Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia

Recruiting now · Not applicable

Conditions studied: Acute Lymphoblastic Leukemia, Adult

In brief

This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.

Key facts

Study ID

NCT07495631

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

43

Starts

2026-04-08

Expected to finish

2030-03-01

Last updated by the study team

2026-08-10

Who can join

Age: 14 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed, previously untreated (except prednisone/hydroxyurea) Ph-negative ALL
• Age ≥14 years, ≤60 years
• ECOG performance status ≤2
• Adequate organ function (liver, kidney, cardiac)
• For patients of childbearing potential: use of effective contraception
• Willing and able to provide informed consent

You may not qualify if…

• Burkitt leukemia/lymphoma
• Acute leukemia of ambiguous lineage
• Pregnancy or lactation
• Severe uncontrolled active infection
• History of pancreatitis
• Uncontrolled diabetes (HbA1c >7.5%)
• Active gastrointestinal bleeding within 6 months
• Arterial/venous thrombosis within 6 months
• Known HIV positivity
• Severe psychiatric illness hindering compliance
• Any other condition deemed unsuitable by the investigator

Where it is running

• Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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