Phase 2
N=131
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
Hodgkin Disease · Peripheral T Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01716806 ↗Enrolled (actual)
131
Serious AEs
34.7%
Results posted
Jun 2024
Primary outcome: Primary: Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) — 93; 95; 85 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- brentuximab vedotin (Drug); bendamustine (Drug); dacarbazine (Drug); nivolumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seagen Inc.
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) |
93; 95; 85 | — |
| PRIMARY ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D) |
86 | — |
| PRIMARY ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F) |
60; 43 | — |
| SECONDARY Number of Participants With Adverse Events |
27; 22; 20; 21; 30; 7 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
2; 1; 0; 1; 1; 0 | — |
| SECONDARY Complete Response Rate |
70; 64; 75; 67; 30; 43 | — |
| SECONDARY Duration of Complete Response |
7.4; NA; NA; NA; NA; NA | — |
| SECONDARY Duration of Objective Response |
7.6; 46.0; NA; NA; 7.4; NA | — |
| SECONDARY Progression-free Survival |
8.6; 47.2; 32.5; NA; 8.7; 10.5 | — |
| SECONDARY Disease Control Rate |
100; 95; 85; 90; 77; 57 | — |
| SECONDARY ORR According to Lugano Criteria Per BICR (Parts E and F) |
67; 43 | — |
| SECONDARY B Symptom Resolution Rate |
100; 100; 86; 67; 0; 0 | — |
| SECONDARY Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) |
23; 20; 16; 17; 24; 6 | — |
| SECONDARY Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only) |
0; 4; 1; 5 | — |
| SECONDARY Overall Survival (Parts E and F Only) |
31.8; 12.6 | — |
Summary
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.
Eligibility Criteria
Inclusion Criteria
- Parts A, B, C, and D: 60 years of age or older
- Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
- Treatment-naive patients with CD30-expressing PTCL (Part F)
- Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
- Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
- A CIRS score of 10 or greater
- Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
- Measurable disease of at least 1.5 cm as documented by radiographic technique
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
Exclusion Criteria
- Symptomatic neurologic disease compromising IADLs or requiring medication
- History of progressive multifocal leukoencephalopathy
- Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
- Concurrent use of other investigational agents
- Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
- History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
- Part D only:
- Received any prior immune-oncology therapy
- History of known or suspected autoimmune disease
- Prior allogeneic stem cell transplant
- History of cerebral vascular event within 6 months of first dose of study drug
- Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
- Known history of pancreatitis
- Parts D, E, and F only:
- Known cerebral/meningeal disease related to the underlying malignancy
- Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
Data sourced from ClinicalTrials.gov (NCT01716806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.