Lymphoma, Large B-Cell, DiffusePhase 3NCT04789434
PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT
A Phase 3 study testing PD-1 Inhibitor Tislelizumab maintenance therapy in people with Lymphoma, Large B-Cell, Diffuse and Transplantation, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse, Transplantation, Chemotherapy
- What is being tested?
- PD-1 Inhibitor Tislelizumab maintenance therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2021to 1 Jul 2024
- Phase
- Phase 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female, aged 18-65;
- newly-diagnosed high risk (aaipi 2-3 and aaipi 1 with large mass) DLBCL patients after autologous stem cell transplantation;
- Laboratory tests (blood tests, liver and renal function) meet the following requirements:
- Blood tests: white blood cell count ≥ 3.0 × 109 / L, absolute neutrophil count ≥ 1.5 × 109 / L, hemoglobin ≥ 90g / L, platelet ≥ 75 × 109 / L
- Liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5 × upper limit of normal value;
- Renal function: serum creatinine 44-133 mmol / L;
- The score of ECOG was 0-2;
- The subject or his legal representative must provide written informed consent before the special examination or procedure of the study.
Who cannot join
- Pregnant or lactating women;
- Severe complications or infection;
- Lymphoma involving central nervous system;
- Participate in other clinical trials at the same time;
- According to the judgment of the researcher, the patients who are not suitable for this study were selected.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200020
Weili Zhao, +862164370045, zwl_trial@163.com
About this study
Official title: PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT: A Multicenter, Randomized Controlled Clinical Study on Efficacy and Safety
This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT).
Read the detailed description
This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT). 94 patients were randomly divided into two groups according to the ratio of 1:1. The whole trial included screening period (day-28 to day-1), treatment period (Tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the enrollment).
- Being tested
- PD-1 Inhibitor Tislelizumab maintenance therapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 Inhibitor Tislelizumab maintenance therapyDrug
PD-1 Inhibitor Tislelizumab maintenance therapy, 200mg, every 2 months, 12 times
| Study group | Role | What they receive |
|---|---|---|
| PD-1 Inhibitor maintenance | Experimental | PD-1 Inhibitor Tislelizumab maintenance therapy dose：200mg frequency：1 time for 2 months duration：2 years Receives: Drug: PD-1 Inhibitor Tislelizumab maintenance therapy |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Measured: 2-years after enrollment
Secondary outcomes (2)
complete remission rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: 2-years after enrollment
overall survival
Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Measured: 2-years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start9 Jul 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789434
- Sponsor's protocol ID
- NHL-PD1-1
- Status last verified
- Nov 2021
- First submitted
- 6 Mar 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT: A Multicenter, Randomized Controlled Clinical Study on Efficacy and Safety
- ClinicalTrials.gov ID
- NCT04789434
- Acronym / sponsor ID
- NHL-PD1-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 9 Mar 2021 (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.
This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT).
Detailed description
This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT). 94 patients were randomly divided into two groups according to the ratio of 1:1. The whole trial included screening period (day-28 to day-1), treatment period (Tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the enrollment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 Inhibitor maintenance | Experimental | Drug: PD-1 Inhibitor Tislelizumab maintenance therapyPD-1 Inhibitor Tislelizumab maintenance therapy dose：200mg frequency：1 time for 2 months duration：2 years |
| No intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female, aged 18-65;
- newly-diagnosed high risk (aaipi 2-3 and aaipi 1 with large mass) DLBCL patients after autologous stem cell transplantation;
- Laboratory tests (blood tests, liver and renal function) meet the following requirements:
- The score of ECOG was 0-2;
- The subject or his legal representative must provide written informed consent before the special examination or procedure of the study.
Key exclusion criteria (5 listed)
- Pregnant or lactating women;
- Severe complications or infection;
- Lymphoma involving central nervous system;
- Participate in other clinical trials at the same time;
- According to the judgment of the researcher, the patients who are not suitable for this study were selected.
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 |
|---|---|---|
| PD-1 Inhibitor Tislelizumab maintenance therapyPD-1 Inhibitor Tislelizumab maintenance therapy, 200mg, every 2 months, 12 times | Drug | PD-1 Inhibitor maintenance |
Primary outcome
progression-free survival
Time frame: 2-years after enrollment
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
2 secondary outcomes
complete remission rate
Time frame: 2-years after enrollment
overall survival
Time frame: 2-years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PD-1 Inhibitor Tislelizumab maintenance therapy in people with Lymphoma, Large B-Cell, Diffuse and Transplantation, run by Ruijin Hospital 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 8 inclusion and 5 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 22 Nov 2021. 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 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 Weili Zhao, doctor (+862164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 2-years after enrollment). 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 22 Nov 2021.