RecruitingPhase 2NCT05949931

Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma

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)


Sponsor

Sun Yat-sen University

Enrollment

108 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called pianzumab combined with a standard chemotherapy regimen (AVD) as a first treatment for newly diagnosed advanced classic Hodgkin lymphoma. Researchers want to see if adding pianzumab improves outcomes compared to standard therapy. **You may be eligible if...** - You are 18 to 70 years old - You have been newly diagnosed with classic Hodgkin lymphoma at an advanced stage (Stage III-IV, or Stage IIB with high-risk features) - You have not yet received any treatment for Hodgkin lymphoma - Your overall health is good enough to tolerate treatment - You have adequate heart, liver, kidney, and blood cell function **You may NOT be eligible if...** - You have nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma - Your lymphoma has spread to the brain or spinal fluid - You have an active autoimmune disease - You are HIV positive or have a history of immune deficiency - You have active tuberculosis or interstitial lung disease - You have had another cancer in the past 3 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGConcurrent 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.

DRUGSequential 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.


Locations(1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT05949931


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