Skip to content
TrialMatch
Sign up
Recruiting Phase 2

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

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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.

Condition
Lymphoblastic Lymphoma, Adult, Lymphoblastic Leukemia, Acute T-cell
Tested
BCL-2 inhibitors combined with the HyperCVAD regimen, Propensity score matching historical data
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Who can join

Age
18 to 60 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Maximum age: 60 years
  • Study condition: Lymphoblastic Lymphoma, Adult, Lymphoblastic Leukemia, Acute T-cell
  • 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 g
  • 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

1 site, 1 recruiting

Shanghai General Hospital

Shanghai, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.