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NCT Number: NCT07014943

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

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.

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Key information

Conditions

Primary Central Nervous System Lymphoma (PCNSL)

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location status: Recruiting

Location contact

Jie Ji, MD

CONTACT

[email protected]

86-28-85422373

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18 and 70 years;
  • CNS status of complete remission (CR) or partial response (PR) as assessed by magnetic resonance imaging (MRI), positron emission tomography-computed tomography (PET/CT), or CSF analysis (if applicable);
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2;
  • absence of systemic lymphoma in the neck, chest, abdomen, and pelvis as assessed by CT and bone marrow biopsy;
  • negative HIV and hepatitis virus infections (particularly hepatitis B or C, with HBV DNA ≥ 10,000 copies/mL);
  • left ventricular ejection fraction (LVEF) ≥50% and no uncontrolled arrythmias or symptomatic cardiac disease;
  • forced expiratory volume in one second (FEV1) ≥70%;
  • serum creatinine clearance ≥ 50 ml/min and/or serum creatinine ≤ 1.8 mg/dL;
  • serum bilirubin ≤ 2 times the upper limit of normal, serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) ≤ 3 times the upper limit of normal.

Exclusion criteria

  • relapse after stem cell transplantation;
  • other uncontrolled malignancies;
  • immunodeficiency;
  • active infection requiring parenteral antibiotics;
  • pregnant or lactation;
  • severe psychiatric or psychological conditions.

Treatment and study plan

High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy

Drug

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.

Primary outcomes

  1. PFS

    Time frame: 2 years from ASCT

    The time from stem-cell reinfusion to disease progression, relapse, or death from any cause

Secondary outcomes

  1. OS

    Time frame: 2 years post ASCT

    The time from ASCT to death from any cause

  2. non-relapse mortality (NRM)

    Time frame: 100 days

    NRM was defined as death without evidence of relapse or progression

  3. Hematopoietic recovery

    Time frame: 30 days

    Neutrophil recovery was defined as the first of three consecutive days with an absolute neutrophil count (CAN) ≥ 500/μL (0.5×109/L) after ASCT. Platelet recovery was defined as the first of three consecutive days with a platelet count ≥ 20 000/μL (20 ×109/L) without platelet transfusion for seven consecutive days.

  4. Non-hematological adverse events (AEs)

    Time frame: 2 months

  5. Lymphoma relapse or progression

    Time frame: 2 years

    Relapse or progression was defined as lymphoma progression following ACST

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Ji, MD

CONTACT

[email protected]

86-28-85422373

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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