Patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukaemia (RODEO): a prospective, multicentre, single-arm study

Phase 4

Recruiting

• Conditions: chronic leukemia; chronic myeloid leukemia; CML; 10018849

• Registration Number: NL-OMON52067
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

- Aged >= 18 years
- Diagnosed with chronic phase CML
- treated with a TKI (imatinib, bosutinib, dasatinib, nilotinib, ponatinib,
there are no restrictions regarding using a lower than standard dose at
inclusion, or previously having switched from TKI due to toxicity
- major molecular response (MMR) or better for an uninterrupted period of at
least 6 months at inclusion date
- Able and willing to participate
- Has provided written informed consent

Exclusion Criteria

- Inability to understand the nature and extent of the trial and the procedures
required (left at the discretion of the treating physician)
- Previous loss of MMR on a reduced TKI dose due to intolerability
- Molecular or cytogenetic failure to previous TKI
- Previous allogeneic hematopoietic stem cell transplantation
- CML in accelerated phase or blast crisis
- Pregnancy or lactation
- Life expectancy <= 1 year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to assess the proportion of patients<br /><br>with treatment failure at 12 months after first dose reduction, defined as<br /><br>patients who have restarted their initial dose due to (expected) loss of MMR. </p><br>