Actively Recruiting
BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant
Led by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Updated on 2024-02-26
150
Participants Needed
19
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of classical Hodgkin lymphoma CD30+ confirmed by biopsy
- Male or female aged 18 to 65 years
- Voluntary written informed consent given
- Female participants are post-menopausal for at least 1 year, surgically sterile, or agree to use two effective contraception methods or abstain from heterosexual intercourse during the study and 6 months after
- Male participants agree to use effective barrier contraception or abstain from heterosexual intercourse during the study and 6 months after
- ECOG performance status 0 to 2
- Measurable disease with lymphadenopathy or extranodal mass at least 1.5 cm
- No neuropathy grade 2 or higher
- Clinical lab values within protocol limits within 7 days before first study drug dose
You will not qualify if you...
- Diagnosis of lymphocyte predominant nodular Hodgkin's lymphoma
- Prior treatment with brentuximab vedotin
- Females who are lactating, breastfeeding, or have positive pregnancy test during screening or before first dose
- Serious medical or psychiatric illness interfering with treatment
- Known cerebral or meningeal disease including PML
- Symptomatic neurologic disease affecting daily living or requiring medication
- Peripheral neuropathy grade 2 or higher
- Specified cardiovascular conditions
- Active systemic infection requiring antibiotics within 2 weeks before first dose
- Incomplete prior chemotherapy or investigational treatment washout
- Known hypersensitivity to proteins or excipients in brentuximab vedotin
- Known HIV positive status
- Known hepatitis B or active hepatitis C infection
- Radiation therapy within 30 days prior to recruitment
- Major surgery within 28 days before randomization
- Other malignancy diagnosed or treated within 3 years, except nonmelanoma skin cancer or carcinoma in situ with complete resection
AI-Screening
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Trial Site Locations
Total: 19 locations
1
Institut Català D'Oncologia - Hospital Germans Trias I Pujol
Barcelona, Barceolna, Spain, 08916
Actively Recruiting
2
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
3
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
4
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Actively Recruiting
5
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
6
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
7
Institut Català D'Oncologia - Hospital Duran I Reynals
Barcelona, Spain, 08908
Actively Recruiting
8
Institut Català D'Oncologia
Barcelona, Spain, 08908
Actively Recruiting
9
Hospital Universitario de Cruces
Bilbao, Spain, 48903
Actively Recruiting
10
Hospital Universitario Virgen de Las Nieves
Granada, Spain, 18014
Actively Recruiting
11
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
12
Hospital Ramón Y Cajal
Madrid, Spain, 28034
Actively Recruiting
13
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
14
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
15
Hospital General Universitario J.M. Morales Meseguer
Murcia, Spain, 30008
Actively Recruiting
16
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
17
Hospital Universitario Virgen Del Rocío
Seville, Spain, 41013
Actively Recruiting
18
Hospital Universitario Y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
19
Hospital Clínico Universitario de Valencia
Valencia, Spain
Actively Recruiting
Research Team
L
lucia palacios, MSc
CONTACT
A
Angel Cedillo, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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