Clinical trial NCT05893472: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Venetoclax
Lead sponsor: The Second Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
Collaborators: name: Handan Central Hospital
name: Taian City Central Hospital
name: Tianjin People's Hospital
name: Guizhou Provincial People's Hospital
name: Second Xiangya Hospital of Central South University
name: Western War Zone General Hospital
First posted: 2023-06-08
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

  9. Participants deemed unsuitable for inclusion by the investigator.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: up to 12 months
Secondary outcomes:
measure: Minimal residual disease (MRD)
timeFrame: up to 12 months
measure: overall survival (OS)
timeFrame: up to 12 months
measure: relapse-free survival (RFS)
timeFrame: up to 12 months
measure: 30-day mortality rate
timeFrame: Within 30 days after starting the medication
measure: adverse drug reactions
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University.
state: Yunnan
Study officials:
affiliation: The Second Affiliated Hospital, Kunming Medical University
name: DanQi Deng
role: STUDY_CHAIR
References:
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