Evidence map›Paper›PMID 41117344›Full record

Trial reportHematological oncology2025

Randomized Phase II Study of Brentuximab-Vedotin With High-Dose Chemotherapy in CD30 Positive Lymphoma.

Christian Rausch, Ulrike Bacher, Manuela Rabaglio, Corinne Vorburger, Anke Klingenberg, Yara Banz, Michael Daskalakis, Thomas Pabst

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hematological oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03187210 (Brentuximab Vedotin and BeEAM High-dose Chemotherapy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03187210 phase1 / phase2suspendednot on this map

Brentuximab Vedotin and BeEAM High-dose Chemotherapy (B-BeEAM) With Autologous Stem Cell Transplantation for CD30+ Lymphomas, a Phase I/II Study

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2018 to 2025Enrolled20ConditionsLymphomaArmsBrentuximab Vedotin, BeEAM Regimen
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Christian RauschDepartment of Medicine III, LMU University Hospital, Munich, Germany.ORCID https://orcid.org/0000-0002-7364-5526
Ulrike BacherDepartment of Hematology and Central Hematological Laboratory, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland.
Manuela RabaglioDepartment of Medical Oncology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland.
Corinne VorburgerDepartment of Medical Oncology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland.
Anke KlingenbergDepartment of Medical Oncology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland.
Yara BanzInstitute of Tissue Medicine and Pathology, University of Bern, Bern, Switzerland.
Michael DaskalakisDepartment of Hematology and Central Hematological Laboratory, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland.
Thomas PabstDepartment of Medical Oncology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland.

Funding

Millenium Pharmaceuticals Inc.Takeda Pharmaceuticals International
6 · The paper itself

Abstract

Patients with Hodgkin lymphoma (HL) or peripheral T-cell lymphoma (PTCL) who relapse after high-dose chemotherapy (HDCT) have a dismal prognosis. Brentuximab-vedotin (BV) is a CD30-targeting antibody-drug-conjugate (ADC) used in first-line-, salvage-, and maintenance-therapy of HL, as well as first-line- and salvage-therapy of PTCL. In phase I of this trial, we could show that BV can safely be added to BeEAM-HDCT (bendamustine, etoposide, cytarabine and melphalan). Here, we report the randomized phase II part of the trial comparing BV-BeEAM to BeEAM alone (ClinicalTrials.gov: NCT03187210). Primary endpoint was 1-year disease-free survival. Inclusion of 42 patients was planned but the study was terminated early, after a futility analysis showed lack of benefit. Twenty-five patients (HL: 11, PTCL: 14) who were planned to undergo HDCT were included. Median age was 60 years. Patients had a median of two prior therapies, and 11 were previously exposed to BV. Patients in the standard-arm had higher disease stage and (PTCL only) higher IPI. Duration of hospitalization, recovery of neutrophils/platelets, and infections were not significantly different between arms. No treatment related death occurred. However, two patients in the BV-arm developed grade 3 pneumonitis. After 22 months median follow-up, overall response-rate, complete remission-rate, disease-free survival and overall survival did not differ between groups. Pre-planned subgroup-analyses (HL-only, PTCL-only, only those achieving CR) did not show benefit in any subgroup. In conclusion, adding BV to BeEAM does not improve outcomes after HDCT, and may increase pulmonary toxicity. Frequent prior exposure to BV may have limited the potential benefit of the combination.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsHodgkin DiseaseKi-1 AntigenLymphoma, T-Cell, PeripheralAdultAgedBrentuximab VedotinCytarabineEtoposideFemaleHumansImmunoconjugatesMaleMiddle AgedBrentuximab VedotinCytarabineEtoposideImmunoconjugatesKi-1 Antigenautologous stem‐cell transplantationbrentuximab‐vedotinhodgkin lymphomaperipheral T‐cell lymphomaphase II study

Identifiers

PMID41117344
PMCPMC12539077

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.