Oral Azacitidine Maintenance Post-CPX 351 (ORAZ-351)

June 25, 2026 updated by: Centre Hospitalier Universitaire de Nice

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).

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 Overview

Status

Completed

Conditions

Acute Myeloid Leukemia

Intervention / Treatment

Other: No intervention

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Nice, France
    - Chu De Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival Time Frame: from first administration of ONUREG to death from any cause, assessed up to 60 moths	evalute overal survival	from first administration of ONUREG to death from any cause, assessed up to 60 moths

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerance Time Frame: from first administration of ONUREG to death from any cause, assessed up to 60 months	number of patients with treatment related adverse events assessed by CTCAE v4.0 including clinical parameters and biological parameters	from first administration of ONUREG to death from any cause, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2024

Primary Completion (Actual)

October 1, 2025

Study Completion (Actual)

June 10, 2026

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

24Hemato01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.