NCT06841952Not yet recruiting
Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia
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
Source: ClinicalTrials.gov · Last updated 24 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- First submitted
- 15 Jan 2025
- Start date
- 15 Feb 2025
- Primary completion date
- 15 Dec 2028
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06841952
What you commit to
- Study type: Interventional
- Planned participants: 158
- From 15 Feb 2025 to the primary completion date, 15 Dec 2028
- 1 site 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
- Patients with concomitant central nervous system leukemia or extramedullary leukemia involvement, such as testicular infiltration.
Other illness
- 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.
Lab values
- 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.
Other
- Patients with Acute Promyelocytic Leukemia (APL).
- Patients who are pregnant or breastfeeding.
- Patients who refuse to participate in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.