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RECRUITING
NCT04378647
PHASE2

BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant

Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2020-06-01

Completion Date

2026-08-30

Last Updated

2024-02-26

Healthy Volunteers

No

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)

Locations (19)

Institut Català D'Oncologia - Hospital Germans Trias I Pujol

Barcelona, Barceolna, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Complexo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

Institut Català D'Oncologia - Hospital Duran I Reynals

Barcelona, Spain

Institut Català D'Oncologia

Barcelona, Spain

Hospital Universitario de Cruces

Bilbao, Spain

Hospital Universitario Virgen de Las Nieves

Granada, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Ramón Y Cajal

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital General Universitario J.M. Morales Meseguer

Murcia, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Virgen Del Rocío

Seville, Spain

Hospital Universitario Y Politécnico La Fe

Valencia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain