Clinical trial NCT07014943: High-Dose Gemcitabine, Busulfan, and Thiotepa Followed by ASCT in Primary Central Nervous System Lymphoma
Official title: A Study of High Dose Gemcitabine, Busulfan and Thiotepa With Autologous Stem Cell Transplantation for Primary or Relapse Central Nervous System Lymphomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Primary Central Nervous System Lymphoma (PCNSL)
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. age between 18 and 70 years;
2. 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);
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2;
4. absence of systemic lymphoma in the neck, chest, abdomen, and pelvis as assessed by CT and bone marrow biopsy;
5. negative HIV and hepatitis virus infections (particularly hepatitis B or C, with HBV DNA ≥ 10,000 copies/mL);
6. left ventricular ejection fraction (LVEF) ≥50% and no uncontrolled arrythmias or symptomatic cardiac disease;
7. forced expiratory volume in one second (FEV1) ≥70%;
8. serum creatinine clearance ≥ 50 ml/min and/or serum creatinine ≤ 1.8 mg/dL;
9. 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:

1. relapse after stem cell transplantation;
2. other uncontrolled malignancies;
3. immunodeficiency;
4. active infection requiring parenteral antibiotics;
5. pregnant or lactation;
6. severe psychiatric or psychological conditions.

Primary outcomes:
measure: PFS
timeFrame: 2 years from ASCT
Secondary outcomes:
measure: OS
timeFrame: 2 years post ASCT
measure: non-relapse mortality (NRM)
timeFrame: 100 days
measure: Hematopoietic recovery
timeFrame: 30 days
measure: Non-hematological adverse events (AEs)
timeFrame: 2 months
measure: Lymphoma relapse or progression
timeFrame: 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: