NCT06361329 Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL
| NCT ID | NCT06361329 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | ETP-ALL |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2024-04-03 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 81 participants in total. It began in 2024-04-03 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT06361329 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 75 Years, studying ETP-ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06361329 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 81 participants.
Is NCT06361329 currently recruiting?
Yes, NCT06361329 is actively recruiting participants. Visit ClinicalTrials.gov or contact First Affiliated Hospital of Zhejiang University to inquire about joining.
Where is the NCT06361329 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06361329 clinical trial?
NCT06361329 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 81 participants.