New conditioning regimen for T cell leukemia treatment before stem cell transplant
Modified TBF Regimen as Conditioning Regimen Prior to Allogeneic Hematopoietic Cell Transplantation for T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma：Phase II Study
This study is testing a new treatment plan before a stem cell transplant to see if it helps adults with T cell leukemia and lymphoma have better survival rates and fewer relapses.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 4 Years to 65 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, radiation, cyclophosphamide, fludarabine |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT05598593 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a modified conditioning regimen using cytarabine, thiotepa, fludarabine, and busulfan prior to allogeneic hematopoietic stem cell transplantation (allo-HSCT) for adult patients with T cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (LBL). The study aims to improve outcomes for high-risk patients who typically have poor prognoses due to factors like gene mutations and minimal residual disease. By utilizing this regimen, the trial seeks to enhance survival rates and reduce relapse rates compared to traditional methods. Participants will be closely monitored for their response to the treatment and overall health during the process.
Who should consider this trial
Good fit: Ideal candidates are adults under 65 years diagnosed with T-ALL/LBL who have a suitable donor for allo-HSCT.
Not a fit: Patients with severe cardiac or pulmonary insufficiencies may not benefit from this study due to the risks associated with the conditioning chemotherapy.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and reduce relapse in high-risk adult patients with T-ALL/LBL undergoing stem cell transplantation.
How similar studies have performed: While there have been successful studies using TBI-based regimens in children and young adults, this specific modified regimen for adults is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, China (Recruiting)
Study contacts
- Principal investigator: Yi Luo, M.D. — First Affilaated Hospital of Medical School of Zhejiang University
- Study coordinator: Yi Luo, M.D.
- Email: luoyijr@163.com
- Phone: +86057187233801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.