ETP-ALL
Conditions
Brief summary
ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients.
Interventions
Intravenous infusion
DRUGvenetoclax
Orally by mouth
DRUGCytarabine
subcutaneous injection or Intravenous infusion
DRUGG-CSF
subcutaneous injection
DRUGVindesine
Intravenous infusion
DRUGDaunorubicin
Intravenous infusion
DRUGcyclophosphamide
Intravenous infusion
DRUGDexamethasone
Intravenous infusion or orally
DRUGL-ASP
subcutaneous injection
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥14 and \<75 years old. * Diagnosed with ETP-ALL (including near-ETP ALL) before enrollment. * Newly diagnosed patients. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Expected survival of ≥3 months. * Able to undergo oral treatment with venetoclax. * No organ dysfunction that would restrict the treatment administered * Understanding of the study and signing of the informed consent form. * Men, women of childbearing potential (postmenopausal women must have been amenorrheic for at least 12 months to be considered infertile), and their partners must voluntarily use effective contraception methods as deemed appropriate by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.
Exclusion criteria
* Patients who are unable to take venetoclax by mouth; * Patients with severe heart, lung, liver, kidney, or other organ dysfunction that may restrict their participation in this trial due to diseases; * Evidence of other clinically significant uncontrolled condition(s) such as uncontrolled and/or active systemic infection (viral, bacterial or fungal) * A history of other malignant tumors within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; * Serum total bilirubin \>1.5 ULN (upper limit of normal) (excluding leukemia infiltration); ALT or AST or ALP \>5 ULN; serum creatinine \>1.5 ULN and creatinine clearance rate \<40 mL/min; LVEF \<50%; * Known HIV infection; * Known central nervous system leukemia infiltration; * Gastrointestinal diseases known to affect venetoclax absorption as judged by the investigator; * Inability to understand or comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year EFS | 1 year | 1-year event free survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CR/CRi | At the end of Cycle 1 (up to 42 days) | Complete remission/complete remission with incomplete count recovery |
| OS | through study completion, up to 3 years | Overall survival |
| MRD | At the end of Cycle 1 (up to 42 days) | Percentage of participants who converted to MRD \< 10\^-3 after the first cycle of treatment. |
| Safety of induction therapy | At the end of Cycle 1 (up to 42 days) | Adverse events |
Countries
China
Outcome results
None listed