Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06841952
Status
Not Yet Recruiting

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Conditions

  • AML, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • ATRA+Venetoclax+Azacitidine — DRUG
    Participants will receive a standard dose of azacitidine (75mg/m²/day)，venetoclax (target dose, 400 mg)，ATRA 45mg/m²/day
  • Chemotherapy drug — DRUG
    Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin).

Study Details

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.

Key Dates

Start date
Feb 15, 2025
Status verified
Feb 2025
Primary completion
Dec 15, 2028
Completion
Dec 15, 2030

Study Design

Enrollment
158 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: ATRA+VEN+AZA arm
    (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.
  • Active Comparator: DNR+ Ara-C arm
    (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.

Primary Outcome Measure

The overall response rate (ORR) after the second therapy [ 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 ]

Central Contacts

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