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Status unknownNCT05080829Updated Oct 18, 2021

Myeloid Mutations Register in R/R CML

An interventional study of Myeloid mutations measurement in Chronic Myeloid Leukaemia Recurrent and Chronic Myeloid Leukemia, in Relapse, sponsored by Grupo Cooperativo de Hemopatías Malignas. Status unknown at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-18.

Sponsored by Grupo Cooperativo de Hemopatías Malignas · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2021, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Myeloid Leukaemia Recurrent
  • Chronic Myeloid Leukemia, in Relapse

Keywords

  • chronic myeloid leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 29 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Grupo Cooperativo de Hemopatías Malignas is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Lack of information to complete the register
  • Failure to response achievement due lack of adherence to treatment
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (estimated)

Study arms

  • Experimental
    Mutation Register

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

    Diagnostic Test: Myeloid mutations measurement

Interventions

  • Diagnostic testMyeloid mutations measurement

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

06

What researchers measure

Primary outcomes

  1. Presence of myeloid mutations by Next Generation Sequence

    Detection of positive myeloid mutations at detection of relapse or refractoriness to ITK treatment

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Grupo Cooperativo de Hemopatías Malignas
    Huixquilucan, Estado De México 52763, Mexico
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05080829
Lead sponsor
Grupo Cooperativo de Hemopatías Malignas
Responsible party
Sponsor
First posted
Oct 18, 2021
Start date
Mar 1, 2021
Primary completion
Feb 28, 2022 (estimated)
Completion
Mar 30, 2022 (estimated)
Last update
Oct 18, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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