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NCT06394011RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 1 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
27 Apr 2024
Start date
15 Feb 2024
Primary completion date
30 May 2026
Lead sponsor
The First Affiliated Hospital of Soochow University
NCT number
NCT06394011

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 15 Feb 2024 to the primary completion date, 30 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with a second malignancy requiring treatment.
  • Patients with uncontrolled active infection.
  • Patients with HIV infection.
  • Patients with active hepatitis B or hepatitis C infection.

Lab values

  • Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
  • Patients with hepatic and renal inadequacy: total serum bilirubin \>=2.0 mg/dl, AST \>=3 times ULN, serum creatinine clearance (Ccr) \<50 ml / min.

Other

  • AML transformed with chronic myelogenous leukemia.
  • Acute promyelocytic leukemia (type M3).
  • Patients with arterial oxygen saturation (SpO 2) was \<95%.
  • Patients with other commodities that the investigators considered not suitable for the enrollment.

Who the study is looking for

  • Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
  • Age 18-65.
  • ECOG score: 0-2.
  • No history of previous chemotherapy or target therapy.
  • 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;
  • Creatinine clearance rate \>=30 mL/min;
  • Serum lipase \<= 1.5 times ULN, amylase \<= 1.5 times ULN;
  • Capable to understand and willing to participate in this study, signed the informed consent form.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Soochow University
Coordinator of this site? Confirm its status
SuzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.