Myeloid Mutations Register in R/R CML

October 4, 2021 updated by: Grupo Cooperativo de Hemopatías Malignas

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Estado De México
      • Huixquilucan, Estado De México, Mexico, 52763
        • Recruiting
        • Grupo Cooperativo de Hemopatías Malignas
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of myeloid mutations by Next Generation Sequence
Time Frame: 1 year
Detection of positive myeloid mutations at detection of relapse or refractoriness to ITK treatment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Cooperativo de Hemopatías Malignas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

March 30, 2022

Study Registration Dates

First Submitted

September 6, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAL368

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Myeloid Leukaemia Recurrent

Clinical Trials on Myeloid mutations measurement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe