2024-516511-24-00CompletedPhase 4
A Patient guided dose reduction strategy of tyrosine kinase inhibitors in chronic myeloid leukaemia: RODEO study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 136 (actual)
- First submitted
- 3 Sept 2024
- Start date
- 14 Nov 2024
- Lead sponsor
- Stichting Radboud universitair medisch centrum
- Diseases
- Chronic myeloid leukaemia
- EU CT number
- 2024-516511-24-00
- EudraCT number
- 2021-006581-20
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 136
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Completed |
| Reinier de Graaf Groep | Delft | Netherlands | Completed |
| Albert Schweitzer Ziekenhuis | Dordrecht | Netherlands | Completed |
| Catharina Ziekenhuis Stichting | Eindhoven | Netherlands | Completed |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Completed |
| Zuyderland Medisch Centrum Stichting | Heerlen | Netherlands | Completed |
| Medisch Centrum Leeuwarden B.V. | Leeuwarden | Netherlands | Completed |
| Radboud universitair medisch centrum Stichting | Nijmegen | Netherlands | Completed |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.