RecruitingPhase 2NCT04378647

BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant

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


Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Enrollment

150 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests brentuximab vedotin (an antibody-drug combination that targets a protein called CD30 on cancer cells) as second-line therapy for people with Hodgkin's lymphoma that has come back after initial treatment, before they receive a stem cell transplant. The goal is to see whether brentuximab can help more patients respond well enough to proceed to transplant. **You may be eligible if...** - You are between 18 and 65 years old - You have been confirmed to have classical Hodgkin's lymphoma with CD30 positive disease - Your disease has relapsed or is refractory to first-line treatment - You have measurable disease (at least one lymph node or mass 1.5 cm or larger) - You have no significant nerve damage (neuropathy less than grade 2) **You may NOT be eligible if...** - You have lymphocyte-predominant nodular Hodgkin's lymphoma (a different subtype) - You have previously received brentuximab vedotin - You are pregnant or breastfeeding - You have HIV, active hepatitis B or C - You have significant heart problems or serious nerve disease - You have had another cancer within the past 3 years - You have significant peripheral neuropathy (nerve pain or weakness) 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

DRUGInduction with Brentuximab vedotin (BV)

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

DRUGInduction 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

DRUGConsolidation 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

View Full Details on ClinicalTrials.gov

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NCT04378647


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