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Chronic Myelogenous Leukemia, BCR/ABL PositivePhase 2OPTIM-DASANCT01916785

OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy)

A Phase 2 study testing Dasatinib in people with Chronic Myelogenous Leukemia, BCR/ABL Positive, run by Versailles Hospital at 34 sites in 2 countries.

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

This protocol is a multicentric interventional phase II study from the French CML Intergroup (FILMC). The core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dasatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
289 participants
Where
34 sitesin 2 countries
Study dates
May 2009to Dec 2013
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
  • ECOG Performance Status score 0-2
  • Philadelphia chromosome positive newly diagnosed (≤ 3 months) CP-CML
  • patients not previously treated except with hydroxyurea or imatinib (less than 4 weeks for imatinib)
  • Signed written inform consent
  • 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).
  • Adequate renal function defined as serum creatinine ≤ 3 times the institutional ULN.
  • 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 a tyrosine kinase inhibitor (TKI) except with imatinib during less than 4 weeks.
  • Pregnancy
  • Active malignancy
  • Uncontrolled or significant cardiovascular disease
  • Patients with QTc > 450 ms
  • Significant bleeding disorder unrelated to CML
  • Concurrent severe diseases which exclude the administration of therapy

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

France24 sites

  • CHU Angers

    Angers

  • Hôpital Avicenne

    Bobigny

  • Institut Bergonie

    Bordeaux

  • Hopital MORVAN

    Brest

  • CH René Dubos

    Cergy-Pontoise

  • Hôpital d'Instruction de Armées Percy

    Clamart

  • Hopital Henri MONDOR

    Créteil

  • Hôpital Claude Huriez

    Lille

  • CH Lyon Sud

    Lyon

  • Institut Paoli-Calmettes

    Marseille

  • Hôpital d'Annecy

    Metz-Tessy

  • C.H.U. Brabois

    Nancy

  • CHU Hoptel dieu

    Nantes

  • Hôpital l'Archet 1

    Nice

  • CHU Caremeau

    Nîmes

  • Hopital Saint Louis

    Paris

  • Hôpital Necker-Enfants Malades

    Paris

  • Hôpital St Antoine

    Paris

  • CHU Poitiers

    Poitiers

  • CHU Rennes - Pontchaillou

    Rennes

  • Centre René Huguenin

    Saint-Cloud

  • Hôpital Purpan

    Toulouse

  • CHRU Bretonneau

    Tours

  • Central Hospital

    Versailles

Other trials in France

Canada10 sites

  • Southern Alberta Cancer Research Institute

    Calgary

  • Hôpital Charles LeMoyne

    Greenfield Park

  • Queen elisabeth II Health Sciences Center

    Halifax

  • CH Pierre LeGardeur

    Lachenaie

  • Moncton City Hospital

    Moncton

  • Hôpital Général Juif - Sir. Mortimer B. Davis

    Montreal

  • Hôpital Maisonneuve-Rosemont

    Montreal

  • Hôpital Royal Victoria

    Montreal

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

    Québec

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

    Québec

Other trials in Canada

About this study

Official title: A PROSPECTIVE RANDOMIZED PHASE II STUDY EVALUATING THE OPTIMIZATION OF THE RESIDUAL PLASMATIC LEVEL OF DASATINIB (SPRYCEL®) IN PATIENTS NEWLY DIAGNOSED WITH CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML).

This protocol is a multicentric interventional phase II study from the French CML Intergroup (FILMC).

The core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib.

Read more

The objective of this strategy is to improve the overall results of the treatment of early CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations.

The study will be conducted in selected FILMC and Canadian centers.

The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb. The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing authorization is granted in that indication.

Being tested
Dasatinib
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.

  • DasatinibDrug

    Also called Sprycel®

    Dasatinib is a multitargeted tyrosine kinase inhibitor with a 300-fold more potent activity on the BCR-ABL tyrosine kinase in vitro compared to imatinib mesylate

Study groups in NCT01916785
Study groupRoleWhat they receive
A1ExperimentalArm A1: Dasatinib dose adjustment based on Cmin ≥3nM value analysed on blood after 7-10 days dasatinib 100mg intake
Receives: Drug: Dasatinib
A2Active comparatorArm A2: Dasatinib standard dose (100mg/d) with Cmin ≥ 3nM analysed on blood after 7-10 days dasatinib 100mg intake
Receives: Drug: Dasatinib
BActive comparatorArm B : Dasatinib standard dose with Cmin < 3nM analysed on blood after 7-10 days dasatinib 100mg intake
Receives: Drug: Dasatinib

What is being measured

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

  1. Cumulative rate of significant AE

    The cumulative rate of serious AEs defined by grade 3-4 fluid retention, all grade pleural effusion, haematological grade 3-4 AEs related to dasatinib and/or all AE leading to dasatinib discontinuation within the first year of therapy

    Measured: 12 months therapy

Secondary outcomes (14)

  1. Rate of treatment interruptions

    To compare the rate of treatment interruptions

    Measured: 12 months therapy

  2. Cumulative duration of dasatinib interruption

    To compare the cumulative duration of dasatinib interruption C. To compare the median dose of dasatinib administered during the first 12 months

    Measured: 12 months therapy

  3. Mean dose of dasatinib

    To compare the mean dose of dasatinib administered during the first 12 months

    Measured: 12 months therapy

  4. Cumulative rate of complete cytogenetic response

    To compare the cumulative rate of complete cytogenetic response (CCR) at 6, 12 and 18 months, and every 12 months thereafter

    Measured: 12 months therapy

  5. Cumulative rate of major molecular response

    To compare the cumulative rate of major molecular response (MMR) at 3, 6, 12, and 18 months, and every 6 months thereafter

    Measured: 12 months therapy

  6. Median dose of dasatinib administered

    To compare the median dose of dasatinib administered during the first 12 months

    Measured: 12 months therapy

  7. Cumulative rate of complete molecular response

    To compare the cumulative rate of complete molecular response at 3, 6, 12 and 18 months, and every 6 months thereafter

    Measured: 12 months therapy

  8. Time to molecular response

    To compare the time to molecular response (major or complete)

    Measured: 12 months therapy

  9. Relationship between peak plasmatic level and efficacy

    To analyse the relationship between peak plasmatic level (Cmax) and efficacy in the three arms

    Measured: 12 months therapy

  10. Relationship between through plasmatic level and efficacy

    To analyse the relationship between through plasmatic level (Cmin) and efficacy in the three arms

    Measured: 12 months therapy

  11. Progression-free survival at 5 years

    To compare the progression-free survival (PFS) at 5 years in the three arms

    Measured: 12 months therapy

  12. Overall survival at 5 years

    To compare the overall survival at 5 years in the three arms

    Measured: 12 months therapy

  13. Lymphocyte populations before and during dasatinib therapy

    To analyse lymphocyte populations before and during dasatinib therapy (for French participating centers - see appendix 14).

    Measured: 12 months therapy

  14. Rate of sustained major molecular remission after dasatinib discontinuation in patients in complete molecular response

    To evaluate the rate of sustained major molecular remission after dasatinib discontinuation in patients in complete molecular response, CMR (undetectable BCR-ABL transcript, BCR-ABL/ABL IS ratio < 1x10-5)

    Measured: 12 months therapy

Timeline

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

  1. First posted6 Aug 2013 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2013
  4. Study completionDec 2013

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
Parallel groups
Masking
None (open label)
Enrolment
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01916785
Sponsor's protocol ID
EudraCT 2008-006854-17
Acronym
OPTIM-DASA
Status last verified
Jul 2026
First submitted
18 Dec 2012
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Rousselot P, Mollica L, Guilhot J, Guerci A, Nicolini FE, Etienne G, Legros L, Charbonnier A, Coiteux V, Dartigeas C, Escoffre-Barbe M, Roy L, Cony-Makhoul P, Dubruille V, Gardembas M, Huguet F, Rea D, Cayssials E, Guilhot F, Bergeron A, Molimard M, Mahon FX, Cayuela JM, Busque L, Bouchet S. Dasatinib dose optimisation based on therapeutic drug monitoring reduces pleural effusion rates in chronic myeloid leukaemia patients. Br J Haematol. 2021 Jul;194(2):393-402. doi: 10.1111/bjh.17654. Epub 2021 Jun 30.

    PubMed 34195988

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib in people with Chronic Myelogenous Leukemia, BCR/ABL Positive, run by Versailles Hospital at 34 sites in 2 countries.

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 8 inclusion and 8 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 34 sites in France, Canada. 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?

Cumulative rate of significant AE (time frame: 12 months therapy). 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 NCT01916785, 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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