NCT06060782

Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

Clinical Study on the Efficacy and Safety of Auto-HSCT in Adult Patients with Burkitt Lymphoma, Lymphoblastic Lymphoma, and Acute Lymphoblastic Leukemia Who Received TCCA Conditioning Regimen

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is an observational study on the efficacy and safety of auto-HSCT in adult patients with Burkitt lymphoma, lymphoblastic lymphoma, and acute lymphoblastic leukemia who received TCCA conditioning regimen. The study plans to include 28 patients who received the TCCA regimen for pre-transplantation pretreatment before auto-HSCT. Maintenance treatment will be carried out after transplantation for 1 year to observe the efficacy and safety.

Conditions

• Burkitt Lymphoma
• Lymphoblastic Lymphoma, Adult
• Acute Lymphoblastic Leukemia, Adult

Interventions

Type	Name	Description
DRUG	Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen	All enrolled patients received TCCA conditioning regimen（） before auto-HSCT: Thiotepa 5mg/kg, -8, -7 days Cyclophosphamide 40mg/kg, -6, -5 days Cladribine 5mg/m2, -4, -3, -2 days Cytarabine 2g/m2, -4, -3, -2 days

Timeline

• Start date: 2024-03-06
• Primary completion: 2026-08-31
• Completion: 2026-12-31
• First posted: 2023-09-29
• Last updated: 2025-03-06

Locations

1 site across 1 country: China