An interventional study of ATRA+Venetoclax+Azacitidine and Chemotherapy drug in AML, Adult, sponsored by The First Affiliated Hospital of Soochow University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Other
This study was a prospective, two-arm, multicenter clinical trial to evaluate the efficacy and safety of tretinoin capsules combined with azacitidine and venetoclax in the treatment of newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax, and tretinoin may arrest cancer cell growth by demethylation, promoting cell differentiation, or killing cells, while reducing blood-related adverse effects by promoting cell differentiation.
This is a multi-center, non-controlled, open-label, Phase 3 interventional study.Young (≥18 and ≤60 years old) patients with newly diagnosed non M3, acute myeloid leukemia will receive a combination of AZA+Venetoclax+ATRA(AVA regimen) or daunorubicin +cytarabine(DA regimen) as induction treatment for 2 cycles.
According to standard procedures, patients will receive one of the following consolidation regimens separately, including the AVA regimen, or medium-dose cytarabine alone or in combination with anthracyclines regimen for 2cycle. After consolidation therapy, maintenance treatment could be given once a month for 4 times, then once every 3 months until progression.
After the second induction therapy, allogeneic hematopoietic stem cell transplantation was recommended for patients with suitable donors.
The primary endpoint is ORR after second induction therapy.Outcome measures included complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) .
3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.
This study's planned enrollment of 158 is above the median of 40 across 2,561 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 258 studies on the registry; 149 are open to participants now.
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Exclusion Criteria:
(1)Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 1 , 200mg orally for day 2, 300mg orally for day3-5, 400mg orally for day6-9,ATRA capsule 45mg/m² orally for day 11-28, every 28 days for 2 cycles or progression; (2)Consolidate therapy:AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 1 , 200mg orally for day 2, 300mg orally for day3-5, 400mg orally for day6-9,ATRA capsule 45mg/m² orally for day 11-28, every 28 days for 2 cycles or progression; (3) Maintenance therapy:ATRA 45mg/m2 orally for d1-21 every 28 days,AZA 75mg/m² per day for days 1-7.Maintenance treatment was given once a month for 4 times, then once every 3 months until progression. After the second induction therapy, allogeneic hematopoietic stem cell transplantation was recommended for patients with suitable donors.
Drug: ATRA+Venetoclax+Azacitidine
(1)Inductive therapy: Daunorubicin 60mg/m² d1-3，cytarabine100mg/m² d1-7, every 28 days for 2 cycles or progression; (2)Consolidate therapy:Intermediate-dose cytarabine alone or combined with anthracyclines is recommended (cytarabine 1.5-2g/m²), every 28 days for 2 cycles or till progression. (3) Maintenance therapy:AZA 75mg/m² per day for days 1-7 every 28 days.Maintenance treatment was given once a month for 4 times, then once every 3 months until progression. After the second induction therapy, allogeneic hematopoietic stem cell transplantation was recommended for patients with suitable donors.
Drug: Chemotherapy drug
Drug pages: Tretinoin · Venetoclax · Azacitidine
Participants will receive a standard dose of azacitidine (75mg/m²/day)，venetoclax (target dose, 400 mg)，ATRA 45mg/m²/day
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin).
The overall response rate (ORR) after the second therapy
ORR rate was defifined as patients achieving a CRc or PR
Time frame: Efficacy was assessed within 2 weeks after completion of the second course of therapy or within 1 week before the third course of therapy
The composite complete remission rate (CRc) after the second therapy
complete response (CR) plus complete response with incomplete blood count recovery (CRi)\] after 2 cycles of treatment.
Time frame: Efficacy was assessed within 2 weeks after completion of the second course of therapy or within 1 week before the third course of therapy
Composite complete response (CRc) after the first therapy
CRc rate was defifined as patients achieving a CR or CRi
Time frame: Efficacy was assessed within 2 weeks after completion of the first course of induction therapy or within 1 week before the second course of therapy
The overall response rate (ORR) after the first therapy
ORR rate was defifined as patients achieving a CRc or PR
Time frame: Efficacy was assessed within 2 weeks after completion of the first course of induction therapy or within 1 week before the second course of therapy
Rate of transfusion independence
Rate of transfusion independence (TI) , including platelet transfusion independence rate and red blood cell transfusion independence rate.
Time frame: Up to 28 days after the start of therapy
Overall Survival (OS)
(OS) refers to the length of time from randomization until the death of the patient from any cause.
Time frame: up to 2 years after the date of the last enrolled participants
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Plan to share: No
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tretinoin · Venetoclax · Azacitidine
The First Affiliated Hospital of Soochow University →