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Brentuximab Vedotin and Nivolumab for the Treatment of Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

StatusRecruiting
PhasePhase 2
Started2021-11-12
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 2, 2026 → Oct 2, 2027
See other at-risk trials from City of Hope Medical Center

Amendment history

2026-09-23
Primary completion pushed: 2026-10-02 → 2027-10-02
Completion pushed: 2026-10-02 → 2027-10-02
2025-09-19
Study Identification, Study Status, Oversight, Contacts/Locations v9
Study sitescontacts updated at 1 of 5 sites
Study titlerevised
Brentuximab Vedotin and Nivolumab for the Treatment of Patients withWith Relapsed/refractoryRefractory Classical Hodgkin Lymphoma
2024-09-17
Study Identification, Study Status, Oversight, Contacts/Locations v8
Primary completion date2024-10-02→2026-10-02
Completion date2024-10-02→2026-10-02
Study sitescontacts updated at 1 of 5 sites
Study titlerevised
Brentuximab Vedotin and Nivolumab for the Treatment of Patients Withwith Relapsed/Refractoryrefractory Classical Hodgkin Lymphoma
2023-09-14
Study Identification, Study Status, Study Description, Conditions, Eligibility, Contacts/Locations v7
Study sites1→5
Eligibility criteria-1 characters
[...] ith hematopathology review at the participating institution FirstRelapsed relapse,or definedrefractory as: Nodisease after no more than 1 line of prior therapy (not counting radiotherapy). NoHowever, a maximum of 5 patients with primary refractory disease (i.emay be enrolled in this study. patientsNote: cannot have relapsed within 90 days of the end of frontline therapy) Patients who received BV or an anti-PD-1/PD-L1 agent as part [...]
Study description+31 characters
[...] by 24-month progression-free survival (PFS) in participants (with 1st relapse ofrelapsed/refractory classical Hodgkin lymphoma (RcHL) after frontline therapy) who achieved early complete metabolic response (CMR) (CMR [...]
Study title+11 characters
Brentuximab Vedotin and Nivolumab for the Treatment of Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
2023-02-19
Study Status v6
Primary completion date2023-10-15→2024-10-02
Completion date2023-10-15→2024-10-02
Show 5 earlier versions
2022-02-16
Study Status v5
Start dateestimated 2021-12-15→confirmed 2021-11-12
2021-11-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start date2021-10-15→2021-12-15
Study sitesdetails revised at 1 of 1 site
2021-08-10
Study Status v3
Primary completion date2022-10-15→2023-10-15
Completion date2022-10-15→2023-10-15
Start date2021-05-15→2021-10-15
2021-02-09
Study Status v2
Start date2021-01-15→2021-05-15
2020-12-15
Study Status v1
Start date2020-10-15→2021-01-15
2020-09-17
Original filing
This phase II trial investigates how well brentuximab vedotin and nivolumab work in treating patients with classical Hodgkin lymphoma that has come back after initial treatment (relapsed) or has not responded to initial treatment (refractory). Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Nivolumab is an antibody that enhances the immune system to better fight Hodgkin lymphoma cells. Giving brentuximab vedotin and nivolumab may be able to defer stem cell transplant treatment and spare the considerable cost and toxicity on transplantation.
Trial Details
NCT Number NCT04561206
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Relapsed Classic Hodgkin Lymphoma
Enrollment 31 participants
Start Date 2021-11-12
Primary Completion 2027-10-02 (estimated)
Study Completion 2027-10-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-22