Using oral azacitidine to maintain remission in older patients with acute myeloid leukemia
Maintenance Treatment With Oral Azacitidine for Patients With de Novo AML Including t-AML and AML-MRC in First Remission After CPX-351
This study is testing if a pill called oral azacitidine can help older patients with acute myeloid leukemia stay in remission longer after their initial treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 64 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Nice) |
| Trial ID | NCT06349239 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on older patients with acute myeloid leukemia (AML) who have achieved remission after treatment with CPX-351. It aims to evaluate the effectiveness of oral azacitidine (ONUREG) as a maintenance therapy to prolong overall survival and reduce the risk of relapse. The study includes patients who are not eligible for hematopoietic stem cell transplantation and have specific inclusion criteria related to their treatment history and performance status. By monitoring these patients, the study seeks to gather valuable data on the long-term benefits of this maintenance therapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 64 years old with de novo AML who have achieved remission after induction therapy with CPX-351.
Not a fit: Patients who have undergone prior bone marrow or stem cell transplantation or those who did not achieve remission after initial therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for older AML patients post-remission.
How similar studies have performed: Other studies have shown promising results with maintenance therapies in AML, but the specific use of oral azacitidine post-CPX-351 is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nice
- CHU de Nice — Nice, France (Recruiting)
Study contacts
- Study coordinator: Thomas Cluzeau, Pr
- Email: cluzeau.t@chu-nice.fr
- Phone: 0492039025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.