Menu
Recruiting NCT07014943

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

Phase II Interventional Primary Central Nervous System Lymphoma (PCNSL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy.
Who it may be relevant to
Registry conditions: Primary Central Nervous System Lymphoma (PCNSL). Basic parameters: 16 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug High 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.

Primary outcome measures

  • PFS [Time frame: 2 years from ASCT]
Secondary outcome measures (5)
  • OS [Time frame: 2 years post ASCT]
  • non-relapse mortality (NRM) [Time frame: 100 days]
  • Hematopoietic recovery [Time frame: 30 days]
  • Non-hematological adverse events (AEs) [Time frame: 2 months]
  • Lymphoma relapse or progression [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT07014943 · GemBuTT-1.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗