Clinical trial · Interventional
A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
A Phase 2, Multicenter, Single-arm Study of Retreatment With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classic Hodgkin Lymphoma (cHL) or CD30-expressing Peripheral T Cell Lymphoma (PTCL)
NCT03947255CI-TRIAL-00070454terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study stopped early due to low patient accrual.
Summary
Brief summary (as posted)
This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brentuximab vedotin
- interventionNames
- Drug: brentuximab vedotin
Primary outcomes (3)
- measure
- Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria
- timeFrame
- Up to 18.3 months
- description
- Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR
- measure
- Number of Participants With Adverse Events
- timeFrame
- Up to 36 months
- description
- An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL * Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment * Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin * Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique * Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 * Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug Exclusion Criteria: * Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity * Existing Grade 2 or higher peripheral neuropathy * Previously refractory to treatment with brentuximab vedotin * History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose * History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy * Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD * Active cerebral/meningeal disease * History of progressive multifocal leukoencephalopathy (PML) * Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug * Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
References
Publications (0)
Data not yet available
No reference posted for this study.