Actively Recruiting
BCL-2 Inhibitors Combined with the HyperCVAD Regimen for Newly Diagnosed T-lymphoblastic Leukemia/lymphoma.
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-09-24
206
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The experimental group included patients diagnosed with T-ALL/LBL (T-lymphoblastic leukemia/ lymphoma) at initial diagnosis, who received treatment with BCL-2 inhibitors combined with the Hyper CVAD regimen. The control group consisted of patients diagnosed with T-ALL/LBL from multiple centers, for whom basic information, disease information, treatment details, and efficacy data were collected. Propensity score matching was conducted with historical data (matching factors included age, gender, initial LDH levels, and the presence or absence of a large mediastinal mass at diagnosis) to compare the advantages and disadvantages of the experimental regimen with previous induction treatment protocols. The primary endpoint was the complete remission (CR) rate after induction chemotherapy, while secondary endpoints included duration of remission (DOR), progression-free survival (PFS), overall survival (OS), and the occurrence of adverse events. This study aims to provide a more effective and safer treatment option for patients with T-LBL.
CONDITIONS
Official Title
BCL-2 Inhibitors Combined with the HyperCVAD Regimen for Newly Diagnosed T-lymphoblastic Leukemia/lymphoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years, any gender
- Expected survival time greater than 12 weeks
- ECOG performance status score between 0 and 2
- Confirmed diagnosis of T-cell lymphoblastic lymphoma with less than 25% tumor cells in bone marrow
- Creatinine clearance of 60 mL/min or higher
- Left ventricular ejection fraction greater than 50% without significant ECG changes
- Baseline oxygen saturation above 92%
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- ALT and AST levels less than or equal to 3 times the upper limit of normal
- Ability to understand the trial and provide signed informed consent
You will not qualify if you...
- History of acute T-cell leukemia, T-cell lymphoma, or T-cell lymphoblastic lymphoma within the past 5 years except certain treated cancers
- Active bacterial, viral, or fungal infections requiring treatment and uncontrolled
- Positive for HBsAg or HBcAb with detectable HBV DNA
- Positive hepatitis C virus antibodies with detectable HCV RNA
- Positive for syphilis (TRUST test) or HIV antibodies
- Dysfunction of major organs including cardiovascular or pulmonary diseases
- History of active gastrointestinal bleeding within past 3 months
- Uncontrolled hypertension, hypertensive crisis, or hypertensive encephalopathy
- Significant cardiovascular risks including congestive heart failure, unstable angina, serious arrhythmias, recent arterial thrombosis, or symptomatic deep vein thrombosis or pulmonary embolism
- Active uncontrolled diseases interfering with trial participation
- Active or uncontrolled central nervous system diseases requiring treatment
- Pregnant or breastfeeding women or planning pregnancy within 1 year after treatment
- Known allergies to components of study drugs such as cyclophosphamide, doxorubicin, vincristine, cytarabine, or methotrexate
- Conditions compromising ability to consent or comply with study requirements
- Investigator judgment deeming participation unsafe or inappropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China
Actively Recruiting
Research Team
X
Xianmin Song，MD
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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