Primary Mediastinal Large B Cell LymphomaPhase 2NCT06412068
A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment
A Phase 2 study testing Combined anti-PD-1 and R-CHOP in people with Primary Mediastinal Large B Cell Lymphoma, run by Sun Yat-sen University.
Trial summary
The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Mediastinal Large B Cell Lymphoma
- What is being tested?
- Combined anti-PD-1 and R-CHOP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2026
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of PMBCL , and did not receive any previous treatment for PMBCL ;
- Predicted survival time ≥ 6 months ;
- 18-75 years ;
- IPI score 0-3；
- ECOG performance status 0-2 ;
- Clinicians judge that the patient is suitable for the treatment of primary mediastinal large B-cell lymphoma ;
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- After the patient was enrolled in the trial, other drugs that may have therapeutic effects on primary mediastinal large B-cell lymphoma were not acceptable ;
- WBC ≥ 3 × 109 / L, NE ≥ 1.5 × 109 / L, PLT ≥ 100 × 109 / L ;
- Serum creatinine ≤ 1.5mg / dL, creatinine clearance rate ≥ 50mL / min ;
- ALT, AST ≤ 3 × ULN ( normal upper limit ) ; total bilirubin ≤ 2 × ULN ;
- Sign the informed consent.
Who cannot join
- Other malignant diseases except PMBCL were diagnosed within 5 years；·Participating in other interventional clinical studies, or has received chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
- Known allergies to test drugs or any excipient component of these products；·Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation has been performed；
- Women in pregnancy or lactation；
- Severe infectious diseases, such as HIV infection, untreated active hepatitis B, active hepatitis C；
- The researchers believe that there are other potential risks that are not suitable for participation in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Single-arm, Multi-center Exploratory Study on the First-line Treatment of Primary Mediastinal Large B-cell Lymphoma ( PMBCL ) With Sintilimab Combined With R-CHOP Regimen
The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)
- Being tested
- Combined anti-PD-1 and R-CHOP
- Keywords
- primary mediastinal large B cell lymphoma, sintilimab, R-CHOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined anti-PD-1 and R-CHOPDrug
Sintilimab,200mg, d1, intravenous drip; Rituximab,375mg／㎡, d1,intravenous drip; Cyclophosphamide,750mg／㎡,d2,intravenous drip; Doxorubicin,50mg／㎡ （or Liposome doxorubicin ，40 mg／㎡）,d2,intravenous drip; Vincristine,1.4mg／㎡, d2（Maximum dose 2mg),intravenous drip; Prednisone, 60mg/ m2 , d1-d5,oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with PMBCL. | Experimental | Not described Receives: Drug: Combined anti-PD-1 and R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission (CR)
Measured: 2years
overall response rate (ORR)
The proportion of patients with a PR and CR
Measured: 2 years
Secondary outcomes (3)
overall survival (OS)
The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date
Measured: 2 years
progression survival (PFS)
The time from enrollment until tumor progression or death from any cause, whichever occurred first
Measured: 2 years
bio-marker analysis
Correlation between programmed death-ligand 1 expression and efficacy
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 posted14 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Mediastinal Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Wang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412068
- Sponsor's protocol ID
- 2024-FXY-106
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multi-center Exploratory Study on the First-line Treatment of Primary Mediastinal Large B-cell Lymphoma ( PMBCL ) With Sintilimab Combined With R-CHOP Regimen
- ClinicalTrials.gov ID
- NCT06412068
- Acronym / sponsor ID
- 2024-FXY-106
- Keywords
- primary mediastinal large B cell lymphoma, sintilimab, R-CHOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 14 May 2024 (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 multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with PMBCL. | Experimental | Drug: Combined anti-PD-1 and R-CHOP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathological diagnosis of PMBCL , and did not receive any previous treatment for PMBCL ;
- Predicted survival time ≥ 6 months ;
- 18-75 years ;
- IPI score 0-3；
- ECOG performance status 0-2 ;
Key exclusion criteria (5 listed)
- Other malignant diseases except PMBCL were diagnosed within 5 years；·Participating in other interventional clinical studies, or has received chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
- Known allergies to test drugs or any excipient component of these products；·Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation has been performed；
- Women in pregnancy or lactation；
- Severe infectious diseases, such as HIV infection, untreated active hepatitis B, active hepatitis C；
- The researchers believe that there are other potential risks that are not suitable for participation in this study.
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 |
|---|---|---|
| Combined anti-PD-1 and R-CHOPSintilimab,200mg, d1, intravenous drip; Rituximab,375mg／㎡, d1,intravenous drip; Cyclophosphamide,750mg／㎡,d2,intravenous drip; Doxorubicin,50mg／㎡ （or Liposome doxorubicin ，40 mg／㎡）,d2,intravenous drip; Vincristine,1.4mg／㎡, d2（Maximum dose 2mg),intravenous drip; Prednisone, 60mg/ m2 , d1-d5,oral administration. | Drug | Patients diagnosed with PMBCL. |
Primary outcome
complete remission (CR)
Time frame: 2years
overall response rate (ORR)
Time frame: 2 years
The proportion of patients with a PR and CR
3 secondary outcomes
overall survival (OS)
Time frame: 2 years
progression survival (PFS)
Time frame: 2 years
bio-marker analysis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combined anti-PD-1 and R-CHOP in people with Primary Mediastinal Large B Cell Lymphoma, run by Sun Yat-sen University.
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 11 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Wang, MD (+86-15920352412, wagnhua@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission (CR) (time frame: 2years). The study lists 2 primary outcomes in all. 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 14 May 2024.