Phase 2
Completed N=110
A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
Disease, Hodgkin · Non-Hodgkin's Lymphoma · Lymphoma, Non-Hodgkin
Source: ClinicalTrials.gov NCT00947856 ↗
Enrolled (actual)
110
Serious AEs
22.7%
Results posted
May 2014
Primary outcomePrimary: Objective Response Rate by Investigator — 60; 91; 33; 68 percentage of retreatment experiences
Summary
This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate by Investigator |
60; 91; 33; 68 | — |
| PRIMARY Adverse Events by Severity, Seriousness, and Relationship to Treatment |
75; 31; 65; 27; 37; 16 | — |
| PRIMARY Laboratory Abnormalities >/= Grade 3 |
29; 12; 16; 8; 3; 3 | — |
| SECONDARY Duration of Objective Response by Kaplan-Meier Analysis |
9.2; 8.8; NA; 9.2 | — |
| SECONDARY Progression-free Survival by Kaplan-Meier Analysis |
9.9; 12.9; 4.4; 9.9 | — |
| SECONDARY Overall Survival |
NA; NA; NA; NA; NA | — |
| SECONDARY Incidence of Antitherapeutic Antibodies |
15; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Participated in a previous brentuximab vedotin study.
- CD30-positive hematologic malignancy.
- At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.
Exclusion Criteria
Withdrew consent to participate in any prior brentuximab vedotin study.
Data sourced from ClinicalTrials.gov (NCT00947856). 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. Informational only — not medical advice.