 ng/ml is associated with a higher proportion of major molecular responses (MMR) (Picard et al., Blood 2007, Larson et al. Blood 2007).

Results from the study of Larson et al. indicate that around 40% of the patients had a trough plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major molecular response rate at 12 months for the patients with the lower plasmatic through level is 25.4% compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.

Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort 1) versus observation only (cohort 2). The patients with adequate imatinib dosage (> 1000 ng/ml) will be followed up according the ELN recommendation (cohort 3). Imatinib trough plasmatic level will then be rechecked every month thereafter for patients in cohort 1 and cohort 2 and every three months in cohort 3. The first endpoint of the study will be the rate of major molecular response at 12 months in cohort 1. Our hypothesis is to improve the 12 months MMR rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to 40% of MMR at 12 months.

Being tested
Posology dose modification, active comparator
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Posology dose modificationDrug

    Also called Cohort 1 : dose adjustment based on trough plasmatic

  • active comparatorOther

    Also called Cohort 2 : Imatinib standard dose

Study groups in NCT02896842
Study groupRoleWhat they receive
Control ArmNo interventioncohort 3: Imatinib through dosage ≥ 1000 ng/ml
Active comparatorActive comparatorCohort 2 : Imatinib standard dose Imatinib through dosage < 1000 ng/ml
Receives: Other: active comparator
Experimental armExperimentalCohort 1 : dose adjustment based on trough plasmatic level value Imatinib through dosage < 1000 ng/ml
Receives: Drug: Posology dose modification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The major molecular response rate at 12 months in cohort 1.

    Measured: 12 months

Secondary outcomes (9)

  1. Complete cytogenetic response at 6 and 12 months

    Measured: 12 months

  2. Major molecular response rate at 12 months in cohort 2 and cohort 3.

    Measured: 12 months

  3. Major molecular response at 3, 6, and 9 months

    Measured: 9 months

  4. Complete molecular response 6 and 12 months

    Measured: 12 months

  5. Relationship between plasmatic dosage and efficacy

    Measured: 12 months

  6. Relationship between plasmatic dosage and tolerance

    Measured: 12 months

  7. Progression free survival

    Measured: 5 years

  8. Event free survival

    Measured: 5 years

  9. Overall survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2016 (estimated)
  2. Study startSep 2010
  3. Primary completionMar 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02896842
Sponsor's protocol ID
09/38_ Optim Imatinib
Acronym
OPTIMIMATINIB
Status last verified
Jul 2026
First submitted
7 Sep 2016
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Johnson-Ansah H, Maneglier B, Huguet F, Legros L, Escoffre-Barbe M, Gardembas M, Cony-Makhoul P, Coiteux V, Sutton L, Abarah W, Pouaty C, Pignon JM, Choufi B, Visanica S, Deau B, Morisset L, Cayssials E, Molimard M, Bouchet S, Mahon FX, Nicolini F, Aegerter P, Cayuela JM, Delord M, Bruzzoni-Giovanelli H, Rousselot P; Groupe Francais pour la LMC (Fi-LMC). Imatinib Optimized Therapy Improves Major Molecular Response Rates in Patients with Chronic Myeloid Leukemia. Pharmaceutics. 2022 Aug 12;14(8):1676. doi: 10.3390/pharmaceutics14081676.

    PubMed 36015302

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Posology dose modification and active comparator in people with Leukemia, Myelogenous, Chronic, BCR-ABL Positive, run by Versailles Hospital at 19 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The major molecular response rate at 12 months in cohort 1. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02896842, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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