AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

Soochow University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Acute Myeloid Leukemia (AML) in Remission

Treatments: Other: Supportive care; Drug: Venetoclax; Drug: Azacitidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05404906

SZ-AML124

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. Aged 18-64 years.

3. Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.

4. ECOG performance status of < or = 3.

5. Adequate organ function as follows:

   1. Serum total bilirubin < or = to 3 X the Upper Limit of Normal (ULN)
   2. Aspartate Transaminase and alanine transaminase < or = to 3 x ULN
   3. Ccr（Creatinine Clearance Rate) > or ＝60 ml/min
   4. Left ventricular ejection fraction > or ＝50% determined by ultrasound.

6. For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.

7. For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.

8. Ability to understand and sign informed consent.

Exclusion criteria

1. Acute promyeloid leukemia.
2. Patients with active central nervous system (CNS) leukemia.
3. Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
4. Patients with other progressive malignancies.
5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
6. Patients who have participated in other trials within 30 days before signing the informed consent.
7. Females who are pregnant or lactating or intending to become pregnant during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Treatment (azacytidine+venetoclax)

Experimental group

Description:

Participants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles.

Treatment:

Drug: Azacitidine

Other: Supportive care

Drug: Venetoclax

Comparator ( best supportive care)

Experimental group

Description:

Participants will receive observation and supportive care during remission.

Treatment:

Other: Supportive care