Acute Myeloid Leukemia (AML) in RemissionPhase 2/3NCT05404906
AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
A Phase 2/3 study testing Azacitidine, Venetoclax and Supportive care in people with Acute Myeloid Leukemia (AML) in Remission, run by The First Affiliated Hospital of Soochow University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML) in Remission
- What is being tested?
- Azacitidine, Venetoclax and Supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesChina
- Study dates
- 25 Jun 2022to Jun 2030
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Adequate organ function as follows:
- Serum total bilirubin < or = to 3 X the Upper Limit of Normal (ULN)
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- Aspartate Transaminase and alanine transaminase < or = to 3 x ULN
- Ccr（Creatinine Clearance Rate) > or ＝60 ml/min
- Left ventricular ejection fraction > or ＝50% determined by ultrasound.
- For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.
- For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
- Ability to understand and sign informed consent.
Who cannot join
- 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.
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
- Patients who have participated in other trials within 30 days before signing the informed consent.
- Females who are pregnant or lactating or intending to become pregnant during the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Suning Chen, PhD, +8613814881746, chensuning@sina.com
- Recruiting
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, 215000
Suning Chen, Professor, 13814881746, chensuning@sina.com
Suning Chen, Professor
About this study
Official title: Randomized, Multicenter, Phase 3 Study of Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remissionin Younger Adults With Favorable-risk AML in First Remission After Conventional Chemotherapy
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.
- Being tested
- Azacitidine, Venetoclax, Supportive care
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called 5-Azacytidine
Given SC
VenetoclaxDrug
Also called ABT-199, GDC-0199, Venclexta
Given PO
Supportive careOther
Patients will receive disease monitoring and supportive care for any complication.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (azacytidine+venetoclax) | Experimental | Participants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles. Receives: Drug: Azacitidine; Drug: Venetoclax; Other: Supportive care |
| Comparator ( best supportive care) | Experimental | Participants will receive observation and supportive care during remission. Receives: Other: Supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS)
RFS is defined as the number of days from CR/CRi to the date of relapse or the date of death from any cause, whichever comes first.
Measured: From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years
Secondary outcomes (5)
Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion
The MRD conversion rate is defined as the percentage of participants deemed MRD positive (≥ 10^-3) at study initiation who converted to MRD of < 10^-3 in the bone marrow after randomization or initiation of treatment.
Measured: Measured From Baseline to approximately 3 years
Complete remission duration (CRd)
CRd is defined as time from CR/CRi until date of confirmed relapse
Measured: From date of CR/CRi to approximately 3 years
Overall Survival (OS)
OS is defined as the number of days from the date of study treatment to the date of death.
Measured: Time from treatment to death from any cause, up to approximately 3 years
Event free survival (EFS)
EFS is defined as time from the start of study treatment until date of first confirmed relapse, withdrawal from study due to adverse event, or death due to any cause,
Measured: Time from treatment to relapse，withdrawal from study due to adverse event and death from any cause, up to approximately 3 years
Incidence of adverse events
The NCI Common Toxicity Criteria (CTCAE 5.0) is used to grade adverse events.
Measured: Time from treatment to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start25 Jun 2022
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML) in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Suning, The First Affiliated Hospital of Soochow University
- Investigators
- Suning Chen, Principal investigator, First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404906
- Sponsor's protocol ID
- SZ-AML124
- Status last verified
- Aug 2022
- First submitted
- 31 May 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No