NCT05130138

Brief Summary

The aim of this trial is therefore to identify concomitant treatments with taking Tyrosine Kinase Inhibitor (=TKI) in the indication of Chronic Myeloid Leukemia (CML), whatever the stage of the disease, via pharmaceutical conciliation. These concomitant treatments as well as their dosages will be correlated with the TKI dosage since patients must have a sufficient residual concentration to be considered effective and to confirm adherence to treatment, the leading cause of treatment failure. In the event of unsatisfactory results, pharmaceutical interventions may take place: changes in treatments (TKI and not TKI) and / or dosages. In case of modification, a new dosage of TKI should be carried out.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jan 2022Nov 2026

First Submitted

Initial submission to the registry

October 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 27, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

3.8 years

First QC Date

October 13, 2021

Last Update Submit

April 7, 2025

Conditions

Chronic Myeloid Leukemia

Keywords

hematologyChronic Myeloid LeukemiaTyrosine Kinase Inhibitorpharmaceutical conciliationpharmaceutical interventiondrug interactionsphytotherapytargeted therapies

Outcome Measures

Primary Outcomes (1)

  • Number of patients for whom pharmaceutical interventions have been done

    Number of patients for whom pharmaceutical interventions have been done secondly to pharmaceutical conciliation will be reported.

    12 months

Secondary Outcomes (6)

  • Molecular response

    12 months

  • Concomitant treatments

    12 months

  • Tyrosine kinase inhibitor observance

    12 months

  • Side effects

    12 months

  • Patients' satisfaction

    12 months

  • +1 more secondary outcomes

Study Arms (1)

Pharmaceutical conciliation

EXPERIMENTAL

Patients with Chronic Myeloid Leukemia taking TKI with a molecular response \< 4,5 Log will participate to pharmaceutical conciliation.

Other: Pharmaceutical intervention

Interventions

Pharmaceutical interventionOTHER

Patients with pharmacokinetic and/or pharmacodynamics interactions will be proposed to participate to educational sessions to discuss about treatments taken and modifications possibilities.

Pharmaceutical conciliation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major patient;
  • Patient affiliated to a social security scheme;
  • Patient suffering from Chronic Myeloid Leukemia, taking a Tyrosine Kinase Inhibitor (Imatinib, Nilotinib, Dasatinib, or Bosutinib);
  • Molecular response \< 4,5 Log;

You may not qualify if:

  • Legal incapacity or limited capacity ; Medical or psychological incapacity or limited capacity;
  • Not able to read and/or to write French;
  • Patient taking Ponatinib.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xavier SIMOENS, MD, PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth DAGUENET, doctor of science

CONTACT

0477822875elisabeth.daguenet@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2021

First Posted

November 22, 2021

Study Start

January 27, 2022

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)