Acute Myeloid LeukemiaFERTILAMNCT04679285
Minimal Residual Disease Evaluation on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia, run by University Hospital, Lille at 1 site in France.
Trial summary
Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 2 to 40 years, women only
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2021to 4 Sep 2022
- 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 2 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients aged 2 to 40 year-old, who present at least one molecular marker at acute myeloid leukemia diagnosis and who undergo ovarian cryopreservation for fertility preservation at the time of complete remission, before hematopoietic stem cell transplantation.
Who may be able to join
- Patient diagnosed with AML
- At least one molecular marker identified at AML diagnosis
- Patients who undergo ovarian tissue cryopreservation for fertility preservation in complete remission, before hematopoietic stem cell transplantation.
Who cannot join
- Other diagnostic
- No marker available at AML diagnosis
- No bone marrow/ovarian fragment available at the time of complete remission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Assess Minimal Residual Disease on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia
Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation.
This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, Fertility preservation, Ovarian cryopreservation, Minimal residual disease
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm, Residual
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients without detectable MRD in ovarian tissue
Measured: Up to 6 months
Secondary outcomes (1)
Percentage of patients with MRD detected in ovarian tissue and bone marrow.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start26 Apr 2021
- Primary completion4 Sep 2022
- Study completion4 Sep 2022
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, LilleThe 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
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Canceropôle Nord Ouest, Saint-Louis Hospital, Paris, France
- Responsible party
- Sponsor
- Investigators
- Laurène Fenwarth, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679285
- Sponsor's protocol ID
- 2020_12
- Other IDs
- 2020-A01513-36
- Acronym
- FERTILAM
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Minimal Residual Disease on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04679285
- Acronym / sponsor ID
- FERTILAM / 2020_12
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, Fertility preservation, Ovarian cryopreservation, Minimal residual disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Canceropôle Nord Ouest, Saint-Louis Hospital, Paris, France
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 4 Sep 2022 (actual)
- Study completion
- 4 Sep 2022 (actual)
- First posted
- 22 Dec 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.
Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation.
This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 2 to 40 year-old, who present at least one molecular marker at acute myeloid leukemia diagnosis and who undergo ovarian cryopreservation for fertility preservation at the time of complete remission, before hematopoietic stem cell transplantation.
Key inclusion criteria (3 listed)
- Patient diagnosed with AML
- At least one molecular marker identified at AML diagnosis
- Patients who undergo ovarian tissue cryopreservation for fertility preservation in complete remission, before hematopoietic stem cell transplantation.
Key exclusion criteria (3 listed)
- Other diagnostic
- No marker available at AML diagnosis
- No bone marrow/ovarian fragment available at the time of complete remission
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
Percentage of patients without detectable MRD in ovarian tissue
Time frame: Up to 6 months
1 secondary outcome
Percentage of patients with MRD detected in ovarian tissue and bone marrow.
Time frame: Up to 1 month
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 23 Dec 2025.
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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.
Laurène Fenwarth, MD principal investigator
University Hospital, Lille
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, Lille 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 3 inclusion and 3 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 23 Dec 2025. 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?
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?
Percentage of patients without detectable MRD in ovarian tissue (time frame: Up to 6 months). 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 23 Dec 2025.