A Study on the Efficacy and Safety of Venetoclax Combined With HAA Regimen in Newly Diagnosed Young AML.

Phase 1

Recruiting

• Conditions: Venetoclax; Acute Myeloid Leukemia
• Interventions: Combination Product: combination of venetoclax and HAA regimen

• Registration Number: NCT05893472
• Lead Sponsor: ZePing Zhou

Brief Summary

The purpose of this study is to investigate the efficacy and safety of the combination of venetoclax and HAA regimen in young, newly diagnosed acute myeloid leukemia patients under the age of 60.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-04-24
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-29
• Last Update Submitted: 2023-05-29
• Study First Posted: 2023-06-08
• Last Update Posted: 2023-06-08
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• The eligible subjects for enrollment in this study must meet all of the following criteria:

  1. Patients with acute myeloid leukemia (excluding APL) who meet the diagnostic criteria of the World Health Organization (WHO) 2016 classification.
  2. Patients with AML and multilineage dysplasia (MDS) and/or myeloproliferative neoplasms (MPN) who meet the WHO criteria without prior history of MDS or MPN.
  3. Patients with AML who are not classified separately according to the WHO classification, except for those with acute megakaryoblastic leukemia with bone marrow fibrosis or myeloid sarcoma.
  4. Age greater than 16 years and less than 60 years, regardless of gender.
  5. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2.
  6. Requirements for laboratory parameters (within 7 days prior to treatment initiation) include: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3 times the upper limit of normal (ULN); serum bilirubin ≤2×ULN; serum cardiac enzyme <2.0×ULN; serum creatinine ≤2.0×ULN; and echocardiogram (ECHO)-determined ejection fraction within the normal range.
  7. A signed informed consent form is required before any study-specific procedures are performed. Patients 18 years and older may sign the informed consent form themselves or have it signed by their next of kin. Patients under 18 years of age must have the informed consent form signed by their legal guardian. In consideration of the patient's medical condition, if it is not in the patient's best interest to sign the form, the legal guardian or patient's next of kin may sign the form on the patient's behalf.

Exclusion Criteria

• Subjects meeting any of the following criteria will be excluded from this study:

  1. Previously treated patients (including those who have undergone induction chemotherapy regardless of treatment response).
  2. Secondary leukemia (including therapy-related AML subtype according to the World Health Organization (WHO) classification and those with a history of MDS and/or MPD).
  3. Concomitant hematologic diseases (such as hemophilia or myelofibrosis) deemed unsuitable for inclusion by the investigator; individuals with prior abnormal blood counts are allowed to participate if they have been previously excluded from MDS and MPD.
  4. Other malignant tumors requiring treatment.
  5. Pregnant or lactating women. Female participants of childbearing potential must have a negative pregnancy test within 7 days prior to the start of the trial. Male or female participants must take contraceptive measures during the trial and for 3 years after completion of treatment.
  6. Significant abnormalities in liver or kidney function beyond the inclusion criteria.
  7. Active heart disease, defined as one or more of the following:
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  1. History of uncontrolled or symptomatic angina pectoris;

  2. Myocardial infarction within 6 months prior to enrollment;

  3. History of arrhythmia requiring medication or with severe clinical symptoms;

  4. Uncontrolled or symptomatic congestive heart failure (> NYHA class 2);

  5. Ejection fraction below the lower limit of the normal range. 8. Severe infectious diseases (e.g., unhealed tuberculosis or pulmonary aspergillosis).

  6. Participants deemed unsuitable for inclusion by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The treatment group receiving the combination of venetoclax and HAA regimen.	combination of venetoclax and HAA regimen	Received induction therapy protocol： Docetaxel (HHT) 2.5mg/㎡/day, days 3-7 Aclarubicin (Acla) 20mg/day, days 3-7 Cytarabine (Ara-c) 100mg/㎡/day, days 3-7 (given as a 24-hour infusion) Venetoclax (VEN): 100mg on day 1, 200mg on day 2, and 400mg on days 3-8.

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	up to 12 months	which evaluates the efficacy of patient induction therapy, including complete remission (CR), complete remission with incomplete blood count recovery (CRi), and morphologic leukemia-free state (MLFS)

Secondary Outcome Measures

Name	Time	Method
Minimal residual disease (MRD)	up to 12 months	MRD percentage
overall survival (OS)	up to 12 months	Overall Survival (OS) is used to evaluate all patients enrolled in a clinical trial, from the date of enrollment until death from any cause or the date of last follow-up for surviving patients.
relapse-free survival (RFS)	up to 12 months	Relapse-Free Survival (RFS) is only used to evaluate patients who achieve complete remission (CR) through reinduction therapy. RFS is defined as the time from achievement of CR until death from any cause, relapse, or the date of last follow-up.
30-day mortality rate	Within 30 days after starting the medication	The 30-day mortality rate is used to evaluate all patients enrolled in a clinical trial, and is defined as the percentage of patients who die within 30 days of starting chemotherapy.
adverse drug reactions	up to 12 months	Adverse drug reactions during chemotherapy and follow-up

Trial Locations

Locations (1)

The Second Affiliated Hospital of Kunming Medical University.; 🇨🇳 Kunming, Yunnan, China