Recruiting NCT05949931
Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Concurrent penpulimab and AVD, Sequential penpulimab and AVD.
- Who it may be relevant to
- Registry conditions: Classic Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
Interventions
- Drug Concurrent penpulimab and AVD
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. - Drug Sequential penpulimab and AVD
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.
Primary outcome measures
- Complete response rate （CRR） [Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Guangzhou
Identifiers
NCT: NCT05949931 · B2023-092