Chronic Myeloid Leukaemia RecurrentNCT05080829
Myeloid Mutations Register in R/R CML
A study testing Myeloid mutations measurement in people with Chronic Myeloid Leukaemia Recurrent and Chronic Myeloid Leukemia, in Relapse, run by Grupo Cooperativo de Hemopatías Malignas at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukaemia Recurrent, Chronic Myeloid Leukemia, in Relapse
- What is being tested?
- Myeloid mutations measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lack of information to complete the register
- Failure to response achievement due lack of adherence to treatment
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Grupo Cooperativo de Hemopatías Malignas
Huixquilucan, State of Mexico, 52763
Roberto Ovilla-Martinez, MD, (55)5246-5000 ext. 4830, ovillarob@gmail.com
Pamela E Baez Islas, MD, (55)5246-5000 ext. 4830, drabaez.hematologia@gmail.com
About this study
Official title: 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.
- Being tested
- Myeloid mutations measurement
- Keywords
- chronic myeloid leukemia
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myeloid mutations measurementDiagnostic test
Measure of myeloid mutations by NGS when detection of refractory or relapsed CML is done
| Study group | Role | What they receive |
|---|---|---|
| Mutation Register | Experimental | Measure of myeloid mutations after detection of relapse or refractoriness to ITK treatment Receives: Diagnostic Test: Myeloid mutations measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of myeloid mutations by Next Generation Sequence
Detection of positive myeloid mutations at detection of relapse or refractoriness to ITK treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Mar 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukaemia RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Cooperativo de Hemopatías Malignas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080829
- Sponsor's protocol ID
- HAL368
- Status last verified
- Oct 2021
- First submitted
- 6 Sep 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABL Mutation Register in Patients With ITK Relapsed or Refractory Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05080829
- Acronym / sponsor ID
- HAL368
- Keywords
- chronic myeloid leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Grupo Cooperativo de Hemopatías MalignasUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mutation Register | Experimental | Diagnostic Test: Myeloid mutations measurementMeasure of myeloid mutations after detection of relapse or refractoriness to ITK treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Lack of information to complete the register
- Failure to response achievement due lack of adherence to treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myeloid mutations measurementMeasure of myeloid mutations by NGS when detection of refractory or relapsed CML is done | Diagnostic test | Mutation Register |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grupo Cooperativo de Hemopatías Malignas
Huixquilucan, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myeloid mutations measurement in people with Chronic Myeloid Leukaemia Recurrent and Chronic Myeloid Leukemia, in Relapse, run by Grupo Cooperativo de Hemopatías Malignas at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of myeloid mutations by Next Generation Sequence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.