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

NCT05243693 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-02-17

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory Classical Hodgkin Lymphoma

Interventions

DRUG

Brentuximab vedotin

3 cycles of Brentuximab vedotin and DHAP

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Hyeon-Seok Eom, MD, PhD · National Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05243693 on ClinicalTrials.gov