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Trial Title:
Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients
NCT ID:
NCT06394011
Condition:
Intermediate Risk Acute Myeloid Leukemia
High Risk Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
venetoclax, azacitidine and HAAG regimen
Description:
Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3~10, per os; Azacitidine:75mg/m2/d,
d1~7, subcutaneous injection; Homoharringtonine:1mg/d, d4~10, intravenous infusion;
Aclarubicin:10mg/d, d4~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4~10,
subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when
WBC counts are less than 20×10^9/L ),subcutaneous injection;
Arm group label:
VA combined with HAAG
Summary:
The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG
in the induction treatment of newly diagnosed acute myeloid leukemia.
Detailed description:
This is a single-center, single-arm, prospective clinical study in newly diagnosed
intermediate and high-risk AML patients. The patients will receive venetoclax,
azacitidine combined with HAAG regimen in the induction treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Newly diagnosed intermediate and high-risk AML according to the WHO (2022)
classification of acute myeloid leukemia (non-APL).
2. Age 18-65.
3. ECOG score: 0-2.
4. No history of previous chemotherapy or target therapy.
5. Serum total bilirubin <= 2 times the upper limit of normal (ULN), alanine
aminotransferase (ALT) <= 1.5 times ULN, aspartate aminotransferase (AST) <=1.5
times ULN;
6. Creatinine clearance rate >=30 mL/min;
7. Serum lipase <= 1.5 times ULN, amylase <= 1.5 times ULN;
8. Capable to understand and willing to participate in this study, signed the informed
consent form.
Exclusion Criteria:
1. AML transformed with chronic myelogenous leukemia.
2. Acute promyelocytic leukemia (type M3).
3. Patients with a second malignancy requiring treatment.
4. Patients with uncontrolled active infection.
5. Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade
III/IV cardiovascular dysfunction according to the New York Heart Association
Classification.
6. Patients with hepatic and renal inadequacy: total serum bilirubin >=2.0 mg/dl, AST
>=3 times ULN, serum creatinine clearance (Ccr) <50 ml / min.
7. Patients with arterial oxygen saturation (SpO 2) was <95%.
8. Patients with HIV infection.
9. Patients with active hepatitis B or hepatitis C infection.
10. Patients with other commodities that the investigators considered not suitable for
the enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaowen Tang, Ph.D
Phone:
(0086)51267780086
Email:
xwtang1020@163.com
Contact backup:
Last name:
Depei Wu, Ph.D
Phone:
(0086)51267780086
Email:
drwudepei@163.com
Start date:
February 15, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06394011
