Diffuse Large B Cell Lymphoma (DLBCL)Phase 1/2NCT07398638
Lisatoclax Plus R-CHOP or Pola-R-CHP in Untreated DLBCL: A Phase Ib/II Study
A Phase 1/2 study testing R-CHOP, POLA-R-CHP and Lisaftoclax in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, multicenter, open-label Phase Ib/II clinical study designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of lisatoclax in combination with R-CHOP or Pola-R-CHP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- R-CHOP, POLA-R-CHP and Lisaftoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 28 Feb 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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.
- 2. Diagnosed with DLBCL according to 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center. For the dose-expansion phase, BCL-2 positivity (≥50% by IHC) is required.
- 3. Age 18-70 years.
- 4. No prior systemic anti-lymphoma therapy.
- 5. Adequate organ and bone marrow function.
- 6. At least one measurable or evaluable disease site according to the Lugano 2014 lymphoma efficacy evaluation criteria.
- 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Who cannot join
- 1. Lymphoma involvement in the central nervous system or meninges.
- 2. Active infections.
- 3. Uncontrolled clinical cardiac symptoms or diseases.
- 4. Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
- 5. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
- 6. History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
- 7. Patients with mental disorders or those unable to provide informed consent
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Qingqing Cai, M.D. Ph.D, 0086-20-87342823, caiqq@sysucc.org.cn
About this study
Official title: A Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Lisatoclax in Combination With R-CHOP or Pola-R-CHP in Patients With Previously Untreated DLBCL
This is a prospective, multicenter, open-label Phase Ib/II clinical study designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of lisatoclax in combination with R-CHOP or Pola-R-CHP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Being tested
- R-CHOP, POLA-R-CHP, Lisaftoclax
- 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.
R-CHOPDrug
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
POLA-R-CHPDrug
Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone
LisaftoclaxDrug
Lisaftoclax (400 mg or 600 mg) is added from the second cycle of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Lisatoclax Combined with R-CHOP or Pola-R-CHP | Experimental | In Cohort 1, patients will receive standard-dose R-CHOP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with R-CHOP at the RP2D dose level for an extension study.
In Cohort 2, patients will receive standard-dose Pola-R-CHP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with Pola-R-CHP at the RP2D dose level for an extension study. Receives: Drug: R-CHOP; Drug: POLA-R-CHP; Drug: Lisaftoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) for Phase 1b
To identify the DLT
Measured: The first cycle (each cycle is 21 days) after lisaftoclax administration.
Complete response rate (CRR) for Phase 2
The proportion of patients who achieve complete response (CR)
Measured: Up to 8 cycles (each 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 8 cycles (each 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 posted10 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2031 (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 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
- 122 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
- NCT07398638
- Sponsor's protocol ID
- B2025-809
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 10 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Lisatoclax in Combination With R-CHOP or Pola-R-CHP in Patients With Previously Untreated DLBCL
- ClinicalTrials.gov ID
- NCT07398638
- Acronym / sponsor ID
- B2025-809
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 10 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 prospective, multicenter, open-label Phase Ib/II clinical study designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of lisatoclax in combination with R-CHOP or Pola-R-CHP in patients with previously untreated 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 |
|---|---|---|
| Lisatoclax Combined with R-CHOP or Pola-R-CHP | Experimental | Drug: R-CHOP, Drug: POLA-R-CHP, Drug: LisaftoclaxIn Cohort 1, patients will receive standard-dose R-CHOP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with R-CHOP at the RP2D dose level for an extension study. In Cohort 2, patients will receive standard-dose Pola-R-CHP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with Pola-R-CHP at the RP2D dose level for an extension study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. 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.
- 2. Diagnosed with DLBCL according to 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center. For the dose-expansion phase, BCL-2 positivity (≥50% by IHC) is required.
- 3. Age 18-70 years.
- 4. No prior systemic anti-lymphoma therapy.
- 5. Adequate organ and bone marrow function.
Key exclusion criteria (7 listed)
- 1. Lymphoma involvement in the central nervous system or meninges.
- 2. Active infections.
- 3. Uncontrolled clinical cardiac symptoms or diseases.
- 4. Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
- 5. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
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 |
|---|---|---|
| R-CHOPRituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone | Drug | Lisatoclax Combined with R-CHOP or Pola-R-CHP |
| POLA-R-CHPPolatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone | Drug | Lisatoclax Combined with R-CHOP or Pola-R-CHP |
| LisaftoclaxLisaftoclax (400 mg or 600 mg) is added from the second cycle of chemotherapy. | Drug | Lisatoclax Combined with R-CHOP or Pola-R-CHP |
Primary outcome
Dose-limiting toxicity (DLT) for Phase 1b
Time frame: The first cycle (each cycle is 21 days) after lisaftoclax administration.
To identify the DLT
Complete response rate (CRR) for Phase 2
Time frame: Up to 8 cycles (each cycle is 21 days)
The proportion of patients who achieve complete response (CR)
4 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 8 cycles (each 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 10 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing R-CHOP, POLA-R-CHP and Lisaftoclax in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Sun Yat-sen 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 7 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 10 Feb 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 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. (02087342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) for Phase 1b (time frame: The first cycle (each cycle is 21 days) after lisaftoclax administration.). 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 10 Feb 2026.