Myeloid Mutations Register in R/R CML

Sponsor

Grupo Cooperativo de Hemopatías Malignas (Other)

Overall Status

Recruiting

CT.gov ID

NCT05080829

Collaborator

(none)

Enrollment

Location

Arm

12.9

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukaemia Recurrent Chronic Myeloid Leukemia, in Relapse	Diagnostic Test: Myeloid mutations measurement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

ABL Mutation Register in Patients With ITK Relapsed or Refractory Chronic Myeloid Leukemia

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mutation Register Measure of myeloid mutations after detection of relapse or refractoriness to ITK treatment	Diagnostic Test: Myeloid mutations measurement Measure of myeloid mutations by NGS when detection of refractory or relapsed CML is done

Arm

Intervention/Treatment

Experimental: Mutation Register

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

Diagnostic Test: Myeloid mutations measurement

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

Outcome Measures

Primary Outcome Measures

Presence of myeloid mutations by Next Generation Sequence [1 year]
Detection of positive myeloid mutations at detection of relapse or refractoriness to ITK treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grupo Cooperativo de Hemopatías Malignas	Huixquilucan	Estado De México	Mexico	52763

Sponsors and Collaborators

Grupo Cooperativo de Hemopatías Malignas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Grupo Cooperativo de Hemopatías Malignas

ClinicalTrials.gov Identifier:

NCT05080829

Other Study ID Numbers:

HAL368

First Posted:

Oct 18, 2021

Last Update Posted:

Oct 18, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Grupo Cooperativo de Hemopatías Malignas

chronic myeloid leukemia

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Results

No Results Posted as of Oct 18, 2021