NCT06349239: ORAZ-351

Oral Azacitidine Maintenance Post-CPX 351

Status unknown Last updated 5 April 2024

What this trial tests

trial testing No intervention in Acute Myeloid Leukemia in 100 participants. Status unknown.

Timeline

1 January 2020

Primary endpoint
1 January 2025

1 January 2025

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 January 2020
Primary completion	1 January 2025
Estimated completion	1 January 2025
Sites	1 location across France

Drugs / interventions tested

• No intervention

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

64 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Acute Myeloid Leukemia in Older Patients: From New Biological Insights to Targeted Therapies.
   Niscola P, Gianfelici V, Catalano G, Giovannini M, et al · · 2024 · cited 10× · PMID 39590121 · DOI 10.3390/curroncol31110490