Myeloid Mutations Register in R/R CML

Grupo Cooperativo de Hemopatías Malignas

Status: Unknown

Conditions: Chronic Myeloid Leukemia, in Relapse; Chronic Myeloid Leukaemia Recurrent

Treatments: Diagnostic Test: Myeloid mutations measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT05080829

HAL368

Details and patient eligibility

About

The aim of the study is to know the percentage of ABL mutations in patients with chronic myeloid leukemia that relapsed or are refractory to tyrosine-kinase inhibitors measured with a myeloid mutations panel by NGS.

Enrollment: 29 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CML diagnosis by the WHO 2016 criteria
• Failure to reach cytogenetic response of Ph chromosome of 36 to 95% at 3 months or BCR/ABL <10% at 6 months of treatment with TKI
• Progression or relapse of the disease after previous response to treatment with TKI
• Validation of adherence to treatment
• Inform consent

Exclusion criteria

• Lack of information to complete the register
• Failure to response achievement due lack of adherence to treatment

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Mutation Register

Experimental group

Description:

Measure of myeloid mutations after detection of relapse or refractoriness to ITK treatment

Treatment:

Diagnostic Test: Myeloid mutations measurement