Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT07397832
CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL
A Phase 2 study testing Chidamide, Rituximab and Polatuzumab Vedotin in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- Chidamide, Rituximab and Polatuzumab Vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2026to 30 Dec 2028
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥70 years, or patients aged 60-69 years with an ECOG performance status score of 2-4. Both males and females are eligible.
- No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy directed at the lymphoma (excluding palliative radiotherapy for symptom relief), or surgical therapy (excluding diagnostic biopsy or surgery not targeting the lymphoma).
- Histopathological confirmation meeting all of the following conditions:
- Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20 positivity; concurrent positive expression of C-MYC and Bcl-2 (double-expressor phenotype).
- At least one measurable lesion positive on ¹⁸F-FDG PET-CT scan according to the Lugano 2014 criteria for Hodgkin and non-Hodgkin lymphoma.
- Laboratory tests at screening must meet the following criteria, unless the investigator attributes abnormalities to lymphoma (no corrective or supportive therapy for these parameters within 2 weeks prior to assessment):
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- Hematology: Hb ≥90 g/L, ANC ≥1.5 × 10⁹/L, PLT ≥90 × 10⁹/L.
- Biochemistry: Cr ≤1.5 ×ULN; TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (for patients with liver involvement: ≤5 × ULN).
- Life expectancy of at least 6 months, as judged by the investigator.
- Ability to understand and voluntarily provide written informed consent.
Who cannot join
- History of or concurrent other active malignancies.
- Prior treatment with Chidamide and/or R-CHOP. Contraindication to any component of CHOP, including prior anthracycline therapy. History of severe hypersensitivity or anaphylaxis to humanized or murine monoclonal antibodies, or known sensitivity/allergy to murine products.
- Current diagnosis of any of the following: Follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma); Primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; Central nervous system (CNS) lymphoma (primary or secondary); Primary effusion DLBCL; Primary cutaneous DLBCL, leg type.
- History of myocardial infarction, unstable angina, or other clinically significant cardiac disease within 12 months prior to signing informed consent; or prior coronary angioplasty/stenting within 12 months.
- Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage.
- Pregnant or lactating women.
- Participation in any other clinical trial within 6 months prior to signing informed consent.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this 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
Tianjin Medical University Cancer Insititute & Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: CRP Regimen (Chidamide, Rituximab and Polatuzumab Vedotin) in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL: Single-Arm, Open-Label, Multicenter Phase II Trial
A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma
Read the detailed description
This is a single-arm, open-label, multicenter Phase II trial to evaluate the feasibility, efficacy, and safety of the CRP regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in treating elderly patients with previously untreated double-expressor diffuse large B-cell lymphoma.
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Being tested
- Chidamide, Rituximab, Polatuzumab Vedotin, Chidamide Maintenance
- Keywords
- Diffuse Large B-Cell Lymphoma
- 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.
ChidamideDrug
Also called HDACi
Chidamide: patients followed a step-dose escalation regimen (10mg BIW,15mg BIW, 20mg BIW). 21 days as a treatment cycle. The maximum number of treatment cycles is six.
RituximabDrug
Also called R
Day 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six.
Polatuzumab VedotinDrug
Also called Pola
Day 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six.
Chidamide MaintenanceDrug
Also called HDACi Maintenance
For patients assessed as being in PR or CR status after completion of combination therapy, maintenance therapy with chidamide is administered for one year at a dosage of 20 mg, BIW. Drug adjustments may be made based on the patient's tolerance, with reference to the drug prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten | Experimental | Each subject will be given combination therapy of Chidamide, Rituximab and Polatuzumab Vedotin.The maximum number of treatment cycles is six. Receives: Drug: Chidamide; Drug: Rituximab; Drug: Polatuzumab Vedotin; Drug: Chidamide Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CRR)
To assess the Complete Response Rate (CR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin).
Measured: up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days
Secondary outcomes (7)
Overall Response Rate (ORR)
To assess the Overall Response Rate (ORR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin).
Measured: up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days
Progression-free survival (PFS)
The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first."
Measured: up to 2 years
Event free survival(EFS)
The duration from the time of study enrollment until the occurrence of disease progression, relapse after complete response (CR), death from any cause, or the initiation of new treatment for residual lesions after completion of combination therapy (including switched therapy for lesions during the trial), whichever occurs first.
Measured: up to 2 years
Overall Survival(OS)
The time from subject enrollment to Death caused by any reason. for patients lost to follow-up, the time of the last follow-up; for patients still alive at the end of study, the date of the end of follow-up.
Measured: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.The frequency and severity of adverse events were evaluated based on changes in various vital sign indicators and laboratory tests.
Measured: up to 2 years
Quality of Life Assessment - EORTC QLQ-C30 Score
Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The score changes in overall quality of life, functional scales, and symptom scales will be analyzed in relation to clinical outcomes.
Measured: up to 2 years
Quality of Life Assessment - FACT-Lym Score
Disease-specific quality of life will be assessed using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire (Version 4). The score changes will be analyzed in relation to clinical outcomes.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start3 Feb 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Dec 2028 (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 Tianjin Medical University Cancer Institute and 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huilai Zhang, Study director, Tianjin Medical University Cancer Insititute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397832
- Sponsor's protocol ID
- CRP-DLBCL01
- Status last verified
- Jul 2026
- First submitted
- 4 Jan 2026
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRP Regimen (Chidamide, Rituximab and Polatuzumab Vedotin) in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL: Single-Arm, Open-Label, Multicenter Phase II Trial
- ClinicalTrials.gov ID
- NCT07397832
- Acronym / sponsor ID
- CRP-DLBCL01
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Keywords
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 Feb 2026 (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.
A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma
Detailed description
This is a single-arm, open-label, multicenter Phase II trial to evaluate the feasibility, efficacy, and safety of the CRP regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in treating elderly patients with previously untreated double-expressor diffuse large B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten | Experimental | Drug: Chidamide, Drug: Rituximab, Drug: Polatuzumab Vedotin, Drug: Chidamide MaintenanceEach subject will be given combination therapy of Chidamide, Rituximab and Polatuzumab Vedotin.The maximum number of treatment cycles is six. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged ≥70 years, or patients aged 60-69 years with an ECOG performance status score of 2-4. Both males and females are eligible.
- No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy directed at the lymphoma (excluding palliative radiotherapy for symptom relief), or surgical therapy (excluding diagnostic biopsy or surgery not targeting the lymphoma).
- Histopathological confirmation meeting all of the following conditions:
- Laboratory tests at screening must meet the following criteria, unless the investigator attributes abnormalities to lymphoma (no corrective or supportive therapy for these parameters within 2 weeks prior to assessment):
- Life expectancy of at least 6 months, as judged by the investigator.
Key exclusion criteria (8 listed)
- History of or concurrent other active malignancies.
- Prior treatment with Chidamide and/or R-CHOP. Contraindication to any component of CHOP, including prior anthracycline therapy. History of severe hypersensitivity or anaphylaxis to humanized or murine monoclonal antibodies, or known sensitivity/allergy to murine products.
- Current diagnosis of any of the following: Follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma); Primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; Central nervous system (CNS) lymphoma (primary or secondary); Primary effusion DLBCL; Primary cutaneous DLBCL, leg type.
- History of myocardial infarction, unstable angina, or other clinically significant cardiac disease within 12 months prior to signing informed consent; or prior coronary angioplasty/stenting within 12 months.
- Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage.
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 |
|---|---|---|
| ChidamideAlso: HDACiChidamide: patients followed a step-dose escalation regimen (10mg BIW,15mg BIW, 20mg BIW). 21 days as a treatment cycle. The maximum number of treatment cycles is six. | Drug | Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten |
| RituximabAlso: RDay 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six. | Drug | Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten |
| Polatuzumab VedotinAlso: PolaDay 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six. | Drug | Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten |
| Chidamide MaintenanceAlso: HDACi MaintenanceFor patients assessed as being in PR or CR status after completion of combination therapy, maintenance therapy with chidamide is administered for one year at a dosage of 20 mg, BIW. Drug adjustments may be made based on the patient's tolerance, with reference to the drug prescribing information. | Drug | Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten |
Primary outcome
Complete Response Rate (CRR)
Time frame: up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days
To assess the Complete Response Rate (CR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin).
7 secondary outcomes
Overall Response Rate (ORR)
Time frame: up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days
Progression-free survival (PFS)
Time frame: up to 2 years
Event free survival(EFS)
Time frame: up to 2 years
Overall Survival(OS)
Time frame: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 2 years
Quality of Life Assessment - EORTC QLQ-C30 Score
Time frame: up to 2 years
Quality of Life Assessment - FACT-Lym Score
Time frame: up to 2 years
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 29 Jul 2026.
- 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.
Huilai Zhang study director
Tianjin Medical University Cancer Insititute & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide, Rituximab and Polatuzumab Vedotin in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Tianjin Medical University Cancer Institute and 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 10 inclusion and 8 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 29 Jul 2026. 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 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?
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 Huilai Zhang (+86-18622221228, huilaizhangtz@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: up to the end of CRP Regimen treatment, no more than 6 cycles, 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 29 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.