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Myeloid Mutations Register in R/R CML

NCT ID: NCT05080829

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Myeloid Leukaemia Recurrent Chronic Myeloid Leukemia, in Relapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Mutation Register

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

Group Type EXPERIMENTAL

Myeloid mutations measurement

Intervention Type DIAGNOSTIC_TEST

Measure of myeloid mutations by NGS when detection of refractory or relapsed CML is done

Interventions

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Myeloid mutations measurement

Measure of myeloid mutations by NGS when detection of refractory or relapsed CML is done

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Cooperativo de Hemopatías Malignas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Grupo Cooperativo de Hemopatías Malignas

Huixquilucan, State of Mexico, Mexico

Site Status RECRUITING

Countries

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Mexico

Facility Contacts

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Roberto Ovilla-Martinez, MD

Role: primary

[email protected]
(55)5246-5000 ext. 4830

Pamela E Baez Islas, MD

Role: backup

[email protected]
(55)5246-5000 ext. 4830

Other Identifiers

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HAL368

Identifier Type: -

Identifier Source: org_study_id