BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant
BRESELIBET
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
1 other identifier
interventional
150
1 country
19
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2020
Longer than P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
February 26, 2024
February 1, 2024
6.2 years
May 4, 2020
February 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
PET-CT result
PET-CT negative, Deauville scores 1 and 2
4-6 weeks after the Cycle 3 started (each cycle is 21 days)
Secondary Outcomes (4)
progression-free survival (PFS)
At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Duration of response
At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Overall Survival (OS)
At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Duration of response (DOR)
At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Other Outcomes (1)
Safety and tolerability
At the end of the 3 years of of last dose of consoldation Brentuximab VEdotin treatment
Study Arms (2)
Induction ESHAP
ACTIVE COMPARATOR3 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 \[25 mg/m2/day IV, D1-4\]
Induction BV-ESHAP
EXPERIMENTAL3 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 \[1.8 mg/kg IV, D1\]
Interventions
3 cycles ESHAP plus antibody-drug conjugate brentuximab vedotin (BV) at a dose of 1.8 mg/kg IV
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
Up to 13 or 16 cycles of antibody-drug conjugate brentuximab vedotin (BV) at doses of 1.8 mg/kg iv every 21 days)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Lymphocyte predominant nodular Hodgkin's lymphoma
- Prior treatment with brentuximab vedotin
- Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
- Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
- Symptomatic neurologic disease compromising normal activities of daily living or requiring medic
- Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
- Known history of any of the following cardiovascular conditions defined in the protocol
- Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
- Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives (or 28 days if the half-lives are unknown) of last dose of that prior treatment
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
- Known human immunodeficiency virus (HIV) positive
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
- Focal radiation therapy within 30 days prior to study recruitment
- Major surgery within 28 days prior to randomization
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Institut Català D'Oncologia - Hospital Germans Trias I Pujol
Barcelona, Barceolna, 08916, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Institut Català D'Oncologia - Hospital Duran I Reynals
Barcelona, 08908, Spain
Institut Català D'Oncologia
Barcelona, 08908, Spain
Hospital Universitario de Cruces
Bilbao, 48903, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18014, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Ramón Y Cajal
Madrid, 28034, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital General Universitario J.M. Morales Meseguer
Murcia, 30008, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Del Rocío
Seville, 41013, Spain
Hospital Universitario Y Politécnico La Fe
Valencia, 46026, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Sureda, PhD
Institut Català d'Oncologia, Hospital Duran i Reynals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 7, 2020
Study Start
June 1, 2020
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
August 30, 2026
Last Updated
February 26, 2024
Record last verified: 2024-02