A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients

Last updated: August 11, 2024
Sponsor: Hematology department of the 920th hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

Venetoclax in combination with azacitidine and CAG

Clinical Study ID

NCT05662956
KMHD-01
  • Ages 18-65
  • All Genders

Study Summary

This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG(VA-CAG) as induction regimen in newly diagnosed young patients with acute myeloid leukemia(AML).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients ≥ 18 years old and ≤ 65 years old

  2. Newly diagnosed as AML patients according to 2016 World Health Organization (WHO)classification;

  3. Patients without receiving prior therapy for AML;

  4. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;

  5. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartateaminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN

  6. Renal function:Ccr(Creatinine Clearance Rate) ≧30 ml/min; Scr (serum creatinine) ≦2ULN

  7. Heart function: left ventricular ejection fraction ≧45%

  8. Patients must participate in this clinical trial voluntarily and sign an informedconsent form.

Exclusion

Exclusion Criteria:

  1. Acute promyeloid leukemia;

  2. AML with central nervous system (CNS) infiltration;

  3. Patients have received prior hypomethylating agents (HMA) therapy formyelodysplastic syndrome (MDS) and progressed to AML;

  4. Patients with a life expectancy <3 months

  5. Patients with uncontrolled active infection;

  6. HIV infection;

  7. Evidence of other clinically significant uncontrolled condition(s) including, butnot limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiringtreatment; b) An active second cancer that requires treatment within 6 months ofstudy entry.

  8. Female who are pregnant, breast feeding or childbearing potential.

  9. Patients deemed unsuitable for enrollment by the investigator.

Study Design

Total Participants: 104
Treatment Group(s): 1
Primary Treatment: Venetoclax in combination with azacitidine and CAG
Phase: 1/2
Study Start date:
December 01, 2022
Estimated Completion Date:
September 15, 2024

Study Description

This is an open-label, multicenter, phase II clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine (VA) and CAG (G-CSF priming, low dose cytarabine, and aclarubicin) as induction regimen in newly diagnosed patients with acute myeloid leukemia (AML).

The combination of venetoclax and azacitidine is the standard therapy for elderly (> 60 year old) patients with newly diagnosed AML who are not eligible for intensive chemotherapy. Previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo AML patients with high complete remission rates and good tolerance. The preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for newly diagnosed young patients with AML. Thus, this phase II clinical trial is going to further explore its efficacy and safety. It is expected that about 100 patients will take part in this trial.

Connect with a study center

  • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    Kunming, Yunnan 650000
    China

    Active - Recruiting

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