RecruitingPhase 2NCT06598722

BCL-2 Inhibitors Combined with the HyperCVAD Regimen for Newly Diagnosed T-lymphoblastic Leukemia/lymphoma.

The Efficacy and Safety of BCL-2 Inhibitors Combined with the HyperCVAD Regimen in the Treatment of Newly Diagnosed T-lymphoblastic Leukemia/ Lymphoma


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

206 participants

Start Date

Aug 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a BCL-2 inhibitor drug (which blocks proteins that help cancer cells survive) to the standard HyperCVAD chemotherapy regimen can improve outcomes for patients with newly diagnosed T-cell lymphoblastic leukemia or lymphoma, aggressive blood cancers affecting T-cells. **You may be eligible if...** - You are between 18 and 60 years old - You have been newly diagnosed with T-cell lymphoblastic lymphoma or leukemia (confirmed by pathology) - You have good heart, kidney, and liver function - Your expected survival is greater than 12 weeks **You may NOT be eligible if...** - You have another active cancer (with some exceptions for certain treated cancers) - You have active bacterial, viral, or fungal infection - You are HIV positive, or have active hepatitis B or C - You have uncontrolled high blood pressure or serious heart problems - You are pregnant or breastfeeding - You have known allergies to the chemotherapy drugs in this regimen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBCL-2 inhibitors combined with the HyperCVAD regimen

BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed adult T-ALL/LBL

OTHERPropensity score matching historical data

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.


Locations(1)

Shanghai General Hospital

Shanghai, China

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NCT06598722


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