Tests tretinoin with azacitidine and venetoclax for new acute myeloid leukemia
Tests tretinoin plus azacitidine and venetoclax in adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia
Key facts
- Where
- Suzhou, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 60 with newly diagnosed acute myeloid leukemia (AML, not APL) who have not yet had induction treatment.
- Age
- 18 to 60 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML (not acute promyelocytic leukemia, APL), with a total white blood cell count of 25 × 10^9/L or lower.
- Earlier treatment
- No earlier induction therapy. Hydroxyurea and leukapheresis are allowed.
Main reasons for not taking part
- Acute promyelocytic leukemia (APL)
- Leukemia in the central nervous system or outside the bone marrow, such as the testicles
- Current or past immunodeficiency virus infection, or active hepatitis B or C
- Active or progressing other cancer, or severe infection
- Pregnant or breastfeeding
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06841952, who can take part
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaContact: Xiang ZhangNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT06841952
- Record updated
- 24 February 2025
- Original description
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.Read full original descriptionShow less
A Prospective, Two-arm, Multi-center Clinical Study of the Efficacy and Safety of Tretinoin Capsules Combined With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia
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.
Inclusion: Patients initially diagnosed with AML (excluding APL) according to WHO diagnostic criteria; Patients who have not previously received other induction therapies (excluding hydroxyurea and leukapheresis); Total white blood cell (WBC) count ≤ 25 × 10\^9/L; Ages 18 to 60 years, inclusive, with no gender restrictions; ECOG Performance Status score of 0-2; Total bilirubin ≤ 3 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 times ULN; Aspartate aminotransferase (AST) ≤ 3 times ULN; (excluding leukemia infiltration); Endogenous creatinine clearance rate ≥ 30 ml/min; Enrolled patients must be capable of understanding and willing to participate in the study, and must sign the informed consent form.
Exclusion: Patients with concomitant central nervous system leukemia or extramedullary leukemia involvement, such as testicular infiltration; Patients with current or historical immunodeficiency virus infection; Patients with active Hepatitis B or Hepatitis C infection; Patients with a history of drug allergy, including but not limited to etoposide, azacitidine, venetoclax, daunorubicin, and cytarabine; Patients with active or progressive malignant tumors or severe infections; Patients with a left ventricular ejection fraction (LVEF) of less than 30%, classified as New York Heart Association (NYHA) Class III or above, and those deemed ineligible for enrollment by the investigator; Patients with Acute Promyelocytic Leukemia (APL); Patients who are pregnant or breastfeeding; Patients who refuse to participate in the study.