Acute Myeloid LeukemiaMOLAMNCT04931992
Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.
An observational study of Acute Myeloid Leukemia, run by University Hospital, Angers at 1 site in France.
Trial summary
Despite good initial response, some patients with core binding factor and/or NPM1-mutated AML eventually relapse. Some of these patients can be identified earlier on, before overt cytological relapse, when followed for minimal residual disease. Read more about this study
- Who is it for?
- Ages 18 to 61 years
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 31 Dec 2021
- 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 to 61 years
- All sexes
- Adult
Study population: Adult patients < 61 years with CBF and/or NPM1-mutated AML in CR1 after induction therapy who did not receive allogeneic stem transplantation and who were followed for measurable residual disease after completion of treatment.
Who may be able to join
- Patients between 18 and 61 years
- Diagnosis between 2010 and 2019
- Core binding factor and/or NPM1 acute myeloid leukemia
- First complete remission after induction therapy
- Measurable residual disease measurement after end of consolidation therapy
Who cannot join
- Acute promyelocytic leukemia
- Allogeneic stem cell transplantation in CR1
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Angers University Hospital
Angers
Corentin Orvain, MD, PhD, +33241354475, corentin.orvain@chu-angers.fr
About this study
Despite good initial response, some patients with core binding factor and/or NPM1-mutated AML eventually relapse. Some of these patients can be identified earlier on, before overt cytological relapse, when followed for minimal residual disease. The outcome of patients treated when molecular relapse is confirmed, before overt cytological relapse, is not well known. This multi-center retrospective will therefore study the outcome of these patients and try to specify the role of allogeneic stem cell transplantation in this setting.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- No intervention
- 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.
No interventionOther
Retrospective analysis
| Study group | Role | What they receive |
|---|---|---|
| Molecular relapse | Confirmed molecular relapse, without overt cytological relapse Receives: Other: No intervention | |
| Cytological relapse | Overt cytological relapse, without prior molecular relapse Receives: Other: No intervention | |
| Persistent responders | No molecular or cytological relapse during follow-up Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Measured: Up to 5 years
Secondary outcomes (1)
Overall survival
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931992
- Sponsor's protocol ID
- 202100042
- Acronym
- MOLAM
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.
- ClinicalTrials.gov ID
- NCT04931992
- Acronym / sponsor ID
- MOLAM / 202100042
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Jun 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.
Despite good initial response, some patients with core binding factor and/or NPM1-mutated AML eventually relapse. Some of these patients can be identified earlier on, before overt cytological relapse, when followed for minimal residual disease. The outcome of patients treated when molecular relapse is confirmed, before overt cytological relapse, is not well known. This multi-center retrospective will therefore study the outcome of these patients and try to specify the role of allogeneic stem cell transplantation in this setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Molecular relapse | – | Other: No interventionConfirmed molecular relapse, without overt cytological relapse |
| Cytological relapse | – | Other: No interventionOvert cytological relapse, without prior molecular relapse |
| Persistent responders | – | Other: No interventionNo molecular or cytological relapse during follow-up |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Age groups
- Adult
- Study population
- Adult patients < 61 years with CBF and/or NPM1-mutated AML in CR1 after induction therapy who did not receive allogeneic stem transplantation and who were followed for measurable residual disease after completion of treatment.
Key inclusion criteria (5 listed)
- Patients between 18 and 61 years
- Diagnosis between 2010 and 2019
- Core binding factor and/or NPM1 acute myeloid leukemia
- First complete remission after induction therapy
- Measurable residual disease measurement after end of consolidation therapy
Key exclusion criteria (2 listed)
- Acute promyelocytic leukemia
- Allogeneic stem cell transplantation in CR1
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 |
|---|---|---|
| No interventionRetrospective analysis | Other | Cytological relapse, Molecular relapse, Persistent responders |
Primary outcome
Event-free survival
Time frame: Up to 5 years
1 secondary outcome
Overall survival
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by University Hospital, Angers at 1 site in France.
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 Jun 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 France. 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?
Contact Corentin Orvain, MD, PhD (+33241354475, corentin.orvain@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: Up to 5 years). 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 Jun 2021.