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

ConditionPrimary Central Nervous System Lymphoma (PCNSL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-70
SponsorSichuan University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

relapse after stem cell transplantation;

other uncontrolled malignancies;

immunodeficiency;

active infection requiring parenteral antibiotics;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Gemcitabine, busulfan and thiotepa as conditioning therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

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

Time frame
2 years from ASCT

Secondary outcomes

1

OS

The time from ASCT to death from any cause

Time frame
2 years post ASCT
2

non-relapse mortality (NRM)

NRM was defined as death without evidence of relapse or progression

Time frame
100 days
3

Hematopoietic recovery

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.

Time frame
30 days
4

Non-hematological adverse events (AEs)

Time frame
2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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