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

Primary Purpose

Acute Myeloid Leukemia, Venetoclax

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
combination of venetoclax and HAA regimen
Sponsored by
ZePing Zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The eligible subjects for enrollment in this study must meet all of the following criteria: Patients with acute myeloid leukemia (excluding APL) who meet the diagnostic criteria of the World Health Organization (WHO) 2016 classification. Patients with AML and multilineage dysplasia (MDS) and/or myeloproliferative neoplasms (MPN) who meet the WHO criteria without prior history of MDS or MPN. 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. Age greater than 16 years and less than 60 years, regardless of gender. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2. 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. 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: Previously treated patients (including those who have undergone induction chemotherapy regardless of treatment response). 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). 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. Other malignant tumors requiring treatment. 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. Significant abnormalities in liver or kidney function beyond the inclusion criteria. Active heart disease, defined as one or more of the following: History of uncontrolled or symptomatic angina pectoris; Myocardial infarction within 6 months prior to enrollment; History of arrhythmia requiring medication or with severe clinical symptoms; Uncontrolled or symptomatic congestive heart failure (> NYHA class 2); 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.

Sites / Locations

  • The Second Affiliated Hospital of Kunming Medical University.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The treatment group receiving the combination of venetoclax and HAA regimen.

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall response rate (ORR)
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

Minimal residual disease (MRD)
MRD percentage
overall survival (OS)
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)
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
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
Adverse drug reactions during chemotherapy and follow-up

Full Information

First Posted
April 24, 2023
Last Updated
May 29, 2023
Sponsor
ZePing Zhou
Collaborators
Handan Central Hospital, Taian City Central Hospital, Tianjin People's Hospital, Guizhou Provincial People's Hospital, Second Xiangya Hospital of Central South University, Western War Zone General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05893472
Brief Title
A Study on the Efficacy and Safety of Venetoclax Combined With HAA Regimen in Newly Diagnosed Young AML.
Official Title
The Second Affiliated Hospital of Kunming Medical University
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ZePing Zhou
Collaborators
Handan Central Hospital, Taian City Central Hospital, Tianjin People's Hospital, Guizhou Provincial People's Hospital, Second Xiangya Hospital of Central South University, Western War Zone General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Venetoclax

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The treatment group receiving the combination of venetoclax and HAA regimen.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
combination of venetoclax and HAA regimen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
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)
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Minimal residual disease (MRD)
Description
MRD percentage
Time Frame
up to 12 months
Title
overall survival (OS)
Description
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.
Time Frame
up to 12 months
Title
relapse-free survival (RFS)
Description
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.
Time Frame
up to 12 months
Title
30-day mortality rate
Description
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.
Time Frame
Within 30 days after starting the medication
Title
adverse drug reactions
Description
Adverse drug reactions during chemotherapy and follow-up
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The eligible subjects for enrollment in this study must meet all of the following criteria: Patients with acute myeloid leukemia (excluding APL) who meet the diagnostic criteria of the World Health Organization (WHO) 2016 classification. Patients with AML and multilineage dysplasia (MDS) and/or myeloproliferative neoplasms (MPN) who meet the WHO criteria without prior history of MDS or MPN. 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. Age greater than 16 years and less than 60 years, regardless of gender. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2. 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. 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: Previously treated patients (including those who have undergone induction chemotherapy regardless of treatment response). 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). 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. Other malignant tumors requiring treatment. 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. Significant abnormalities in liver or kidney function beyond the inclusion criteria. Active heart disease, defined as one or more of the following: History of uncontrolled or symptomatic angina pectoris; Myocardial infarction within 6 months prior to enrollment; History of arrhythmia requiring medication or with severe clinical symptoms; Uncontrolled or symptomatic congestive heart failure (> NYHA class 2); 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZePing Zhou, Dr
Phone
18788571605
Email
zhouzeping@kmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
yaxian tan
Phone
18208821198
Email
353964619@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DanQi Deng
Organizational Affiliation
The Second Affiliated Hospital, Kunming Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiliated Hospital of Kunming Medical University.
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DanQi Deng, Dr
Phone
087165351281
Email
kycyjszx@public.km.yn.cn

12. IPD Sharing Statement

Plan to Share IPD
No
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Results Reference
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A Study on the Efficacy and Safety of Venetoclax Combined With HAA Regimen in Newly Diagnosed Young AML.

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