Acute Myeloid LeukemiaORAZ-351NCT06349239
Oral Azacitidine Maintenance Post-CPX 351
An observational study of Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Approximately 10% of patient develop AML after chemotherapy or radiation for unrelated disease (t-AML) and 20% have AML with an antecedent hematologic disorder (AML-MRC). CPX-351 (Vyxeos), a liposomal formulation of a fixed molar ratio (1:5) daunorubicin and cytarabine, has been approved for treatment of adults with… Read more about this study
- Who is it for?
- Ages 64 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2024to 10 Jun 2026
- 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 64 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with de novo AML, therapy-related AML or AML with myelodysplasia related changes in first remission (CR1, CRi1, CRh1 according to IWG) after CPX-351 induction with or without CPX-351 consolidation.
Who may be able to join
- Male or female subjects > 64 years of age at the time of C1J1 CPX-351
- de novo AML including t-AML or AML-MRC according to WHO 2016
- Should have undergone induction therapy with CPX-351 with or without CPX-351 consolidation
- Patients in first line of treatment
- Should have achieved first CR/CRi/CRh status according to IWG criteria
- ECOG performance status of 0,1,2,3
Who cannot join
- Prior bone marrow or stem cell transplantation
- patients having achieved CR/CRi following an added therapy
- Patients alive at the start of the study who did not receive study information or who objected to the collection of data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maintenance Treatment With Oral Azacitidine for Patients With de Novo AML Including t-AML and AML-MRC in First Remission After CPX-351
Approximately 10% of patient develop AML after chemotherapy or radiation for unrelated disease (t-AML) and 20% have AML with an antecedent hematologic disorder (AML-MRC). CPX-351 (Vyxeos), a liposomal formulation of a fixed molar ratio (1:5) daunorubicin and cytarabine, has been approved for treatment of adults with newly diagnosed t-AML or AML-MRC. CPX-351 significantly improved median overall survival.
Although induction chemotherapy results in remission in many older patients with AML, relapse is common and overall survival is poor. For patients not eligible for HSCT, maintenance therapies are needed to reduce the risk of relapse and prolong overall survival without causing undue adverse effects or compromising health-related quality of life. Oral azacitidine (ONUREG) has been approved by FDA on September, 2020, to treat adult patients with AML who achieved CR or CRi following intensive induction chemotherapy with or without consolidation and who are not able to complete intensive curative therapy (not candidate to HSCT).
Read more
The use of oral azacitidine maintenance is an integral part of clinical practice for AML patients who have achieved a first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after intensive ""3+7"" induction chemotherapy and who are unable to complete intensive curative therapy.
But there are few data on its efficacy as a post-CPX-351 maintenance agent in patients with newly diagnosed t-AML or AML-MRC or de novo AML.THe aim of this study is to show the improvement of overall survival with use of oral Azacitidine as maintenance for patients with de novo AML including t-AML or AML-MRC who achieved complete remission or complete remission with incomplete blood count recovery after CPX-351. Long-term product safety is also being studied
- Conditions
- Acute Myeloid Leukemia
- Being tested
- No intervention
- Keywords
- ONUREG, AML de novo
- 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
Follow-up of disease
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
evalute overal survival
Measured: from first administration of ONUREG to death from any cause, assessed up to 60 moths
Secondary outcomes (1)
Safety and tolerance
number of patients with treatment related adverse events assessed by CTCAE v4.0 including clinical parameters and biological parameters
Measured: from first administration of ONUREG to death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start11 Oct 2024
- Primary completion1 Oct 2025
- Study completion10 Jun 2026
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 Centre Hospitalier Universitaire de NiceThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349239
- Sponsor's protocol ID
- 24Hemato01
- Acronym
- ORAZ-351
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2024
- Last updated
- 26 Jun 2026
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Treatment With Oral Azacitidine for Patients With de Novo AML Including t-AML and AML-MRC in First Remission After CPX-351
- ClinicalTrials.gov ID
- NCT06349239
- Acronym / sponsor ID
- ORAZ-351 / 24Hemato01
- Conditions
- Acute Myeloid Leukemia
- Keywords
- ONUREG, AML de novo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 5 Apr 2024 (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.
Approximately 10% of patient develop AML after chemotherapy or radiation for unrelated disease (t-AML) and 20% have AML with an antecedent hematologic disorder (AML-MRC). CPX-351 (Vyxeos), a liposomal formulation of a fixed molar ratio (1:5) daunorubicin and cytarabine, has been approved for treatment of adults with newly diagnosed t-AML or AML-MRC. CPX-351 significantly improved median overall survival.
Although induction chemotherapy results in remission in many older patients with AML, relapse is common and overall survival is poor. For patients not eligible for HSCT, maintenance therapies are needed to reduce the risk of relapse and prolong overall survival without causing undue adverse effects or compromising health-related quality of life. Oral azacitidine (ONUREG) has been approved by FDA on September, 2020, to treat adult patients with AML who achieved CR or CRi following intensive induction chemotherapy with or without consolidation and who are not able to complete intensive curative therapy (not candidate to HSCT).
The use of oral azacitidine maintenance is an integral part of clinical practice for AML patients who have achieved a first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after intensive ""3+7"" induction chemotherapy and who are unable to complete intensive curative therapy.
But there are few data on its efficacy as a post-CPX-351 maintenance agent in patients with newly diagnosed t-AML or AML-MRC or de novo AML.THe aim of this study is to show the improvement of overall survival with use of oral Azacitidine as maintenance for patients with de novo AML including t-AML or AML-MRC who achieved complete remission or complete remission with incomplete blood count recovery after CPX-351. Long-term product safety is also being studied
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 64 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with de novo AML, therapy-related AML or AML with myelodysplasia related changes in first remission (CR1, CRi1, CRh1 according to IWG) after CPX-351 induction with or without CPX-351 consolidation.
Key inclusion criteria (6 listed)
- Male or female subjects > 64 years of age at the time of C1J1 CPX-351
- de novo AML including t-AML or AML-MRC according to WHO 2016
- Should have undergone induction therapy with CPX-351 with or without CPX-351 consolidation
- Patients in first line of treatment
- Should have achieved first CR/CRi/CRh status according to IWG criteria
Key exclusion criteria (3 listed)
- Prior bone marrow or stem cell transplantation
- patients having achieved CR/CRi following an added therapy
- Patients alive at the start of the study who did not receive study information or who objected to the collection of data
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 interventionFollow-up of disease | Other | – |
Primary outcome
overall survival
Time frame: from first administration of ONUREG to death from any cause, assessed up to 60 moths
evalute overal survival
1 secondary outcome
Safety and tolerance
Time frame: from first administration of ONUREG to death from any cause, assessed up to 60 months
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 26 Jun 2026.
- 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.
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 Centre Hospitalier Universitaire de Nice 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 6 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 26 Jun 2026. 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?
overall survival (time frame: from first administration of ONUREG to death from any cause, assessed up to 60 moths). 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 26 Jun 2026.