RecruitingPhase 2NCT05243693

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

Brentuximab Vedotin Plus Cisplatin, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Hodgkin's Lymphoma Who Are Eligible for Transplant


Sponsor

National Cancer Center, Korea

Enrollment

30 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding brentuximab vedotin — a targeted antibody drug that attacks a protein called CD30 on Hodgkin's lymphoma cells — to the standard chemotherapy regimen DHAP improves treatment response in patients whose Hodgkin's lymphoma has relapsed or not responded to first-line therapy. **You may be eligible if...** - You are 19 to 70 years old with a confirmed diagnosis of classical Hodgkin's lymphoma - Your lymphoma has come back or did not respond to first-line treatment - You have not received more than 1 prior line of treatment - Your CD30 protein is positive on biopsy - Your organ function (liver, kidneys, lungs, blood counts) meets the required thresholds **You may NOT be eligible if...** - You have non-Hodgkin's lymphoma - You have received 2 or more prior lines of treatment - You have known brain or spinal cord involvement from the lymphoma - 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

DRUGBrentuximab vedotin

3 cycles of Brentuximab vedotin and DHAP


Locations(1)

Hyeon-Seok Eom

Goyang-si, Gyeonggi-do, South Korea

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NCT05243693