Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL
Phase 3
Recruiting
- Conditions
- Interventions
- Registration Number
- NCT06361329
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- 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, multi...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 81
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traditional Chemotherapy Regimen group Cytarabine * VDCLP regimen * VD(/I) CP regimen * Hyper CVAD-A regimen * VDLP regimen Traditional Chemotherapy Regimen group Vindesine * VDCLP regimen * VD(/I) CP regimen * Hyper CVAD-A regimen * VDLP regimen Traditional Chemotherapy Regimen group Daunorubicin * VDCLP regimen * VD(/I) CP regimen * Hyper CVAD-A regimen * VDLP regimen Traditional Chemotherapy Regimen group cyclophosphamide * VDCLP regimen * VD(/I) CP regimen * Hyper CVAD-A regimen * VDLP regimen Traditional Chemotherapy Regimen group L-ASP * VDCLP regimen * VD(/I) CP regimen * Hyper CVAD-A regimen * VDLP regimen VHAG group Cytarabine Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28. HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count \<10\*10E9/L VHAG group Homoharringtonine Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28. HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count \<10\*10E9/L VHAG group venetoclax Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28. HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count \<10\*10E9/L VHAG group G-CSF Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28. HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count \<10\*10E9/L Traditional Chemotherapy Regimen group Dexamethasone * VDCLP regimen * VD(/I) CP regimen * Hyper CVAD-A regimen * VDLP regimen
- Primary Outcome Measures
Name Time Method 1-year EFS 1 year 1-year event free survival rate
- Secondary Outcome Measures
Name Time Method 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
CR/CRi At the end of Cycle 1 (up to 42 days) Complete remission/complete remission with incomplete count recovery
Trial Locations
- Locations (1)
The First Affiliated Hospital, College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China