RecruitingPhase 2NCT07014943

High-Dose Gemcitabine, Busulfan, and Thiotepa Followed by ASCT in Primary Central Nervous System Lymphoma

A Study of High Dose Gemcitabine, Busulfan and Thiotepa With Autologous Stem Cell Transplantation for Primary or Relapse Central Nervous System Lymphomas

Sponsor

Sichuan University

Enrollment

34 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

Primary Central Nervous System Lymphoma (PCNSL)

Summary

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.

Eligibility

Min Age: 16 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating an intensive chemotherapy regimen (gemcitabine, busulfan, and thiotepa) followed by an autologous stem cell transplant — where your own stem cells are used to rebuild your blood system — in patients with primary central nervous system (CNS) lymphoma, a rare brain tumor, who have already responded to initial treatment. **You may be eligible if...** - You are between 18 and 70 years old - You have primary CNS lymphoma that has responded to initial treatment (complete or partial remission confirmed by MRI or PET/CT) - Your heart, lung, and kidney function are adequate - You do not have lymphoma elsewhere in the body - You are HIV-negative and do not have active hepatitis B or C **You may NOT be eligible if...** - You have previously had a stem cell transplant - You have another active cancer - You have a severe immune deficiency, active infection requiring IV antibiotics, or severe psychiatric illness - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHigh dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy

Gemcitabine (2.5 g/m²) (Days -9 and -3), Busulfan (3.2 mg/kg) (Days -9 to -7), and Thiotepa (5 mg/kg) (Days -5, -4, and -3) were all administered intravenously. Peripheral stem cells were infused on Day 0.

Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT07014943

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