Chemotherapy With Venetoclax and Immunotherapy for Adults With Ph-Negative Acute Lymphoblastic Leukemia
Tests chemotherapy plus venetoclax and immunotherapy in people newly diagnosed with Ph-negative acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
Key facts
- Where
- Tianjin, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 60 years old?
Source: NCT07495631, who can take part
Where in China
- Blood Diseases HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT07495631
- Record updated
- 10 August 2026
- Original description
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.Read full original descriptionShow less
A Prospective Cohort Study of a Pediatric-Inspired Chemotherapy Regimen Combined With Venetoclax and Immunotherapy for the Treatment of Adult Ph-Negative Acute Lymphoblastic Leukemia
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.
Inclusion: 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.
Exclusion: Severe uncontrolled active infection; History of pancreatitis; 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; Uncontrolled diabetes (HbA1c >7.5%); Burkitt leukemia/lymphoma; Acute leukemia of ambiguous lineage; Pregnancy or lactation.