Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma
Recruiting
Phase 2Interventional Study
Classic Hodgkin Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
108 (estimated)
Sponsor
Sun Yat-sen University · Other
Who this trial is looking for
This trial is looking for adults who have been diagnosed with advanced classic Hodgkin lymphoma and have not yet had treatment. Participants will receive a combination of Penpulimab and standard chemotherapy.
Are You a Good Fit for This Trial?
Rules you outActive autoimmune diseasesLung problemsActive tuberculosisHIV infection
You may be able to join if
I am at least 18 years old.
I have classic Hodgkin lymphoma confirmed by a doctor.
I have advanced Hodgkin lymphoma.
I have not received treatment for Hodgkin lymphoma before.
I have measurable disease.
I have good function of my main organs.
If I am a woman of childbearing age, I will use contraceptives.
If I am a man, I will use contraceptives.
You may not be able to join if
I have nodular lymphocyte predominant Hodgkin lymphoma.
I have Hodgkin lymphoma that involves my central nervous system.
I have had active autoimmune diseases in the last 2 years.
I need glucocorticoids or immunosuppressive drugs before starting this trial.
I have received live vaccines in the last 4 weeks.
I have a history of certain severe lung issues.
I have a history of active pulmonary tuberculosis.
I have a known HIV infection or other severe immune system issues.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age: ≥18 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months;
2. classic Hodgkin lymphoma (cHL) confirmed by histopathology;
3. The subject must be advanced patient, specifically defined as Ann Arbor stag…
Inclusion Criteria:
1. Age: ≥18 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months;
2. classic Hodgkin lymphoma (cHL) confirmed by histopathology;
3. 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;
4. Have not received systemic anti classic Hodgkin lymphoma treatment;
5. Measurable disease ;
6. Adequate main organs function
7. 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.
Exclusion Criteria:
1. Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;
2. Classic Hodgkin lymphoma involves the central nervous system;
3. 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;
4. 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.
5. Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration;
6. Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
7. Known to have active pulmonary tuberculosis;
8. Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases;
9. Subjects with a known history of interstitial pneumonia, a history of non-infectious pneumonia, or highly suspected cases of interstitial pneumonia;
10. 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;
11. Concomitant diseases and medical history:
1. Has experienced or currently suffers from other malignant tumors within 3 years.
2. Multiple factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction);
3. Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;
4. Subjects with any severe and/or uncontrollable disease.
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