Classic Hodgkin LymphomaPhase 2NCT05949931
Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma
A Phase 2 study testing Concurrent penpulimab and AVD and Sequential penpulimab and AVD in people with Classic Hodgkin Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classic Hodgkin Lymphoma
- What is being tested?
- Concurrent penpulimab and AVD and Sequential penpulimab and AVD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months;
- classic Hodgkin lymphoma (cHL) confirmed by histopathology;
- The subject must be advanced patient, specifically defined as Ann Arbor stage III-IV or IIB with any of the following high-risk factors: ① maximum diameter of mediastinal mass/maximum diameter of thoracic cavity>0.33; ② There are large masses with a diameter of>10cm;
- Have not received systemic anti classic Hodgkin lymphoma treatment;
- Measurable disease ;
- Adequate main organs function
- Female subjects of childbearing age should agree to use contraceptives (such as Intrauterine device, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine Pregnancy test was negative within 7 days before the study was included, and must be non-lactating subjects; Male participants should agree to use contraception during the study period and within 6 months after the end of the study period.
Who cannot join
- Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;
- Classic Hodgkin lymphoma involves the central nervous system;
- Subjects who have or are suspected to have active autoimmune diseases within the past 2 years, or have previously suffered from autoimmune diseases and are currently at high risk of recurrence and require systemic treatment；
- Subjects who need to use glucocorticoid (>10mg/day prednisone Equivalent dose) or other immunosuppressive drugs for systemic treatment within 14 days before the first administration.
- Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration;
- Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
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- Known to have active pulmonary tuberculosis;
- Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases;
- Subjects with a known history of interstitial pneumonia, a history of non-infectious pneumonia, or highly suspected cases of interstitial pneumonia;
- Patients with evidence of bleeding constitution or medical history; Within 4 weeks before the first medication, any ≥ CTC AE level 3 bleeding events (such as digestive tract bleeding, perforation, etc.) occur;
- Concomitant diseases and medical history:
- Has experienced or currently suffers from other malignant tumors within 3 years.
- Multiple factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction);
- Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;
- Subjects with any severe and/or uncontrollable disease.
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
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510060
Qingqing Cai
About this study
Official title: A Randomized, Open, Multicenter Phase II Clinical Trial of Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma (PENAHL Study)
This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
- Conditions
- Classic Hodgkin Lymphoma
- Being tested
- Concurrent penpulimab and AVD, Sequential penpulimab and AVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent penpulimab and AVDDrug
Participants will receive Penpulimab and AVD injection at the same time for a total of 6 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.
Sequential penpulimab and AVDDrug
Participants will receive penpulimab for 3 cycles; follewed by 6 cycles of AVD; finally, penpulimab for 3 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent penpulimab and AVD | Experimental | Participants will receive Penpulimab and AVD injection at the same time for a total of 6 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle. Receives: Drug: Concurrent penpulimab and AVD |
| Sequential penpulimab and AVD | Experimental | Participants will receive penpulimab for 3 cycles; follewed by 6 cycles of AVD; finally, penpulimab for 3 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle. Receives: Drug: Sequential penpulimab and AVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate （CRR）
Percentage of participants achieving complete response evaluated by the Independent Review Committee (IRC) at the end of all treatment courses
Measured: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Secondary outcomes (6)
Complete response rate （CRR）
Percentage of participants achieving complete response evaluated by researchers
Measured: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Objective response rate（ORR）
Percentage of participants achieve complete response and partial response
Measured: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Progression-free Survival (PFS)
From randomization to the first occurrence of disease progression as determined by the investigator, or death due to any cause, whichever occurs first
Measured: Up to 5 years
Modified progression-free survival (mPFS)
the time to progression, death, or noncomplete response and use of subsequent anticancer therapy.
Measured: Up to 5 years
Overall survival (OS)
From randomization to the time of death from any cause.
Measured: Up to 5 years
Safety indicators
The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
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 posted18 Jul 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Hodgkin LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 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
- NCT05949931
- Sponsor's protocol ID
- B2023-092
- Status last verified
- Apr 2026
- First submitted
- 10 Jul 2023
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Multicenter Phase II Clinical Trial of Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma (PENAHL Study)
- ClinicalTrials.gov ID
- NCT05949931
- Acronym / sponsor ID
- B2023-092
- Conditions
- Classic Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jul 2023 (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 is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent penpulimab and AVD | Experimental | Drug: Concurrent penpulimab and AVDParticipants will receive Penpulimab and AVD injection at the same time for a total of 6 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle. |
| Sequential penpulimab and AVD | Experimental | Drug: Sequential penpulimab and AVDParticipants will receive penpulimab for 3 cycles; follewed by 6 cycles of AVD; finally, penpulimab for 3 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: ≥18 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months;
- classic Hodgkin lymphoma (cHL) confirmed by histopathology;
- The subject must be advanced patient, specifically defined as Ann Arbor stage III-IV or IIB with any of the following high-risk factors: ① maximum diameter of mediastinal mass/maximum diameter of thoracic cavity>0.33; ② There are large masses with a diameter of>10cm;
- Have not received systemic anti classic Hodgkin lymphoma treatment;
- Measurable disease ;
Key exclusion criteria (15 listed)
- Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;
- Classic Hodgkin lymphoma involves the central nervous system;
- Subjects who have or are suspected to have active autoimmune diseases within the past 2 years, or have previously suffered from autoimmune diseases and are currently at high risk of recurrence and require systemic treatment；
- Subjects who need to use glucocorticoid (>10mg/day prednisone Equivalent dose) or other immunosuppressive drugs for systemic treatment within 14 days before the first administration.
- Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration;
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 |
|---|---|---|
| Concurrent penpulimab and AVDParticipants will receive Penpulimab and AVD injection at the same time for a total of 6 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle. | Drug | Concurrent penpulimab and AVD |
| Sequential penpulimab and AVDParticipants will receive penpulimab for 3 cycles; follewed by 6 cycles of AVD; finally, penpulimab for 3 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle. | Drug | Sequential penpulimab and AVD |
Primary outcome
Complete response rate （CRR）
Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Percentage of participants achieving complete response evaluated by the Independent Review Committee (IRC) at the end of all treatment courses
6 secondary outcomes
Complete response rate （CRR）
Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Objective response rate（ORR）
Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Progression-free Survival (PFS)
Time frame: Up to 5 years
Modified progression-free survival (mPFS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Safety indicators
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 1 May 2026.
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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 2 study testing Concurrent penpulimab and AVD and Sequential penpulimab and AVD in people with Classic Hodgkin Lymphoma, 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 15 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 1 May 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 Qingqing Cai, MD. PhD. (0086-20-87342823, caiqq@sysucc.org.cn), 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: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)). 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 1 May 2026.