Primary Central Nervous System LymphomaPhase 2/3NCT03733327
BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT
A Phase 2/3 study testing Busulfan (BU), Cyclophosphamide (CY) and Etoposide (VP-16) in people with Primary Central Nervous System Lymphoma and Autologous Hematopoietic Stem Cell Transplantation, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of BUCYE conditioning regimens in primary central nervous system lymphoma undergoing autologous hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma, Autologous Hematopoietic Stem Cell Transplantation, Conditioning
- What is being tested?
- Busulfan (BU), Cyclophosphamide (CY) and Etoposide (VP-16)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Nov 2018to Oct 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary central nervous system lymphoma patients
- Achieving CR or PR, then mobilizing and collecting of peripheral blood stem cells
Who cannot join
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Li Xuan, +86-020-62787883, 356135708@qq.com
Qifa Liu
About this study
Official title: Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Primary Central Nervous System Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation
The purpose of this study is to evaluate the safety and efficacy of BUCYE conditioning regimens in primary central nervous system lymphoma undergoing autologous hematopoietic stem cell transplantation.
Read the detailed description
The prognosis of patients with primary central nervous system lymphoma (PCNSL) is poor. Recent studies have demonstrated that autologous hematopoietic stem cell transplantation (auto-HSCT) could improve the prognosis of these patients. However, the optimal conditioning regimen of auto-HSCT remains unclear. In this study, the investigators evaluated the safety and efficacy of BUCYE conditioning regimens in PCNSL undergoing auto-HSCT.
- Conditions
- Primary Central Nervous System Lymphoma, Autologous Hematopoietic Stem Cell Transplantation, Conditioning
- Being tested
- Busulfan (BU), Cyclophosphamide (CY), Etoposide (VP-16)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Busulfan (BU)Drug
Busulfan was administered at 3.2 mg/kg/day on days-7 to -4.
Cyclophosphamide (CY)Drug
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Etoposide (VP-16)Drug
Etoposide was administered at 15 mg/kg/day on days -3 to -2.
| Study group | Role | What they receive |
|---|---|---|
| BUCYE | Experimental | For PCNSL patients undergoing auto-HSCT，BUCYE conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2; VP-16 15mg/kg/ day on days -3 and -2. Receives: Drug: Busulfan (BU); Drug: Cyclophosphamide (CY); Drug: Etoposide (VP-16) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
overall survival (OS)
Measured: 2 year
Secondary outcomes (3)
DFS
disease-free survival (DFS)
Measured: 2 year
relapse rate
relapse rate
Measured: 2 year
TRM
transplant-related mortality (TRM)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (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 LymphomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Guangzhou First People's Hospital, Zhujiang Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Qifa Liu, Nanfang Hospital, Southern Medical University
- Investigators
- Qifa Liu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733327
- Sponsor's protocol ID
- BUCYE-PCNSL-2018
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Primary Central Nervous System Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03733327
- Acronym / sponsor ID
- BUCYE-PCNSL-2018
- Conditions
- Primary Central Nervous System Lymphoma, Autologous Hematopoietic Stem Cell Transplantation, Conditioning
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Guangzhou First People's Hospital, Zhujiang Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- Nov 2018 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 7 Nov 2018 (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 purpose of this study is to evaluate the safety and efficacy of BUCYE conditioning regimens in primary central nervous system lymphoma undergoing autologous hematopoietic stem cell transplantation.
Detailed description
The prognosis of patients with primary central nervous system lymphoma (PCNSL) is poor. Recent studies have demonstrated that autologous hematopoietic stem cell transplantation (auto-HSCT) could improve the prognosis of these patients. However, the optimal conditioning regimen of auto-HSCT remains unclear. In this study, the investigators evaluated the safety and efficacy of BUCYE conditioning regimens in PCNSL undergoing auto-HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BUCYE | Experimental | Drug: Busulfan (BU), Drug: Cyclophosphamide (CY), Drug: Etoposide (VP-16)For PCNSL patients undergoing auto-HSCT，BUCYE conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2; VP-16 15mg/kg/ day on days -3 and -2. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Primary central nervous system lymphoma patients
- Achieving CR or PR, then mobilizing and collecting of peripheral blood stem cells
Key exclusion criteria (2 listed)
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
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 |
|---|---|---|
| Busulfan (BU)Busulfan was administered at 3.2 mg/kg/day on days-7 to -4. | Drug | BUCYE |
| Cyclophosphamide (CY)Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2. | Drug | BUCYE |
| Etoposide (VP-16)Etoposide was administered at 15 mg/kg/day on days -3 to -2. | Drug | BUCYE |
Primary outcome
OS
Time frame: 2 year
overall survival (OS)
3 secondary outcomes
DFS
Time frame: 2 year
relapse rate
Time frame: 2 year
TRM
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Qifa Liu principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Busulfan (BU), Cyclophosphamide (CY) and Etoposide (VP-16) in people with Primary Central Nervous System Lymphoma and Autologous Hematopoietic Stem Cell Transplantation, run by Nanfang Hospital, Southern Medical 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Nov 2018. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qifa Liu (+862061641611, liuqifa628@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: 2 year). 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 7 Nov 2018.