Modified TBF Regimen as Conditioning Regimen Prior to Allo-HSCT for T-ALL/LBL

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Oct 26, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Modified TBF Regimen as Conditioning Regimen Prior to Allo-HSCT for T-ALL/LBL," is studying a new treatment approach for adults with T cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL). The trial aims to see if a modified version of a chemotherapy regimen that includes cytarabine, thiotepa, fludarabine, and busulfan can help improve treatment outcomes, especially for patients at high risk of relapse. This is important because while many children with T-ALL/LBL can be cured, adults often have lower survival rates. The goal is to find a safer and more effective way to prepare patients for stem cell transplantation, which can help them achieve better long-term survival.

To participate in this trial, patients must be under 65 years old, diagnosed with T-ALL or LBL, and have a suitable donor for the stem cell transplant. They should also be in reasonably good health with specific organ function levels. Participants can expect to receive this modified treatment regimen and be closely monitored throughout the study. It's crucial for potential participants to be aware that not everyone can join the trial, especially those with severe heart, lung, liver, or kidney issues, or those with active infections. If you're interested in learning more, it's important to discuss this with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age younger than 65 years
• • 2. Patients diagnosed with T cell acute lymphoblastic leukemia/lymphoma , T-ALL/LBL according to WHO diagnostic criteria.
• • 3. Patients who have donors and plane to accept allogeneic hematopoietic stem cell transplantation treatment.
• • 4. ECOG body status score 0-2.
• • 5. Good organ function level: ANC (neutrophil absolute value \>=1.0x10\^9/ L; PLT \>=30x10\^9/L; HB \>=80g/L; Tibil \<=1.5 ULN; ALT / AST \<=2.5 ULN; bun / Cr \<=1.5 ULN; LVEF \>=50%).
• • 6. Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing.
• Exclusion Criteria:
• • 1. Patients who with severe cardiac insufficiency, cardiac ejection fraction EF is less than 60%; or severe arrhythmia, the investigator can not tolerate conditioning chemotherapy;
• • 2. In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate conditioning chemotherapy;
• • 3. Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of conditioning chemotherapy;
• • 4. In patients with severe renal insufficiency, the renal function index (CR) is more than 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinine clearance rate (CR) is less than 50ml / min, the researchers evaluated that they could not tolerate conditioning chemotherapy;
• • 5. In patients with severe active infection, the researchers evaluated that they could not tolerate conditioning chemotherapy;
• • 6. Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study.
• • 7. Other reasons why the researchers could not be selected.