NCT05080829

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

September 6, 2021

Last Update Submit

October 4, 2021

Conditions

Chronic Myeloid Leukaemia RecurrentChronic Myeloid Leukemia, in Relapse

Keywords

chronic myeloid leukemia

Outcome Measures

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

    1 year

Study Arms (1)

Mutation Register

EXPERIMENTAL

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

Diagnostic Test: Myeloid mutations measurement

Interventions

Myeloid mutations measurementDIAGNOSTIC_TEST

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

Mutation Register

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grupo Cooperativo de Hemopatías Malignas

Huixquilucan, State of Mexico, 52763, Mexico

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2021

First Posted

October 18, 2021

Study Start

March 1, 2021

Primary Completion

February 28, 2022

Study Completion

March 30, 2022

Last Updated

October 18, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)