A Patient guided dose reduction strategy of tyrosine kinase inhibitors in chronic myeloid leukaemia: RODEO study
Key facts
- Where
- Amsterdam, Delft, Dordrecht, Eindhoven, Groningen, Heerlen, Leeuwarden, Nijmegen és Utrecht, HollandiaSee the 9 sites
- Phase
- 4. fázis
Where in Hollandia
- Amsterdam UMC StichtingAmsterdam, HollandiaNo longer taking part
- Reinier de Graaf GroepDelft, HollandiaNo longer taking part
- Albert Schweitzer ZiekenhuisDordrecht, HollandiaNo longer taking part
- Catharina Ziekenhuis StichtingEindhoven, HollandiaNo longer taking part
- Universitair Medisch Centrum GroningenGroningen, HollandiaNo longer taking part
- Zuyderland Medisch Centrum StichtingHeerlen, HollandiaNo longer taking part
- Medisch Centrum Leeuwarden B.V.Leeuwarden, HollandiaNo longer taking part
- Radboud universitair medisch centrum StichtingNijmegen, HollandiaNo longer taking part
- Universitair Medisch Centrum UtrechtUtrecht, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stichting Radboud universitair medisch centrum
- Trial code
- EU 2024-516511-24-00
- Record updated
- 2024. november 14.
- Original description
The primary objective of this study is to assess the proportion of patients with treatment failure at 12 months after first dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of MMR.Read full original descriptionShow less
The primary objective of this study is to assess the proportion of patients with treatment failure at 12 months after first dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of MMR.
Inclusion: 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: 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.