Acute Lymphoblastic Leukemia
Conditions
Interventions
Study Groups:All patients were treated with azacitidine combined with venetoclax and dexamethasone
azacitidine (AZA): 75 mg/m2, days 1-7
Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg on days 3-
Sponsors
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Prior to any screening or study-specific process, the subject or his/her legally authorized representative (if permitted by local regulations) must voluntarily sign and date an informed consent form approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB). Primary refractory after induction therapy, or relapse within = 18 years.
Exclusion criteria
Exclusion criteria: Has a history of clinically significant central nervous system (CNS) lesions or has existing clinically significant CNS lesions, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, cerebral organic syndrome, psychosis. Presence of CNS or testicular active ALL. Isolated extramedullary disease. Current active autoimmune disease or history of autoimmune disease potentially involving the CNS. History of malignancy other than ALL within 5 years prior to initiation of protocol-specific therapy. Known human immunodeficiency virus (HIV) infection. Abnormal laboratory findings, defined as follows: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or alkaline phosphatase (ALP) > = 5× upper limit of normal (ULN); Total bilirubin (TBL) > = 1.5×ULN; Creatinine >= 1.5×ULN and creatinine clearance < 60 ml/min. Received autologous hematopoietic stem cell transplantation (auto-HSCT) within 6 weeks prior to initiation of treatment. Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 3 months prior to initiation of treatment. Any active acute graft-versus-host disease (GVHD), grade 2-4 (according to Glucksberg criteria) or active chronic GVHD requiring systemic therapy. Within 2 weeks prior to initiation of treatment with any systemic therapy for antiactive GVHD. Within 2 weeks prior to initiation of treatment with cancer chemotherapy. In addition, organ toxicity (excluding hematologic toxicity) from prior ALL therapy has not recovered to CTCAE <= Grade 1 in subjects. Received radiotherapy within 2 weeks prior to initiation of treatment. Currently being treated in another investigational medical device or drug study, or within 4 weeks prior to initiation of treatment in another investigational medical device or drug study. Known hypersensitivity to any of the drugs or other ingredients in the regimen. Pregnant women and women trying to conceive should not participate in the study. To the best of the subject's and investigator's knowledge, the subject may be unable to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or be unable to comply with all required study procedures. Has a history of any other clinically significant illness or has any other clinically significant illness (other than those listed above) that, in the opinion of the Investigator or Amgen physician (if consulted), may pose a risk to the subject's safety or interfere with study evaluations, procedures, or completion. Previous treatment with venetoclax.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the overall response rate at the end of induction therapy; the complete remission rate at the end of induction therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events (CTCAE 5.0) during induction therapy, including hematological and non-hematological adverse reactions.;1-year progression-free survival (PFS) rate;1-year overall survival (OS) rate; | — |
Countries
China
Contacts
Public ContactZhu Yu
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Outcome results
None listed