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

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Apr 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults who have recently been diagnosed with acute myeloid leukemia (AML), specifically those with intermediate and high-risk forms of the disease. The trial is testing a combination of two medications, VA and HAAG, to see how effective and safe this treatment is in helping patients respond to their leukemia during the initial phase of treatment.

To be eligible for this study, participants must be between 18 and 65 years old and have been recently diagnosed with intermediate or high-risk AML, as defined by the World Health Organization. They should not have received any previous chemotherapy or targeted therapy and must meet certain health criteria to ensure they are suitable for the trial. If someone joins the study, they can expect regular check-ups and monitoring to assess how well the treatment works and to track any side effects. It's important for potential participants to understand that they will need to provide their consent and must be able to understand the study details before enrolling.

Gender

ALL

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.