A patient guided dose reduction strategy of tyrosine kinase inhibitors in chronic myeloid leukaemia

A patient guided dose reduction strategy of tyrosine kinase inhibitors in chronic myeloid leukaemia: a prospective, multi-centre, non-randomised non-inferiority study. - RODEO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006581-20-NL

Enrollment

106

Registered

2022-02-21

Start date

2022-05-11

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic myeloid leukaemia MedDRA version: 20.0 Level: HLT Classification code 10024296 Term: Leukaemias chronic myeloid System Organ Class: 100000004851

Interventions

Trade Name: Imatinib Pharmaceutical Form: Tablet INN or Proposed INN: Imatinib CAS Number: 152459-95-5 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 100-400 Trad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All adult CML patients (aged = 18 years) in chronic phase, who are treated with a TKI (imatinib, bosutinib, dasatinib, nilotinib, ponatinib), who have reached optimal treatment response i.e. at least major molecular response (MMR or MR3) are eligible for participation. MMR is defined as two consecutive BCR-ABL levels =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Patients with molecular or cytogenetic failure to previous TKI or who have undergone previous allogeneic hematopoietic stem cell transplantation will be excluded. Furthermore, patients who are in accelerated phase or blast crisis or using a TKI directed by known kinase-domain mutations will be excluded as well. Other exclusion criteria are pregnancy, lactation or a life expectancy of less than a year.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to investigate whether the proportion of patients with loss of MMR does not exceed the non-inferiority margin of 19% at 12 months after dose reduction. ;Secondary Objective: Secondary objectives are related to 1)dose reduction, 2) shared decision making and 3)feasibility of the strategy in clinical practice. -Objectives related to dose reduction: To assess the impact of dose reduction on the number and severity of (patient-reported) side effects, patients’ quality of life, patients’ beliefs about medicines, costs -Objectives related to shared decision making: To evaluate the shared decision-making process, to assess the impact of the decision making on patients’ distress and remorse -Objectives related to the feasibility of the strategy in clinical daily practice: To assess actual use and experiences of the patient-guided dose reduction strategy in clinical practice among patients and healthcare providers, using a process evaluation ;Primary end point(s): The primary study outcome is the proportion of patients with loss of MMR at 12 months after dose reduction. ;Timepoint(s) of evaluation of this end point: The most recent BCR-ABL1 level (no older than 6 weeks) will be used as baseline BCR-ABL1 measurement. 6 weeks after dose reduction 1 and 2, an extra blood sample is drawn. Thereafter, monitoring will be performed 12-weekly following monitoring recommendations by the European LeukemiaNet	—

Measure

Time frame

Main Objective: The primary objective of this study is to investigate whether the proportion of patients with loss of MMR does not exceed the non-inferiority margin of 19% at 12 months after dose reduction. ;Secondary Objective: Secondary objectives are related to 1)dose reduction, 2) shared decision making and 3)feasibility of the strategy in clinical practice. -Objectives related to dose reduction: To assess the impact of dose reduction on the number and severity of (patient-reported) side effects, patients’ quality of life, patients’ beliefs about medicines, costs -Objectives related to shared decision making: To evaluate the shared decision-making process, to assess the impact of the decision making on patients’ distress and remorse -Objectives related to the feasibility of the strategy in clinical daily practice: To assess actual use and experiences of the patient-guided dose reduction strategy in clinical practice among patients and healthcare providers, using a process evaluation ;Primary end point(s): The primary study outcome is the proportion of patients with loss of MMR at 12 months after dose reduction. ;Timepoint(s) of evaluation of this end point: The most recent BCR-ABL1 level (no older than 6 weeks) will be used as baseline BCR-ABL1 measurement. 6 weeks after dose reduction 1 and 2, an extra blood sample is drawn. Thereafter, monitoring will be performed 12-weekly following monitoring recommendations by the European LeukemiaNet

—

Secondary

Measure	Time frame
Secondary end point(s): Changes before and after dose reduction regarding - number and severity of (patient reported) side effects: (patient-reported) Side effects will be assessed at baseline, at 6 weeks after dose reduction and then 12-weekly during follow-up. - Patients' quality of life: Quality of Life will be assessed at baseline, month 6 and month 12 of follow-up. - Patients' belief about medicine: The BMQ-specific will be assessed at baseline, month 6 and month 12 of follow-up. - Costs including medication costs, healthcare costs and societal costs: Medication costs are collected per patient by discharge information obtained from the pharmacy at 12 months after follow-up. Healthcare costs (e.g. DBC costs and add-on costs) will be obtained from the electronic patient files. Healthcare resource use and productivity will be collected using the Medical Consumption questionnaire (iMCQ) and the Productivity Cost Questionnaire (iPCQ). The iMCQ includes questions about whether patients have visited or consulted healthcare providers. Healthcare consumption will be calculated by multiplying measured volumes of care by the cost price per unit of care [18]. The iPCQ maps the costs of reduced productivity in paid and unpaid work [19]. Both questionnaires will be assessed at baseline, and at 6- and 12-months follow-up. End points related to the shared decision making process - level of distress and remorse: The effect of the decision to lower TKI dose on the level of distress will be evaluated among patients at 6 weeks follow-up using the Decisional conflict scale, a 16-item questionnaire for assessment of uncertainty in choosing options, factors contributing to uncertainty, and effective decision making. At 12-months follow up we will measure regret or remorse using the Decisional regret scale - patient involvement during shared decision making using Observer OPTION during the first consult, and SDM-Q9/SDM-DOC during the second consult Endpoints related to f	—

Measure

Time frame

Secondary end point(s): Changes before and after dose reduction regarding - number and severity of (patient reported) side effects: (patient-reported) Side effects will be assessed at baseline, at 6 weeks after dose reduction and then 12-weekly during follow-up. - Patients' quality of life: Quality of Life will be assessed at baseline, month 6 and month 12 of follow-up. - Patients' belief about medicine: The BMQ-specific will be assessed at baseline, month 6 and month 12 of follow-up. - Costs including medication costs, healthcare costs and societal costs: Medication costs are collected per patient by discharge information obtained from the pharmacy at 12 months after follow-up. Healthcare costs (e.g. DBC costs and add-on costs) will be obtained from the electronic patient files. Healthcare resource use and productivity will be collected using the Medical Consumption questionnaire (iMCQ) and the Productivity Cost Questionnaire (iPCQ). The iMCQ includes questions about whether patients have visited or consulted healthcare providers. Healthcare consumption will be calculated by multiplying measured volumes of care by the cost price per unit of care [18]. The iPCQ maps the costs of reduced productivity in paid and unpaid work [19]. Both questionnaires will be assessed at baseline, and at 6- and 12-months follow-up. End points related to the shared decision making process - level of distress and remorse: The effect of the decision to lower TKI dose on the level of distress will be evaluated among patients at 6 weeks follow-up using the Decisional conflict scale, a 16-item questionnaire for assessment of uncertainty in choosing options, factors contributing to uncertainty, and effective decision making. At 12-months follow up we will measure regret or remorse using the Decisional regret scale - patient involvement during shared decision making using Observer OPTION during the first consult, and SDM-Q9/SDM-DOC during the second consult Endpoints related to f

—

Countries

Netherlands

Contacts

Public ContactTrialbureau Hematologie

Radboud university medical centre

studies.hemat@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026