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BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant

NCT04378647 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-02-26

No results posted yet for this study

Summary

A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy

Conditions

  • Hodgkin Lymphoma, Adult

Interventions

DRUG

Induction with Brentuximab vedotin (BV)

3 cycles ESHAP plus antibody-drug conjugate brentuximab vedotin (BV) at a dose of 1.8 mg/kg IV

DRUG

Induction without Brentuximab Vedotin

3 cycles of ESHAP as a standard of care therapy for those patients with primary refractory cHL and those patients relapsing after first-line therapy

DRUG

Consolidation with Brentuximab Vedotin

Up to 13 or 16 cycles of antibody-drug conjugate brentuximab vedotin (BV) at doses of 1.8 mg/kg iv every 21 days)

Sponsors & Collaborators

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    lead OTHER

Principal Investigators

  • Anna Sureda, PhD · Institut Català d'Oncologia, Hospital Duran i Reynals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2026-08-30
Completion
2026-08-30

Countries

  • Spain

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 NCT04378647 on ClinicalTrials.gov