NCT07495631Recruiting
Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
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
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 26 Feb 2026
- Start date
- 8 Apr 2026
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- NCT number
- NCT07495631
What you commit to
- Study type: Interventional
- Planned participants: 43
- From 8 Apr 2026 to the primary completion date, 1 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Uncontrolled diabetes (HbA1c \>7.5%)
Other
- Burkitt leukemia/lymphoma
- Acute leukemia of ambiguous lineage
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 14 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.