Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
Study ID
NCT06060782
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen — DRUG
    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

Study Details

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.

Key Dates

First listed
Sep 29, 2023
Start date
Mar 6, 2024
Status verified
Mar 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: subject group

Primary Outcome Measure

3-year recurrence-free survival rate [ Time Frame: 3 years after transplantation ]

Related Studies