Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05949931
Other study ID # B2023-092
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date August 2023
Est. completion date December 2026

Study information

Verified date July 2023
Source Sun Yat-sen University
Contact Qingqing Cai, MD. PhD.
Phone 0086-20-87342823
Email caiqq@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 108
Est. completion date December 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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: ? maximum diameter of mediastinal mass/maximum diameter of thoracic cavity>0.33; ? 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Outcome

Type Measure Description Time frame Safety issue
Primary Complete response rate (CRR) Percentage of participants achieving complete response evaluated by the Independent Review Committee (IRC) at the end of all treatment courses From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Secondary Complete response rate (CRR) Percentage of participants achieving complete response evaluated by researchers From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Secondary Objective response rate(ORR) Percentage of participants achieve complete response and partial response From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
Secondary Progression-free Survival (PFS) From randomization to the first occurrence of disease progression as determined by the investigator, or death due to any cause, whichever occurs first Up to 5 years
Secondary Overall survival (OS) From randomization to the time of death from any cause. Up to 5 years
Secondary Safety indicators The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). Up to 5 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03233347 - Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma Phase 2
Active, not recruiting NCT03712202 - Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma Phase 2
Recruiting NCT05833984 - Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas Phase 1/Phase 2
Active, not recruiting NCT02758717 - Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma Phase 2
Active, not recruiting NCT01771107 - Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma Phase 1/Phase 2
Active, not recruiting NCT02166463 - Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma Phase 3
Completed NCT00654732 - Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma Phase 2
Active, not recruiting NCT04788043 - Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma Phase 2
Not yet recruiting NCT06465446 - A Study of IMM01 in Combiniation With Tiselizumab Versus Physician's Choice Chemotherapy in PD-(L)1-refractory Classical Hodgkin Lymphoma Phase 3
Recruiting NCT05955105 - A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies Phase 1/Phase 2
Completed NCT06235047 - Liposomal Doxorubicin-containing Front-line Treatment in Elderly Patients With HL (HL-MVD)
Recruiting NCT06164275 - Pembrolizumab Followed by Chemotherapy for the Treatment of Patients With Classical Hodgkin Lymphoma Phase 2
Active, not recruiting NCT05179603 - A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205] Phase 2
Active, not recruiting NCT03907488 - Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma Phase 3
Not yet recruiting NCT06377540 - MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma Phase 2
Active, not recruiting NCT03057795 - Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma Phase 2