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

ConditionAML, Adult
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with Acute Promyelocytic Leukemia (APL).

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: ATRA+VEN+AZA armExperimental treatment 1 intervention
Group B: DNR+ Ara-C armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: