Acute Myeloid LeukemiaNCT04242849
IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up
An observational study of Acute Myeloid Leukemia, run by Josep Carreras Leukaemia Research Institute.
Trial summary
In a spanish series of AML patients it is intended to perform, at the moment of diagnosis, pyrosequencing of IDH1 and IDH2 genes. Taking into account the incidence of AML in the area, it is planed to study 100 patients per year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 354 participants
- Where
- No sites listed yet
- Study dates
- 23 May 2016to 16 Jan 2020
- Phase
- Observational
- 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
Study population: Patients >18 years old with de novo acute myeloid leukemia (AML).
Who may be able to join
- Patients >18 years old with de novo acute myeloid leukemia will be included. All patients will be treated according to clinical routine.
Who cannot join
- Patients not following the above criteria.
About this study
In a spanish series of AML patients it is intended to perform, at the moment of diagnosis, pyrosequencing of IDH1 and IDH2 genes. Taking into account the incidence of AML in the area, it is planed to study 100 patients per year.
Among the cases with IDH1/2 mutations, targeted deep sequencing (TDS) of a panel covering coding regions of 40 myeloid related genes will be applied. With TDS, pyrosequencing results will be validated at the same time that prognosis value of co-mutated genes could be studied. Furthermore, with TDS, molecular architecture of IDH1 and IDH2 mutated cases might be better understood.
- Conditions
- Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IDH1/2 mutated patients | Patients harboring mutations in IDH1 or IDH2 genes | |
| Patients without IDH1/2 mutations | Patients that don´t present any mutation in IDH1/2 genes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of IDH1/2 mutation
Detection of mutations in IDH1 and IDH2 genes
Measured: 1 day
Secondary outcomes (1)
Detection of co-mutations
Screening of aditional mutations in those cases with IDH1/2 mutation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start23 May 2016
- Primary completion27 Dec 2019
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josep Carreras Leukaemia Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242849
- Sponsor's protocol ID
- N/A-NI-AML-PI-007344
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 21 Feb 2025
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up
- ClinicalTrials.gov ID
- NCT04242849
- Acronym / sponsor ID
- N/A-NI-AML-PI-007344
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Josep Carreras Leukaemia Research InstituteUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 23 May 2016 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 27 Jan 2020 (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.
In a spanish series of AML patients it is intended to perform, at the moment of diagnosis, pyrosequencing of IDH1 and IDH2 genes. Taking into account the incidence of AML in the area, it is planed to study 100 patients per year.
Among the cases with IDH1/2 mutations, targeted deep sequencing (TDS) of a panel covering coding regions of 40 myeloid related genes will be applied. With TDS, pyrosequencing results will be validated at the same time that prognosis value of co-mutated genes could be studied. Furthermore, with TDS, molecular architecture of IDH1 and IDH2 mutated cases might be better understood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDH1/2 mutated patients | – | –Patients harboring mutations in IDH1 or IDH2 genes |
| Patients without IDH1/2 mutations | – | –Patients that don´t present any mutation in IDH1/2 genes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >18 years old with de novo acute myeloid leukemia (AML).
Key inclusion criteria (1 listed)
- Patients >18 years old with de novo acute myeloid leukemia will be included. All patients will be treated according to clinical routine.
Key exclusion criteria (1 listed)
- Patients not following the above criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of IDH1/2 mutation
Time frame: 1 day
Detection of mutations in IDH1 and IDH2 genes
1 secondary outcome
Detection of co-mutations
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Josep Carreras Leukaemia Research Institute.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of IDH1/2 mutation (time frame: 1 day). 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 21 Feb 2025.