Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
Location contact
Qingqing Cai
CONTACT
NCT Number: NCT05949931
This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
Qingqing Cai
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
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 researchers
Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Percentage of participants achieve complete response and partial response
Time frame: Up to 5 years
From randomization to the first occurrence of disease progression as determined by the investigator, or death due to any cause, whichever occurs first
Time frame: Up to 5 years
the time to progression, death, or noncomplete response and use of subsequent anticancer therapy.
Time frame: Up to 5 years
From randomization to the time of death from any cause.
Time frame: Up to 5 years
The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Contact information is provided by the study sponsor or research team.
Sun Yat-sen University
Other
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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