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

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

NCT ID: NCT06598722

Condition: Lymphoblastic Lymphoma, Adult
Lymphoblastic Leukemia, Acute T-cell

Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: BCL-2 inhibitors combined with the HyperCVAD regimen
Description: BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed adult T-ALL/LBL
Arm group label: BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed T-ALL/LBL

Intervention type: Other
Intervention name: Propensity score matching historical data
Description: 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.
Arm group label: propensity score matching with historical data

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai General Hospital

Address:
City: Shanghai
Country: China

Status: Recruiting

Start date: August 7, 2024

Completion date: August 7, 2027

Lead sponsor:
Agency: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class: Other

Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06598722