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

May 29, 2023 updated by: ZePing Zhou

The Second Affiliated Hospital of Kunming Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • The Second Affiliated Hospital of Kunming Medical University.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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:
    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).

    9. Participants deemed unsuitable for inclusion by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The treatment group receiving the 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.
Combination product: combination of venetoclax and HAA regimen
Using the combination of venetoclax and HAA regimen as induction therapy in young, newly diagnosed adult acute myeloid leukemia patients under the age of 60.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 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)
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal residual disease (MRD)
Time Frame: up to 12 months
MRD percentage
up to 12 months
overall survival (OS)
Time Frame: 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.
up to 12 months
relapse-free survival (RFS)
Time Frame: 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.
up to 12 months
30-day mortality rate
Time Frame: 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.
Within 30 days after starting the medication
adverse drug reactions
Time Frame: up to 12 months
Adverse drug reactions during chemotherapy and follow-up
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZePing Zhou

Collaborators

Guizhou Provincial People's Hospital
Second Xiangya Hospital of Central South University
Tianjin People's Hospital
Taian City Central Hospital
Handan Central Hospital
Western War Zone General Hospital

Investigators

  • Study Chair: DanQi Deng, The Second Affiliated Hospital, Kunming Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEN-PJ-KE-2023-125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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