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New treatment option for Acute Myeloid Leukemia (AML) in Remission
Official title AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
ClinicalTrials.gov ID: NCT05404906
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute myeloid leukemia (aml) in remission.
Also referred to as 5-Azacytidine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not...
- 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:
You likely can't join if
- 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...
- Patients who have participated in other trials within 30 days before signing the informed consent.
See the full eligibility criteria
- 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)
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.