Actively Recruiting
Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-01
100
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.
CONDITIONS
Official Title
Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with de novo Philadelphia chromosome-negative acute lymphoblastic leukemia according to WHO classification
- Aged between 14 and 60 years
- Male or female
- ECOG Performance Status of 0 to 2
- Adequate organ function with specific lab values: total bilirubin ≤ 1.5 times upper limit of normal; ALT and AST ≤ 2.5 times ULN or ≤ 5 times ULN if liver involvement; creatinine ≤ 1.5 times ULN; serum amylase and lipase ≤ 1.5 times ULN; alkaline phosphatase ≤ 2.5 times ULN unless tumor related; normal potassium, magnesium, and phosphorus levels
- Cardiac ejection fraction ≥ 45% by Doppler ultrasound
- Provided written informed consent before screening
You will not qualify if you...
- Burkitt lymphoma or leukemia
- Acute leukemia of ambiguous lineage
- Female patients who are pregnant or breastfeeding
- Uncontrolled serious infections that may interfere with treatment
- History of pancreatitis
- Poorly controlled diabetes with HbA1c above 7.5%
- Active gastrointestinal bleeding within the past 6 months
- History of arterial or venous thrombosis within the past 6 months
- Known HIV infection
- Serious psychiatric illness that may interfere with treatment completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 300020
Actively Recruiting
Research Team
J
Jianxiang Wang, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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