Clinical trial
A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Venetoclax and Azacitidine Combined With HAAG in the Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia
Name
VA+HAAG
Description
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.
Trial arms
Trial start
2024-02-15
Estimated PCD
2026-05-30
Trial end
2026-12-30
Status
Recruiting
Phase
Early phase I
Treatment
venetoclax, azacitidine and HAAG regimen
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;
Arms:
VA combined with HAAG
Size
60
Primary endpoint
Composite complete response rate (CRc; CR+CRi)
Day 28-35 of induction course
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-05-01
1 organization
1 product
2 indications
Indication
Intermediate Risk Acute Myeloid LeukemiaIndication
Acute Myeloid Leukemia