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A prospective, single arm, multicenter study on the efficacy and safety of venetoclax+ HAG regimen for induction treatment in newly diagnosed adult Early T-cell precursor (ETP) acute lymphoblastic leukemia

A prospective, single arm, multicenter study on the efficacy and safety of venetoclax+ HAG regimen for induction treatment in newly diagnosed adult Early T-cell precursor (ETP) acute lymphoblastic leukemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061708
Enrollment
Unknown
Registered
2022-06-30
Start date
2022-07-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early T-cell precursor (ETP) acute lymphoblastic leukemia

Interventions

Experimental group:The V-HAG regimen included venetoclax(orally once daily,100 mg day 1, 200 mg on day 2,400mg from day 3 to day 14. If more than 5% of the blast cells in the bone marrow were present

Sponsors

The First Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged > 14 years; 2. Newly diagnosed Early T-cell precursor (ETP) acute lymphoblastic leukemia; 3. ECOG 0-2; 4. Expected survival >= 2 months; 5. During the screening period, there is no abnormal organ function that restricts the use of this regimen; 6. Understand and comply with all test protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Difficulties in the administration of oral medication or malabsorption syndrome; 2. Abnormal organ function that restricts the use of this regimen; 3. LVEF 1.5 ULN (normal upper limit); ALT, AST or ALP > 5ULN; Serum creatinine > 1.5 ULN; 6. HIV positive; 7. General condition is not suitable for chemotherapy; 8. Inability to understand or follow research protocols; 9. Subjects who received a potent or moderately potent CYP3A inducer/inhibitor within the 7 days prior to initiation of study therapy.

Design outcomes

Primary

MeasureTime frame
complete remission(CR)+CR with incomplete blood count recovery(CRi) after first induction;

Secondary

MeasureTime frame
overall survival;event-free survival;Overall CR/CRi;Safety;minimal residual disease,MRD;

Countries

China

Contacts

Public ContactJie Jin

The First Affiliated Hospital, Zhejiang University School of Medicine

jiej0503@163.com+86 135 0571 6779

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026