Diffuse Large B-cell Lymphoma (DLBCL)NCT06832228
Study of Pomalidomide Combination with Rituximab and Anti-PD-1 Antibody （PPR） in Third or Later Line Therapy of DLBCL
A study testing Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR） in people with Diffuse Large B-cell Lymphoma (DLBCL), run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study aims to observe and explore the efficacy and safety of pomalidomide combination with rituximab and Anti-PD-1 Antibody in Third or Later Line Therapy of diffuse large B-cell lymphoma (DLBCL) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma (DLBCL)
- What is being tested?
- Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Sep 2026
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily joined the study, signed the informed consent, and had good compliance;
- Patients with 18 Years to 80 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2;
- Patients with histopathologically confirmed diffuse large B-cell lymphoma with evaluable lesions who did not achieve CR or relapsed after second-line therapy
- Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.
Who cannot join
- Pathological subtypes: primary central nervous system DLBCL or primary mediastinal large B-cell lymphoma.
- Presence of severe or uncontrolled comorbid conditions including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer disease, or severe hemorrhagic disorders such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring transfusion or other medical interventions.
- A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Any active infection requiring systemic antimicrobial therapy within 14 days before starting study treatment, including, but not limited to, bacterial, fungal, and viral infections.
- Current participation in other clinical studies, or initiation of study drugs administration less than 4 weeks after completion of previous clinical study treatment.
- Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Haiyan Yang, PhD, 0571-88122192, yanghy@zjcc.org.cn
Haifeng Yu, MD, 15157155533, yuhaifeng5533@dingtalk.com
About this study
Official title: Prospective Single-center Study of Pomalidomide Combination with Rituximab and Anti-PD-1 Antibody （PPR） in Third or Later Line Therapy of Diffuse Large B-cell Lymphoma (DLBCL)
This study aims to observe and explore the efficacy and safety of pomalidomide combination with rituximab and Anti-PD-1 Antibody in Third or Later Line Therapy of diffuse large B-cell lymphoma (DLBCL)
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL)
- Being tested
- Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR）
- 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.
Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR）Drug
All patients will receive the PPR regimen (a total of 4-6 cycles, 28 days for each cycle):
- pomalidomide: 4 mg, orally, once daily from Day 1 to Day 21.
- Rituximab: 375 mg/m², administered on Day 1.
- PD-1: 200 mg, administered on Days 1.
| Study group | Role | What they receive |
|---|---|---|
| pomalidomide combination with rituximab and Anti-PD-1 Antibody | Experimental | All patients will receive the PPR regimen (a total of 4-6 cycles, 28 days for each cycle):
* pomalidomide: 4 mg, orally, once daily from Day 1 to Day 21.
* Rituximab: 375 mg/m², administered on Day 1.
* PD-1: 200 mg, administered on Days 1. Patients who achieved PR or CR after 6 cycles were treated with maintenance therapy at the investigator's discretion (1-2 years). Receives: Drug: Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of CR or PR.
Measured: 28days after the end of treatment
Secondary outcomes (5)
Complete Remission Rate（CRR）
The proportion of subjects who achieves a best overall response of CR.
Measured: 28days after the end of treatment
Disease-control Rate（DCR）
The proportion of subjects response of CR, PR, or SD
Measured: 28days after the end of treatment
Progression-Free Survival（PFS）
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Measured: Up to 2 years
overall survival（OS）
The overall survival time refers to the time from therapy to death due to any cause.
Measured: Up to 2 years
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: From date of first day of treatment until 30 day after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (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 Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang haiyan, Zhejiang Cancer Hospital
- Investigators
- Haiyan Yang, PhD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832228
- Sponsor's protocol ID
- PPR
- Status last verified
- Jun 2024
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-center Study of Pomalidomide Combination with Rituximab and Anti-PD-1 Antibody （PPR） in Third or Later Line Therapy of Diffuse Large B-cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT06832228
- Acronym / sponsor ID
- PPR
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 18 Feb 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.
This study aims to observe and explore the efficacy and safety of pomalidomide combination with rituximab and Anti-PD-1 Antibody in Third or Later Line Therapy of diffuse large B-cell lymphoma (DLBCL)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pomalidomide combination with rituximab and Anti-PD-1 Antibody | Experimental | Drug: Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR）All patients will receive the PPR regimen (a total of 4-6 cycles, 28 days for each cycle): * pomalidomide: 4 mg, orally, once daily from Day 1 to Day 21. * Rituximab: 375 mg/m², administered on Day 1. * PD-1: 200 mg, administered on Days 1. Patients who achieved PR or CR after 6 cycles were treated with maintenance therapy at the investigator's discretion (1-2 years). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients voluntarily joined the study, signed the informed consent, and had good compliance;
- Patients with 18 Years to 80 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2;
- Patients with histopathologically confirmed diffuse large B-cell lymphoma with evaluable lesions who did not achieve CR or relapsed after second-line therapy
- Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.
Key exclusion criteria (6 listed)
- Pathological subtypes: primary central nervous system DLBCL or primary mediastinal large B-cell lymphoma.
- Presence of severe or uncontrolled comorbid conditions including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer disease, or severe hemorrhagic disorders such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring transfusion or other medical interventions.
- A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Any active infection requiring systemic antimicrobial therapy within 14 days before starting study treatment, including, but not limited to, bacterial, fungal, and viral infections.
- Current participation in other clinical studies, or initiation of study drugs administration less than 4 weeks after completion of previous clinical study treatment.
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 |
|---|---|---|
| Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR）All patients will receive the PPR regimen (a total of 4-6 cycles, 28 days for each cycle): * pomalidomide: 4 mg, orally, once daily from Day 1 to Day 21. * Rituximab: 375 mg/m², administered on Day 1. * PD-1: 200 mg, administered on Days 1. | Drug | pomalidomide combination with rituximab and Anti-PD-1 Antibody |
Primary outcome
Overall Response Rate (ORR)
Time frame: 28days after the end of treatment
The proportion of subjects who achieves a best overall response of CR or PR.
5 secondary outcomes
Complete Remission Rate（CRR）
Time frame: 28days after the end of treatment
Disease-control Rate（DCR）
Time frame: 28days after the end of treatment
Progression-Free Survival（PFS）
Time frame: Up to 2 years
overall survival（OS）
Time frame: Up to 2 years
Adverse event rate
Time frame: From date of first day of treatment until 30 day after last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 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. This study is not recruiting at the moment.
Haiyan Yang, PhD principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR） in people with Diffuse Large B-cell Lymphoma (DLBCL), run by Zhejiang Cancer 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 4 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: status not confirmed, as of the sponsor's last update on 18 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haifeng Yu, MD (15157155533, yuhaifeng5533@dingtalk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: 28days after the end of treatment). 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 Feb 2025.