Actively Recruiting
Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-05-13
43
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, previously untreated Philadelphia chromosome-negative Acute Lymphoblastic Leukemia
- Age 14 years to 60 years
- ECOG performance status 0 to 2
- Adequate liver, kidney, and heart function
- Use of effective contraception for patients who can become pregnant
- Ability and willingness to provide informed consent
You will not qualify if you...
- Diagnosis of Burkitt leukemia or lymphoma
- Acute leukemia of ambiguous lineage
- Pregnancy or breastfeeding
- Severe uncontrolled active infection
- History of pancreatitis
- Uncontrolled diabetes with HbA1c greater than 7.5%
- Active gastrointestinal bleeding within the past 6 months
- Arterial or venous thrombosis within the past 6 months
- Known HIV infection
- Severe psychiatric illness impacting study compliance
- Any other condition considered unsuitable by the study investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
H
Hui Wei, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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