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Myeloid Mutations Register in R/R CML

Primary Purpose

Chronic Myeloid Leukaemia Recurrent, Chronic Myeloid Leukemia, in Relapse

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Myeloid mutations measurement
Sponsored by
Grupo Cooperativo de Hemopatías Malignas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Myeloid Leukaemia Recurrent focused on measuring chronic myeloid leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Grupo Cooperativo de Hemopatías MalignasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mutation Register

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 6, 2021
Last Updated
October 4, 2021
Sponsor
Grupo Cooperativo de Hemopatías Malignas
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1. Study Identification

Unique Protocol Identification Number
NCT05080829
Brief Title
Myeloid Mutations Register in R/R CML
Official Title
ABL Mutation Register in Patients With ITK Relapsed or Refractory Chronic Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo Cooperativo de Hemopatías Malignas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukaemia Recurrent, Chronic Myeloid Leukemia, in Relapse
Keywords
chronic myeloid leukemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mutation Register
Arm Type
Experimental
Arm Description
Measure of myeloid mutations after detection of relapse or refractoriness to ITK treatment
Intervention Type
Diagnostic Test
Intervention Name(s)
Myeloid mutations measurement
Intervention Description
Measure of myeloid mutations by NGS when detection of refractory or relapsed CML is done
Primary Outcome Measure Information:
Title
Presence of myeloid mutations by Next Generation Sequence
Description
Detection of positive myeloid mutations at detection of relapse or refractoriness to ITK treatment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Grupo Cooperativo de Hemopatías Malignas
City
Huixquilucan
State/Province
Estado De México
ZIP/Postal Code
52763
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Ovilla-Martinez, MD
Phone
(55)5246-5000
Ext
4830
Email
ovillarob@gmail.com
First Name & Middle Initial & Last Name & Degree
Pamela E Baez Islas, MD
Phone
(55)5246-5000
Ext
4830
Email
drabaez.hematologia@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Myeloid Mutations Register in R/R CML

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