Double Expressor DLBCLPhase 1/2NCT07415980
Phase Ib/II Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients With Double-Expressor DLBCL
A Phase 1/2 study testing Polatuzumab Vedotin, Rituximab (R) and Chidamide in people with Double Expressor DLBCL, run by Sun Yat-sen University.
Trial summary
This is a single-arm, prospective, multicenter, open-label phase Ib/II study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab and chidamide in previously untreated elderly patients with MYC/BCL2 double-expressor diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Double Expressor DLBCL
- What is being tested?
- Polatuzumab Vedotin, Rituximab (R) and Chidamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2031
- Phase
- Phase 1/2
- 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
- Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
- Age ≥70 years, or age 60-69 years with frailty determined by comprehensive geriatric assessment (CGA).
- Pathologically confirmed diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) with MYC/BCL2 double expression, and no double-hit or triple-hit lymphoma.
- At least one measurable or evaluable lesion according to the Lugano 2014 criteria.
- No prior systemic therapy for DLBCL.
- Adequate organ and bone marrow function.
Who cannot join
- Other subtypes of DLBCL.
- Lymphoma involvement in the central nervous system or meninges.
- Active infections.
- History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
- Patients with mental disorders or those unable to provide informed consent
- Any other condition deemed by the investigator to be unsuitable for study enrollment.
- Known hypersensitivity to any investigational drug.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Phase Ib/II Clinical Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide for Untreated Elderly Diffuse Large B-cell Lymphoma Patients With Double Expression of MYC and BCL2
This is a single-arm, prospective, multicenter, open-label phase Ib/II study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab and chidamide in previously untreated elderly patients with MYC/BCL2 double-expressor diffuse large B-cell lymphoma.
- Conditions
- Double Expressor DLBCL
- Being tested
- Polatuzumab Vedotin, Rituximab (R), Chidamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polatuzumab VedotinDrug
1.8 mg/kg intravenously on Day 1 of each 21-day cycle.
Rituximab (R)Drug
375 mg/m² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle.
ChidamideDrug
20 mg, po, biw
| Study group | Role | What they receive |
|---|---|---|
| Polatuzumab Vedotin in Combination With Rituximab and Chidamide | Experimental | Participants receive polatuzumab vedotin in combination with rituximab and chidamide. Polatuzumab vedotin and rituximab are administered intravenously on Day 1 of each 21-day cycle according to the protocol-specified schedule. Chidamide is administered orally twice weekly, with an initial dose of 20 mg from Day 1 to Day 14, and at the RP2D dose level in the extension phase. Combination therapy is given for up to six cycles. Patients achieving complete response after combination therapy may receive chidamide monotherapy as maintenance treatment according to the study protocol. Receives: Drug: Polatuzumab Vedotin; Drug: Rituximab (R); Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT for Phase 1b
To identify the dose-limiting toxicity
Measured: The first cycle after administration (each cycle is 21 days)
RP2D for phase Ib
To identify the recommended phase 2 dose
Measured: The first cycle after administration (each cycle is 21 days)
Complete response rate (CRR) for Phase 2
The proportion of patients who achieve complete remission (CR).
Measured: Up to 6 cycles (every cycle is 21 days)
Secondary outcomes (4)
Overall response rate (ORR)
The proportion of patients who achieve complete response (CR) or partial response (PR).
Measured: Up to 6 cycles (every cycle is 21 days)
Duration of Response (DOR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 5 years
Progression-free survival (PFS)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 5 years
Overall survival (OS)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double Expressor DLBCLStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415980
- Sponsor's protocol ID
- B2025-693
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase Ib/II Clinical Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide for Untreated Elderly Diffuse Large B-cell Lymphoma Patients With Double Expression of MYC and BCL2
- ClinicalTrials.gov ID
- NCT07415980
- Acronym / sponsor ID
- B2025-693
- Conditions
- Double Expressor DLBCL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 17 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.
This is a single-arm, prospective, multicenter, open-label phase Ib/II study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab and chidamide in previously untreated elderly patients with MYC/BCL2 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 |
|---|---|---|
| Polatuzumab Vedotin in Combination With Rituximab and Chidamide | Experimental | Drug: Polatuzumab Vedotin, Drug: Rituximab (R), Drug: ChidamideParticipants receive polatuzumab vedotin in combination with rituximab and chidamide. Polatuzumab vedotin and rituximab are administered intravenously on Day 1 of each 21-day cycle according to the protocol-specified schedule. Chidamide is administered orally twice weekly, with an initial dose of 20 mg from Day 1 to Day 14, and at the RP2D dose level in the extension phase. Combination therapy is given for up to six cycles. Patients achieving complete response after combination therapy may receive chidamide monotherapy as maintenance treatment according to the study protocol. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
- Age ≥70 years, or age 60-69 years with frailty determined by comprehensive geriatric assessment (CGA).
- Pathologically confirmed diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) with MYC/BCL2 double expression, and no double-hit or triple-hit lymphoma.
- At least one measurable or evaluable lesion according to the Lugano 2014 criteria.
- No prior systemic therapy for DLBCL.
Key exclusion criteria (7 listed)
- Other subtypes of DLBCL.
- Lymphoma involvement in the central nervous system or meninges.
- Active infections.
- History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
- Patients with mental disorders or those unable to provide informed consent
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 |
|---|---|---|
| Polatuzumab Vedotin1.8 mg/kg intravenously on Day 1 of each 21-day cycle. | Drug | Polatuzumab Vedotin in Combination With Rituximab and Chidamide |
| Rituximab (R)375 mg/m² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle. | Drug | Polatuzumab Vedotin in Combination With Rituximab and Chidamide |
| Chidamide20 mg, po, biw | Drug | Polatuzumab Vedotin in Combination With Rituximab and Chidamide |
Primary outcome
DLT for Phase 1b
Time frame: The first cycle after administration (each cycle is 21 days)
To identify the dose-limiting toxicity
RP2D for phase Ib
Time frame: The first cycle after administration (each cycle is 21 days)
To identify the recommended phase 2 dose
Complete response rate (CRR) for Phase 2
Time frame: Up to 6 cycles (every cycle is 21 days)
The proportion of patients who achieve complete remission (CR).
4 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 6 cycles (every cycle is 21 days)
Duration of Response (DOR)
Time frame: Up to 5 years
Progression-free survival (PFS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 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 17 Feb 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Polatuzumab Vedotin, Rituximab (R) and Chidamide in people with Double Expressor DLBCL, 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Feb 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Qingqing Cai, MD. PhD. (+8602087342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT for Phase 1b (time frame: The first cycle after administration (each cycle is 21 days)). The study lists 3 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 17 Feb 2026.