Clinical trial · Observational
A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin
Effectiveness and Safety for Re-treatment With Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) CD30+ Malignancies: a Retrospective Medical Chart Review Study in Spain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Participants in the study are adults with CD30-positive malignancies which include classical Hodgkin lymphoma (cHL), cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF) or primarily cutaneous anaplastic large cell lymphoma (pcALCL), or systemic anaplastic large cell lymphoma (sALCL). The main aims of the study are as follows: * to learn about the response rates of participants with relapsed or refractory CD30+ malignancies when re-treated with BV. * to check for side effects from re-treatment with BV. The study will take place in approximately 30 hospitals in Spain. The study doctors will review each participant's medical record at least 6 months after finishing the last dose of re-treatment with BV. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoma, T-Cell, Cutaneous | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants With CD30-positive Lymphoma
- description
- All participants diagnosed with relapsed/refractory (R/R) cHL, CTCL (mycosis fungoides \[MF\] and cutaneous anaplastic large cell lymphoma \[pcALCL\]) and sALCL with CD30 positive, and who have previously achieved a CR or PR with BV treatment and subsequently experienced disease progression/relapse and were administered BV retreatment will be observed retrospectively from their initiation of BV treatment until participant's inclusion date in the study or until treatment discontinuation due to toxicities or any cause. All study data will be collected retrospectively from the medical records.
- interventionNames
- Other: No Intervention
Primary outcomes (2)
- measure
- Overall Response Rate (ORR) as Assessed by Investigator Based on Positron Emission Tomography/Computerized Tomography (PET/CT) Status
- timeFrame
- Up to 6 months post-index date or death, whatever come first
- description
- ORR is the percentage of participants whose best overall response (graded by favorability in the order of clinical response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\], and not evaluable \[NE\]) from initiation of BV retreatment to the discontinuation or end of treatment according to response criteria is either CR or PR. ORR will be assessed by investigator using 5-point scale for visually assessing response on the pre and end-of-treatment PET/CT scans. The 5-point scale ranges from: 1 (No uptake), 2 (Uptake less than or equal to \[\<=\] mediastinum), 3 (Uptake greater than \[\>\] mediastinum but \<=liver), 4 (Uptake moderately \>liver), and 5 (Uptake markedly higher than liver and/no new lesions). Total score ranges from 0-5. In case of unavailability of PET/CT scans, ORR will be assessed as per Revised Criteria for Response Assessment for Malignant Lymphoma. Index date: eligible participants who start BV as retreatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed cHL, CTCL (MF and pcALCL) or sALCL with CD30 positive. 2. Previously treated with BV containing regimen, with evidence of objective response (determined by having achieved CR or PR), and subsequent disease progression or relapse after discontinuing treatment BV retreatment. 3. Participants with data of disease relapse or progression greater than or equal to (\>=) 6 months since the last dose of the first treatment with BV. 4. Participant with data available at the participating site since diagnosis of cHL, CTCL (MF and pcALCL) or sALCL. 5. Having received at least, two doses of BV as retreatment and having follow up information available at the site for a minimum period of six months or until death. Exclusion Criteria: There are no exclusion criteria for this study.
References
Publications (0)
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