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

Phase 1

• Conditions: Chronic myeloid leukaemia; MedDRA version: 20.0Level: HLTClassification code 10024296Term: Leukaemias chronic myeloidSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2021-006581-20-NL
• Lead Sponsor: Radboud univeristy medical centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-21
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 106

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 <0,1% for at least 6 months. There are no restrictions regarding using a lower than standard dose, or previously having switched from TKI.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified