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Trial Title:
Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma
NCT ID:
NCT05949931
Condition:
Classic Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Concurrent penpulimab and AVD
Description:
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.
Arm group label:
Concurrent penpulimab and AVD
Intervention type:
Drug
Intervention name:
Sequential penpulimab and AVD
Description:
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.
Arm group label:
Sequential penpulimab and AVD
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18-70 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingqing Cai
Start date:
October 1, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05949931
