Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients

High Risk Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394011
• Other study ID #: VA+HAAG
• Status: Recruiting
• Phase: Phase 2
• Start date: February 15, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: January 2024
• Source: The First Affiliated Hospital of Soochow University
• Contact: Xiaowen Tang, Ph.D
• Phone: (0086)51267780086
• Email: xwtang1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Risk Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• 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;

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite complete response rate (CRc; CR+CRi)	CRc includes complete response CR and CRi; CR was defined as < 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as<5% bone marrow blasts, either ANC<1×10^9/L or platelets<100×10^9/L, transfusion independence but with persistence of cytopenia.	Day 28-35 of induction course
Secondary	Partial remission (PR)	PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.	Day 28-35 of induction course
Secondary	Number of adverse events	adverse events are evaluated with CTCAE V5.0.	2 years
Secondary	Relapse-free survival (RFS)	time from clinical CRc (CR and CRi) to the first relapse or death	3 years
Secondary	Overall survival (OS)	time from the first day of treatment to death or lost to follow-up for any cause.	3 years