A Single-Center Prospective Cohort Study to Evaluate the Efficacy and Safety of Intensifying Treatment with Venetoclax in Patients with Newly Diagnosed Acute Myeloid Leukemia (non-APL) and Exhibiting Lower Early Peripheral Blast Clearance Rate After Standard Intensive Induction Chemotherapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This single-center prospective cohort study aims to evaluate the efficacy and safety of Intensifying treatment with Venetoclax along with intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) except acute promyelocytic leukemia (non-APL) and exhibiting lower early peripheral blast clearance rate (EPBCR) after standard Intensive Induction therapy (3+7 regimen).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Newly diagnosed AML, except for the APL subtype, according to the 2022 World Health Organization classification (WHO 2022 criteria)

• Age ≥18 years and ≤70 years

• Eligible for intensive chemotherapy

• No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \[WBC\] counts\>25x10\^9/L)

• Eastern Cooperative Oncology Group (ECOG) performance status≤2

• Adequate renal function is defined as:

‣ Serum creatinine≤2.0×upper limit of normal (ULN)

⁃ Creatinine clearance (CrCl)\>30 mL/min calculated by the Cockcroft-Gault equation.

• Adequate hepatic and heart function is defined as:

‣ Serum total bilirubin≤1.5×ULN unless considered due to Gilbert's disease, or leukemic involvement

⁃ Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP)≤2.5×ULN, unless considered due to leukemic involvement

⁃ Myocardial enzyme\<2.0×ULN

⁃ Left ventricular ejection fraction is within the normal range by measure of echocardiogram (ECHO)

• Signed a written informed consent form (ICF)

• Female participants who are of non-reproductive potential (i.e., post-menopausal by history of no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female participants of childbearing potential must have a negative serum pregnancy test upon study entry

Locations
Other Locations
China
Affiliated hospital of Nantong University
RECRUITING
Nantong
Contact Information
Primary
Yingxin Sun, Dr
syx20194132088@163.com
+86-13646249970
Time Frame
Start Date: 2024-10-31
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 83
Treatments
Experimental: Assigned interventions
Participants with EPBCR\>1.5 log (EPBCRhigh) complete the 3+7 regimen and are managed according to standard clinical practice. Participants with EPBCR≦1.5 log (EPBCRlow) receive intensified treatment with venetoclax orally along with the standard 3+7 regimen on days 5-14. A venetoclax dose ramp-up schedule is required in the first induction therapy.
Sponsors
Leads: Affiliated Hospital of Nantong University

This content was sourced from clinicaltrials.gov

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