Diffuse Large B-Cell LymphomaNCT07072208
Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
A study testing Induction therapy-Pro regimen and Consolidation therapy-Pro-pola regimen in people with Diffuse Large B-Cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of the Pro-Pola （Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Induction therapy-Pro regimen and Consolidation therapy-Pro-pola regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 May 2027
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥70 years unfit or frail
- There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.
- Histologically confirmed treatment-naive DLBCL.
- Life expectancy is>3 months.
- appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: Serum creatinine clearance ≥30mL/min; Lung function: SPO2 >90% without oxygen inhalation
- Adequate bone marrow reserve is defined as:
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- Hemoglobin ≥8g/dL, platelet count ≥75×10^9/L, Absolute neutrophil value ≥1.0×10^9/L, If accompanied by bone marrow invasion, platelet count ≥50×10^9/L, absolute neutrophil count ≥0.75×10^9/L.
- Patients have the ability to understand and are willing to provide written informed consent.
- Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.
Who cannot join
- Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal);
- Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);
- Uncontrolled active infection;
- Co-existence of other tumors requiring treatment or intervention;
- DLBCL involving central nervous system;
- Current or expected need for systemic corticosteroid treatment;
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- Previous or current history of vascular embolism;
- Other psychological conditions that prevent the patient from participating in the study or signing informed consent.
- In the investigator's judgment, it is unlikely that the subject will complete all protocol-required study visits or procedures, including follow-up visits, or will not meet the requirements for participation in the study.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Zhengming Jin, 67781856, jinzhengming519519@163.com
Changju Qu, 67781856, qcj310@163.com
About this study
Official title: A Prospective and Exploratory Clinical Study of Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
To evaluate the efficacy and safety of the Pro-Pola （Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
Read the detailed description
The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients with a lesion reduction of ≥25% received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Induction therapy-Pro regimen, Consolidation therapy-Pro-pola regimen
- Keywords
- Polatuzumab vedotin, pomalidomide, rituximab, Diffuse Large B-Cell Lymphoma, elderly patients, orelabrutinib
- 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.
Induction therapy-Pro regimenDrug
Pro regimen induction(21days per cycle*1 cycle)
- Pomalidomide 4mg per tablet 4mg orally from Days 1 to 7 of each cycle
- Rituximab 100mg per vial 375mg/m2, intravenous drip, Day 1 of each cycle
- Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle
Consolidation therapy-Pro-pola regimenDrug
Pro-pola regimen consolidation(21days per cycle*6 cycle) -Pomalidomide 4mg per tablet 4mg orally from Days 1 to 7 of each cycle -Rituximab 100mg per vial 375mg/m2, intravenous drip, Day 1 of each cycle -Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle -Polatuzumab vedotin 30mg per vial 1.8 mg/kg, intravenous drip, Day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Pro-pola regimen | Experimental | The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients not achieving mRR (defined as complete remission [CR], partial remission [PR], and mini response [miniR; lesion reduction: 25.0%-50.0%]) were withdrawn from the study. Patients achieving mRR (with a lesion reduction of ≥25%) received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles. Receives: Drug: Induction therapy-Pro regimen; Drug: Consolidation therapy-Pro-pola regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate(CRR)
The rate of patients who achieved CR after 6 cycles of Pro-pola regimen
Measured: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)
Secondary outcomes (4)
Objective response rate(ORR)
The rate of patients who achieved CR or PR after 6 cycles of Pro-pola regimen
Measured: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)
2-year progression-free survival(PFS)
PFS will be assessed from the start of the treament to date of progression, relapse, death or end of follow-up.
Measured: From the enrollment to 2-year after the treatment of last patient
2-year overall survival(OS)
OS will be assessed from the start the treatment to date of death or end of follow-up.
Measured: From the enrollment to 2-year after the treatment of last patient
Main adverse reactions
The safety of the therapeutic regimen measured by the major adverse events.
Measured: From the enrollment to 1 months after 6 cycles of Pro-pola regimen of the last patient (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Nov 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhengming Jin, Study chair, The First Affiliated Hospital of Soochow UniversityChangju Qu, Study director, The First Affiliated Hospital of Soochow UniversityNana Ping, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072208
- Sponsor's protocol ID
- 2024471
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Exploratory Clinical Study of Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
- ClinicalTrials.gov ID
- NCT07072208
- Acronym / sponsor ID
- 2024471
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- Polatuzumab vedotin, pomalidomide, rituximab, Diffuse Large B-Cell Lymphoma, elderly patients, orelabrutinib
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 18 Jul 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.
To evaluate the efficacy and safety of the Pro-Pola （Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
Detailed description
The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients with a lesion reduction of ≥25% received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pro-pola regimen | Experimental | Drug: Induction therapy-Pro regimen, Drug: Consolidation therapy-Pro-pola regimenThe study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients not achieving mRR (defined as complete remission [CR], partial remission [PR], and mini response [miniR; lesion reduction: 25.0%-50.0%]) were withdrawn from the study. Patients achieving mRR (with a lesion reduction of ≥25%) received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Age ≥70 years unfit or frail
- There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.
- Histologically confirmed treatment-naive DLBCL.
- Life expectancy is>3 months.
- appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: Serum creatinine clearance ≥30mL/min; Lung function: SPO2 >90% without oxygen inhalation
Key exclusion criteria (9 listed)
- Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal);
- Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);
- Uncontrolled active infection;
- Co-existence of other tumors requiring treatment or intervention;
- DLBCL involving central nervous system;
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 |
|---|---|---|
| Induction therapy-Pro regimenPro regimen induction(21days per cycle*1 cycle) * Pomalidomide 4mg per tablet 4mg orally from Days 1 to 7 of each cycle * Rituximab 100mg per vial 375mg/m2, intravenous drip, Day 1 of each cycle * Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle | Drug | Pro-pola regimen |
| Consolidation therapy-Pro-pola regimenPro-pola regimen consolidation(21days per cycle*6 cycle) -Pomalidomide 4mg per tablet 4mg orally from Days 1 to 7 of each cycle -Rituximab 100mg per vial 375mg/m2, intravenous drip, Day 1 of each cycle -Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle -Polatuzumab vedotin 30mg per vial 1.8 mg/kg, intravenous drip, Day 1 of each cycle | Drug | Pro-pola regimen |
Primary outcome
Complete response rate(CRR)
Time frame: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)
The rate of patients who achieved CR after 6 cycles of Pro-pola regimen
4 secondary outcomes
Objective response rate(ORR)
Time frame: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)
2-year progression-free survival(PFS)
Time frame: From the enrollment to 2-year after the treatment of last patient
2-year overall survival(OS)
Time frame: From the enrollment to 2-year after the treatment of last patient
Main adverse reactions
Time frame: From the enrollment to 1 months after 6 cycles of Pro-pola regimen of the last patient (each cycle is 21 days)
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 18 Jul 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.
Zhengming Jin study chair
The First Affiliated Hospital of Soochow University
Changju Qu study director
The First Affiliated Hospital of Soochow University
Nana Ping principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction therapy-Pro regimen and Consolidation therapy-Pro-pola regimen in people with Diffuse Large B-Cell Lymphoma, run by The First Affiliated Hospital of Soochow 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 9 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 18 Jul 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.
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 Zhengming Jin (67781856, jinzhengming519519@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate(CRR) (time frame: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)). 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 18 Jul 2025.