AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorThe First Affiliated Hospital of Soochow University
About this trial
This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.
Eligibility criteria
Qualifiers
Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not immediate candidates for allogeneic stem cell transplant.
Aged 18-64 years.
Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.
ECOG performance status of < or = 3.
Disqualifiers
Acute promyeloid leukemia.
Patients with active central nervous system (CNS) leukemia.
Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
Patients with other progressive malignancies.
Trial design
Treatments tested in this trial
- Azacitidine
- Venetoclax
- Supportive care
Treatment groups
124 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov