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
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to improve treatment for adolescent and adult patients aged 14 to 60 years with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL). While pediatric-inspired regimens have improved outcomes, relapse remains a significant challenge. Venetoclax, an oral drug that targets B-cell lymphoma 2, is being studied alongside this regimen to enhance remission rates and reduce relapse, potentially improving overall survival. Participants receive a combination of chemotherapy drugs including vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax during induction therapy. Venetoclax dosing increases over the induction period, with additional dosing if bone marrow blasts remain high. Following induction, consolidation therapy continues with a multi-drug pediatric-inspired chemotherapy regimen combined with venetoclax. Maintenance therapy involves monthly treatments with vincristine, mercaptopurine, methotrexate, and prednisone for up to 3 years for males and 2.5 years for females. During the study, participants undergo bone marrow aspiration on day 14 of induction and are monitored for minimal residual disease (MRD) using flow cytometry after 4 weeks. Researchers will assess remission rates, survival outcomes, relapse-free survival, and adverse events over several years. Safety and disease status are closely followed up to 5 years post-registration to evaluate long-term effects and treatment success.
CONDITIONS
Brief 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 including specified liver, kidney, pancreas, electrolyte, and heart function levels
- Provided written informed consent before screening
You will not qualify if you...
- Diagnosis of Burkitt lymphoma/leukemia or acute leukemia of ambiguous lineage
- Female patients who are pregnant or breastfeeding
- Uncontrolled active serious infections
- History of pancreatitis
- Poorly controlled diabetes with HbA1c over 7.5%
- History of active gastrointestinal bleeding within the last 6 months
- History of arterial or venous thrombosis within the last 6 months
- Known HIV positive status
- Serious psychiatric illness that could interfere with treatment completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years for male participants and up to 2.5 years for female participants
Participants receive a pediatric-inspired chemotherapy regimen combined with Venetoclax, including induction, consolidation, and maintenance therapy phases.
Multiple visits including induction visits on days 1-28, consolidation cycles, and monthly maintenance visits
Duration - Up to 5 years post-registration
Participants are monitored for overall survival, relapse free survival, disease-free survival, and adverse events after treatment completion.
Periodic visits for monitoring during follow-up
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 300020
Actively Recruiting
Research Team
J
Jianxiang Wang, Dr
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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