VHAG in Treating R/R T-ALL/LBL

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VHAG for patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (LBL), which are aggressive types of blood cancer. Even after initial treatments like chemotherapy, some patients still do not achieve complete remission, meaning their cancer symptoms do not fully go away. This trial aims to find out if VHAG can help those patients who have not responded well to previous treatments.

To participate in this study, patients need to be between the ages of 14 and 75 and must have a diagnosis of T-ALL or LBL that has either returned after treatment or has not responded to treatment at all. Participants will be monitored closely throughout the trial, and those who join will need to understand the study and provide consent. It's important to note that certain health conditions, such as severe heart or lung problems, may prevent someone from taking part in the trial. Overall, this study is an opportunity for eligible patients to potentially receive a new treatment option for their cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Before enrollment, a diagnosis of newly diagnosed T-cell acute leukemia/lymphoma.The diagnostic criteria refer to the 2022 WHO classification; 2. Age ≥ 14 years,\<75 years; 3. Clincally diagnosed as relapsed or refractory T-ALL/LBL; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Expected survival time ≥ 2 months; 6. No organ dysfunction that would restrict the use of this protocol during the screening period; 7. Understand the study and sign the informed consent form.
• Exclusion Criteria:
• • 1. Patients with known central nervous system (CNS) involvement of T-ALL/LBL; 2. Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.) 3. Cardiac ultrasound LVEF \< 45%; 4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; 5. Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN; 6. Known HIV infection; 7. Conditions affecting the use of the study drug as assessed by the investigator; 8. Inability to understand or comply with the study protocol.