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New treatment option for Classic Hodgkin Lymphoma
Official title Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT05949931
What this study is testing
What is Concurrent penpulimab and AVD?
Concurrent penpulimab and AVD is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for classic hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Have not received systemic anti classic Hodgkin lymphoma treatment;
- Measurable disease ;
You likely can't join if
- Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;
- Classic Hodgkin lymphoma involves the central nervous system;
- people who have or are suspected to have active autoimmune diseases within the past 2 years, or have previously suffered from autoimmune diseases and...
- people who need to use glucocorticoid (\>10mg/day prednisone Equivalent dose) or other immunosuppressive drugs for systemic treatment within 14 days...
- 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;
See the full eligibility 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...
- Have not received systemic anti classic Hodgkin lymphoma treatment;
- Measurable disease ;
- Adequate main organs function
- Female people 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...
- Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;
- Classic Hodgkin lymphoma involves the central nervous system;
- people 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...
- people 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;
- people 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;
- people with any severe and/or uncontrollable disease.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.