Actively Recruiting
High-Dose Gemcitabine, Busulfan, and Thiotepa Followed by ASCT in Primary Central Nervous System Lymphoma
Led by Sichuan University · Updated on 2025-06-11
34
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this single-arm, prospective study is to learn if high dose gemcitabine, busulfan and thiotepa with autologous stem cell transplantation to treat primary or relapse central nervous system lymphomas. It will learn about the safety and efficacy of combination therapy. The main question it aims to answer is: Efficacy and safety of the combination of high dose gemcitabine, busulfan and thiotepa as a bridging therapy to ASCT in patients with CNSL. Participants will: Take gemcitabine (2.5 g/m²) was administered intravenously (IV) on Days -9 and -3, Busulfan (3.2 mg/kg) was given IV over 3 hours on Days -9 to -7, and thiotepa (5 mg/kg) was administered IV on Days -5, -4, and -3. Peripheral stem cells were infused on Day 0. Visit the clinic for checkups and tests in accordance with the International Primary CNS Lymphoma Group (IPCG). Researchers will observe the patients receiving GemBuTT regimen as conditioning therapy in CNSL.
CONDITIONS
Official Title
High-Dose Gemcitabine, Busulfan, and Thiotepa Followed by ASCT in Primary Central Nervous System Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- CNS lymphoma status of complete remission or partial response as confirmed by MRI, PET/CT, or cerebrospinal fluid analysis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- No systemic lymphoma in neck, chest, abdomen, or pelvis confirmed by CT and bone marrow biopsy
- Negative for HIV and hepatitis viruses, especially hepatitis B or C with HBV DNA below 10,000 copies/mL
- Left ventricular ejection fraction of 50% or higher with no uncontrolled arrhythmias or symptomatic heart disease
- Forced expiratory volume in one second (FEV1) of 70% or higher
- Serum creatinine clearance of at least 50 ml/min and/or serum creatinine of 1.8 mg/dL or less
- Serum bilirubin no more than 2 times the upper limit of normal; SGOT and/or SGPT no more than 3 times the upper limit of normal
You will not qualify if you...
- Relapse after prior stem cell transplantation
- Other uncontrolled cancers
- Immunodeficiency conditions
- Active infections requiring intravenous antibiotics
- Pregnant or breastfeeding women
- Severe psychiatric or psychological disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
J
Jie Ji, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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