Clinical trial NCT05807347: Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia
Official title: Phase II Trial of Venetoclax in Combination With Azacitidine and CAG as Induction Therapy in Patients With Refractory/Relapse Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Refractory/Relapse Acute Myeloid Leukemia
Lead sponsor: Hematology department of the 920th hospital
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia.

Detailed 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 Patients with Refreactory/Relapse Acute Myeloid Leukemia(AML).

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. Our preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for patients who were diagnosed with refreactory/relapse AML. Thus, this phase II clinical trial is going to further explore its efficacy and safety. It is expected that about 42 patients will take part in this trial.

Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 18 years old and ≤ 65 years old
2. Refractory/Relapse AML patients according to 2016 World Health Organization (WHO) classification;
3. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;
4. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN
5. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN
6. Heart function: left ventricular ejection fraction ≧45%
7. Patients must participate in this clinical trial voluntarily and sign an informed consent form.

Exclusion Criteria:

1. Other diseases；
2. AML with central nervous system (CNS) infiltration；
3. Patients have received prior CAG or VA regimen before；
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, but not limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. b) An active second cancer that requires treatment within 6 months of study entry
8. Female who are pregnant, breast feeding or childbearing potential.
9. Patients deemed unsuitable for enrollment by the investigator;

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: up to 2 cycles from the start of VACAG regimen (each cycle is 28 days)
Secondary outcomes:
measure: Rate of Minimal Residual Disease (MRD) negativity
timeFrame: up to 2 years
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: up to 2 years
measure: Duration of myelosuppression
timeFrame: up to 2 years
measure: Leukaemia-free survival
timeFrame: up to 2 years
measure: Overall survival
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Kunming
country: China
facility: Department of Hematology,920th Hospital of Joint Logistic Support Force of People's Liberation
state: Yunnan
Study officials:
References: