drugset / Trial / NCT05243693

Brentuximab Vedotin Plus DHAP in Relapsed or Refractory Hodgkin's Lymphoma

NCT05243693

Phase 2 Unknown 30 enrolled National Cancer Center, Korea
NaSingle-groupOpen-labelTreatment

Summary

\< STUDY DESIGN \> This study is a multi-center phase II trial in patients with relapsed or refractory Hodgkin's lymphoma after first-line treatment. \< Treatment Schedule \> 1. Induction phase * Patients who sign the informed consent form (ICF) receive BV-DHAP induction therapy within 21 days. * Tumor response is evaluated following 2 cycles of induction therapy. As a result of tumor response evaluation, PD (progressive disease) means a withdrawal from the study; and CR (complete response), PR (partial response), or SD (stable disease) requires peripheral blood stem cell collection (PBSCC) followed by additional one cycle of induction therapy. * Following a total of 3 cycles of induction therapy, tumor response is evaluated again. If the result turns out to be CR or PR, treatment goes on to autologous stem cell transplant (ASCT). SD or PD means a withdrawal from the study. 2. Consolidation phase - ASCT is performed in accordance with a protocol based on the relevant site's policy.

Timeline

Start
2022-03
Primary completion
2024-02-28
Completion
2026-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Brentuximab Vedotin Monoclonal antibody 1.8 mg/kg Intravenous