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Completed

NCT Number: NCT01916785

OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy)

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.

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.

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Key information

Conditions

Chronic Myelogenous Leukemia, BCR/ABL Positive Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southern Alberta Cancer Research Institute, Calgary, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

dasatinib

Drug

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

Other names: Sprycel®

Primary outcomes

  1. Cumulative rate of significant AE

    Time frame: 12 months therapy

    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

Secondary outcomes

  1. Rate of treatment interruptions

    Time frame: 12 months therapy

    To compare the rate of treatment interruptions

  2. Cumulative duration of dasatinib interruption

    Time frame: 12 months therapy

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

  3. Mean dose of dasatinib

    Time frame: 12 months therapy

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

  4. Cumulative rate of complete cytogenetic response

    Time frame: 12 months therapy

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

  5. Cumulative rate of major molecular response

    Time frame: 12 months therapy

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

  6. Median dose of dasatinib administered

    Time frame: 12 months therapy

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

  7. Cumulative rate of complete molecular response

    Time frame: 12 months therapy

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

  8. Time to molecular response

    Time frame: 12 months therapy

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

  9. Relationship between peak plasmatic level and efficacy

    Time frame: 12 months therapy

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

  10. Relationship between through plasmatic level and efficacy

    Time frame: 12 months therapy

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

  11. Progression-free survival at 5 years

    Time frame: 12 months therapy

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

  12. Overall survival at 5 years

    Time frame: 12 months therapy

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

  13. Lymphocyte populations before and during dasatinib therapy

    Time frame: 12 months therapy

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

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

    Time frame: 12 months therapy

    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)

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Collaborators

  • Maisonneuve-Rosemont Hospital
  • University Hospital, Bordeaux

Registry information

Official study 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).

Acronym: OPTIM-DASA

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 6, 2013
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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