NCT05404906RecruitingPhase 2/3
AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 31 May 2022
- Start date
- 25 Jun 2022
- Primary completion date
- Jun 2028
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05404906
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 124
- From 25 Jun 2022 to the primary completion date, Jun 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
- Patients who have participated in other trials within 30 days before signing the informed consent.
Other illness
- 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).
Other
- Acute promyeloid leukemia.
- Patients with active central nervous system (CNS) leukemia.
- Females who are pregnant or lactating or intending to become pregnant during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.