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

Who is this study for? Adult patients with CD30-Positive Hodgkin's Lymphoma
What treatments are being studied? Brentuximab
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ Patients with classical HL CD30+ confirmed histologically (either at the time of diagnosis / at the time of first relapse) will be included in the trial

• Male or female patients 18 to 65 years of age

• Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

• Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse

• Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse

• ECOG 0 to 2

• Measurable disease at time of enrolment (lymphadenopathy/ extranodal mass of at least 1.5 cm)

• No evidence of neuropathy grade ≥2

• Clinical laboratory values as specified in the protocol below within 7 days before the first dose of study drug

Locations
Other Locations
Spain
Complexo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Institut Català D'Oncologia
RECRUITING
Barcelona
Institut Català D'Oncologia - Hospital Duran I Reynals
RECRUITING
Barcelona
Institut Català D'Oncologia - Hospital Germans Trias I Pujol
RECRUITING
Barcelona
Hospital Universitario de Cruces
RECRUITING
Bilbao
Hospital Universitario Virgen de Las Nieves
RECRUITING
Granada
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Ramón Y Cajal
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital General Universitario J.M. Morales Meseguer
RECRUITING
Murcia
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen Del Rocío
RECRUITING
Seville
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario Y Politécnico La Fe
RECRUITING
Valencia
Contact Information
Primary
lucia palacios, MSc
ensayosclinicos01@geltamo.com
+18599134526
Backup
Angel Cedillo, MSc
sc@geltamo.com
+34 91315780
Time Frame
Start Date: 2020-06-01
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 150
Treatments
Active_comparator: Induction ESHAP
3 Cycles ESHAP ( 21 days) : Etoposide \[40 mg/m2/ day IV, D1-4\], Solumedrol \[250 mg/day IV, D1-4\], High dose Ara-C \[2 g/m2 IV, D5\] Cisplatinum \[25 mg/m2/day IV, D1-4\]
Experimental: Induction BV-ESHAP
3 Cycles of Brentuximab VEedotin + ESHAP ( 21 days) : Etoposide \[40 mg/m2/ day IV, D1-4\], Solumedrol \[250 mg/day IV, D1-4\], High dose Ara-C \[2 g/m2 IV, D5\] Cisplatinum \[25 mg/m2/day IV, D1-4\] Brentuximab Vedotin \[1.8 mg/kg IV, D1\]
Sponsors
Leads: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

This content was sourced from clinicaltrials.gov

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