Clinical trial NCT05805098: Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML
Official title: Venetoclax in Combination With Homoharringtonine and Cytarabine in Newly Diagnosed Subjects With Acute Myeloid Leukemia: a Phase 2/3, the Single-arm, Open-label, Monocentric Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Myeloid Leukemia
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.

Detailed description: This is a phase II/III study that seeks to treat patients ages 18-60 who have acute myeloid leukemia but have never been treated before. In order to improve the outcome of patients with primary AML, venetoclax combined with homoharringtonine and cytarabine was applied in the treatment of primary AML. This study aims to evaluate the efficacy and safety of venetoclax in combination with homoharringtonine and cytarabine in newly diagnosed subjects with AML.Depending on the level of recovery, patients will either be forced to come off study or have the option to continue the medication, receive maintenance therapy, or pursue an allogeneic stem cell transplant. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years.

Eligibility criteria: Inclusion Criteria:

1. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
2. patients must have confirmation of AML by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance \< 45 mL/min. Moderate hepatic impairment with total bilirubin \> 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
3. Patients \> 18 to ≤ 60 years
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2
5. Laboratory values meeting the following criteria:Creatinine clearance ≥ 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection, Serum aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN) 、Serum alanine aminotransferase (ALT) ≤ 3.0 × ULN (Unless considered due to leukemic organ involvement), Total bilirubin ≤ 1.5 × ULN, White blood cell (WBC) count \< 25 × 109 /L (hydroxyurea is permitted to meet this criterion)

Exclusion Criteria:

1. \> 60 years of age or \<18 years of age
2. Acute promyelocytic leukemia (M3)
3. Patient is ineligible for treatment with intensive chemotherapy
4. Patient with active infection not controlled, active bleeding from vital organs
5. Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study
6. Patient has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.
7. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen.
8. Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C
9. Patients deemed unsuitable for enrolment by the investigator.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 28 days after study treatment
Secondary outcomes:
measure: Rate of Participants With Adverse Events
timeFrame: Through 28 days post study medication administration
measure: Event-free survival
timeFrame: Through study completion, up to 3 years
measure: Overall survival
timeFrame: Through study completion, up to 3 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Qiu Huiying
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Huiying Qiu, PhD
role: STUDY_CHAIR
References: