Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia, Bcl-2 Inhibitors, Azacytidine, Chemotherapy
Brief summary
In this prospective study, 30 newly untreated elderly patients with acute myeloid leukemia(AML) who were not suitable for standard chemotherapy were enrolled to observe the efficacy and side effects of venetoclax (VEN) combined with azacytidine (AZA) and chemotherapy in newly treated elderly patients with AML. Overall survival (OS), complete remission rate/complete remission with incomplete recovery of blood cell count (CR/ CRi) were used as the primary endpoints, and time to response (TTR), duration of response (DOR), mortality, and recurrence rate were used as secondary endpoints,and the incidence of adverse events were evaluated.
Detailed description
Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc. Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative. regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2, the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.
Interventions
DRUGVenetoclax
given po.
DRUGAzacitidine
given sc.
DRUGCladribine
given ivgtt.
DRUGCytarabine
given sc or ivgtt.
DRUGIdarubicin
given ivgtt.
Sponsors
LanZhou University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The elderly patients(≥ 60) with AML diagnosed according to WHO criteria; 2. Participants are ineligible for induction regimen; 3. The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3; 4. The patients and their families agree and sign the informed consent form.
Exclusion criteria
1. Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs); 2. Infiltration of the central nervous system; 3. Drugs use history affecting CYP3A within 7 days before enrollment; 4. participants considered by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | up to 16 months. | Overall survival will be defined as the number of days from the date of first dose to the date of death. |
| CR/CRi | up to 16 months. | To assess the percentage of patients achieving CR/CRi according to the International Working Group criteria for AML. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | up to 16 months. | The proportion of patients from enrollment to death was recorded. |
| Time to response | up to 16 months. | To assess the percentage of patients achieving CR/CRi or partial remission (PR) according to the International Working Group criteria for AML. |
| Adverse events | Adverse events were assessed weekly during the first and second cycles, and every two cycles thereafter (each cycle is 28 days), up to 16 months. | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. |
| Recurrence rate | up to 16 months. | Record the proportion of patients with recurrence in the study. |
| Duration of response | up to 16 months. | Duration of response will be defined as the number of days from the date of first response per the IWG criteria for AML to the earliest recurrence or progressive disease. |
Countries
China
Contacts
Primary ContactLong Zhao, M.M.
Outcome results
None listed