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Brentuximab Vedotin for Hodgkin Lymphoma Treatment 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

PHASE2 · Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · NCT04378647

This study is testing if a combination of Brentuximab Vedotin and chemotherapy can help people with relapsed or hard-to-treat Hodgkin Lymphoma do better before they have a transplant.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorGrupo Español de Linfomas y Transplante Autólogo de Médula Ósea (other)
Drugs / interventionsbrentuximab, chemotherapy, radiation
Locations19 sites (Barcelona, Barceolna and 18 other locations)
Trial IDNCT04378647 on ClinicalTrials.gov

What this trial studies

This phase IIb open-label trial evaluates the efficacy of Brentuximab Vedotin combined with ESHAP chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma. Participants are randomized to receive either the combination treatment or ESHAP alone, followed by consolidation therapy with Brentuximab Vedotin for those who achieve a metabolic complete remission. The study aims to assess overall response rates and long-term outcomes in this patient population. It involves multiple treatment cycles and monitoring of clinical outcomes post-treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with histologically confirmed classical Hodgkin Lymphoma who have relapsed or refractory disease.

Not a fit: Patients who do not have classical Hodgkin Lymphoma or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and reduce the need for autologous stem cell transplantation in Hodgkin Lymphoma patients.

How similar studies have performed: Previous studies have shown promising results with Brentuximab Vedotin in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

Exclusion Criteria:

* 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
* Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease.
* Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

Where this trial is running

Barcelona, Barceolna and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hodgkin Lymphoma, Adult

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.