High Risk Acute Myeloid Leukemia, Intermediate Risk Acute Myeloid Leukemia
Conditions
Brief summary
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.
Detailed description
This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.
Interventions
DRUGvenetoclax, azacitidine and HAAG regimen
Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3\ 10, per os; Azacitidine:75mg/m2/d, d1\ 7, subcutaneous injection; Homoharringtonine:1mg/d, d4\ 10, intravenous infusion; Aclarubicin:10mg/d, d4\ 7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4\ 10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite complete response rate (CRc; CR+CRi) | Day 28-35 of induction course | CRc includes complete response CR and CRi; CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial remission (PR) | Day 28-35 of induction course | PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts. |
| Number of adverse events | 2 years | adverse events are evaluated with CTCAE V5.0. |
| Relapse-free survival (RFS) | 3 years | time from clinical CRc (CR and CRi) to the first relapse or death |
| Overall survival (OS) | 3 years | time from the first day of treatment to death or lost to follow-up for any cause. |
Countries
China
Contacts
Primary ContactXiaowen Tang, Ph.D
Backup ContactDepei Wu, Ph.D
Outcome results
None listed