Combining BCL-2 inhibitors with HyperCVAD for treating 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

This study is testing whether combining BCL-2 inhibitors with the HyperCVAD treatment can help people who are newly diagnosed with T-lymphoblastic leukemia or lymphoma achieve better remission rates.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: methotrexate, cyclophosphamide, doxorubicin, chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06598722 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of BCL-2 inhibitors in combination with the HyperCVAD regimen for patients newly diagnosed with T-lymphoblastic leukemia or lymphoma. Patients in the experimental group will receive this combination treatment, while a control group will be formed using historical data from similar patients. The study will assess the complete remission rate after induction chemotherapy as the primary endpoint, alongside secondary endpoints such as duration of remission, progression-free survival, overall survival, and adverse events. Propensity score matching will be utilized to ensure comparability between groups based on key clinical factors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 years with pathologically confirmed T-cell lymphoblastic lymphoma and specific health criteria.

Not a fit: Patients with a history of acute T-cell leukemia or T-cell lymphoma within the past 5 years are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved remission rates and overall survival for patients with T-lymphoblastic leukemia/lymphoma.

How similar studies have performed: While there is ongoing research in this area, the combination of BCL-2 inhibitors with the HyperCVAD regimen is a novel approach that has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria Age 18-60 years, regardless of gender; Expected survival time greater than 12 weeks; ECOG score 0-2; Pathologically or flow cytometrically confirmed as T-cell lymphoblastic lymphoma, with less than 25% tumor cell proportion in bone marrow smears;

Liver and kidney function, as well as cardiopulmonary function, meet the following requirements:

Creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 mL/min; Left ventricular ejection fraction greater than 50%, with no clinically significant ECG changes; Baseline oxygen saturation greater than 92% Total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN Able to understand the trial and has signed the informed consent form Exclusion Criteria A history of acute T-cell leukemia, T-cell lymphoma, or T-cell lymphoblastic lymphoma within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery Active bacterial, viral, or fungal infections that require treatment and are not controlled; those who are HBsAg or HBcAb positive, with peripheral blood HBV DNA ≥ the lower limit of detection; individuals who are positive for hepatitis C virus antibodies and have positive peripheral blood HCV RNA; individuals who test positive for syphilis (TRUST test); individuals who are positive for human immunodeficiency virus (HIV) antibodies Dysfunction of important organs (cardiovascular, pulmonary) or a history of active gastrointestinal bleeding within the past 3 months; individuals with uncontrolled hypertension, hypertensive crisis, or a history of hypertensive encephalopathy, and a history or evidence of significant cardiovascular risk, including any of the following: congestive heart failure, unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia); a history of arterial thrombosis within the past 3 months (e.g., stroke, transient ischemic attack); a history of symptomatic deep vein thrombosis, pulmonary embolism within the past 6 months, or a history of coronary angioplasty, defibrillation, or any clinical complications or diseases that may pose a risk to the participant\'s safety or interfere with the evaluation, procedures, or completion of the study Any uncontrolled active disease that may interfere with participation in the trial; Active, uncontrolled central nervous system diseases or a history of central nervous system disease requiring treatment (e.g., epilepsy) Pregnant or breastfeeding women; and individuals planning to become pregnant within 1 year after infusion, during treatment, or after treatment ends Presence of uncontrolled active infections (except for simple urinary tract infections or upper respiratory infections Known allergies to any components of cyclophosphamide, doxorubicin, vincristine, cytarabine, methotrexate, etc.

Any situation that the investigator believes would compromise participant safety or interfere with the study objectives, or any individual deemed inappropriate for participation by the investigator Individuals with diseases affecting their ability to sign the written informed consent form or comply with study procedures; those unwilling or unable to adhere to study requirements

Where this trial is running

Shanghai

• Shanghai General Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xianmin Song，MD

Conditions Lymphoblastic Lymphoma, Adult; Lymphoblastic Leukemia, Acute T-cell