Primary Central Nervous System Lymphoma (PCNSL)Phase 2NCT07014943
High-Dose Gemcitabine, Busulfan, and Thiotepa Followed by ASCT in Primary Central Nervous System Lymphoma
A Phase 2 study testing High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy in people with Primary Central Nervous System Lymphoma (PCNSL), run by Sichuan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma (PCNSL)
- What is being tested?
- High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- relapse after stem cell transplantation;
- other uncontrolled malignancies;
- immunodeficiency;
- active infection requiring parenteral antibiotics;
- pregnant or lactation;
- severe psychiatric or psychological conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Jie Ji, MD, 86-28-85422373, jieji@scu.edu.cn
About this study
Official title: A Study of High Dose Gemcitabine, Busulfan and Thiotepa With Autologous Stem Cell Transplantation for Primary or Relapse Central Nervous System Lymphomas
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.
Read more
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.
- Being tested
- High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, busulfan and thiotepa as conditioning therapy | Experimental | 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. Receives: Drug: High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The time from stem-cell reinfusion to disease progression, relapse, or death from any cause
Measured: 2 years from ASCT
Secondary outcomes (5)
OS
The time from ASCT to death from any cause
Measured: 2 years post ASCT
non-relapse mortality (NRM)
NRM was defined as death without evidence of relapse or progression
Measured: 100 days
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.
Measured: 30 days
Non-hematological adverse events (AEs)
Measured: 2 months
Lymphoma relapse or progression
Relapse or progression was defined as lymphoma progression following ACST
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System Lymphoma (PCNSL)Studies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ji, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014943
- Sponsor's protocol ID
- GemBuTT-1.0
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of High Dose Gemcitabine, Busulfan and Thiotepa With Autologous Stem Cell Transplantation for Primary or Relapse Central Nervous System Lymphomas
- ClinicalTrials.gov ID
- NCT07014943
- Acronym / sponsor ID
- GemBuTT-1.0
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, busulfan and thiotepa as conditioning therapy | Experimental | Drug: High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapyGemcitabine (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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (6 listed)
- relapse after stem cell transplantation;
- other uncontrolled malignancies;
- immunodeficiency;
- active infection requiring parenteral antibiotics;
- pregnant or lactation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapyGemcitabine (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. | Drug | Gemcitabine, busulfan and thiotepa as conditioning therapy |
Primary outcome
PFS
Time frame: 2 years from ASCT
The time from stem-cell reinfusion to disease progression, relapse, or death from any cause
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy in people with Primary Central Nervous System Lymphoma (PCNSL), run by Sichuan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Ji, MD (86-28-85422373, jieji@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2 years from ASCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.