Oral Azacitidine Maintenance Post-CPX 351

Recruiting

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT06349239
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-29
• Last Update Submitted: 2024-03-29
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	from first administration of ONUREG to death from any cause, assessed up to 60 moths	evalute overal survival

Secondary Outcome Measures

Name	Time	Method
Safety and tolerance	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

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France