Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL

Conditions

• ETP-ALL

Eligibility Criteria

Sex

ALL

Age

14 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Homoharringtonine — DRUG
  Intravenous infusion
• venetoclax — DRUG
  Orally by mouth
• Cytarabine — DRUG
  subcutaneous injection or Intravenous infusion
• G-CSF — DRUG
  subcutaneous injection
• Vindesine — DRUG
  Intravenous infusion
• Daunorubicin — DRUG
  Intravenous infusion
• cyclophosphamide — DRUG
  Intravenous infusion
• Dexamethasone — DRUG
  Intravenous infusion or orally
• L-ASP — DRUG
  subcutaneous injection

Study Details

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.

Key Dates

Start date

Apr 3, 2024

Status verified

Mar 2024

Primary completion

Mar 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

81 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: VHAG group
  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
• Active Comparator: Traditional Chemotherapy Regimen group
  * VDCLP regimen * VD(/I) CP regimen * Hyper CVAD-A regimen * VDLP regimen

Primary Outcome Measure

1-year EFS [ Time Frame: 1 year ]