Phase 2
Completed N=102
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
Disease, Hodgkin
Source: ClinicalTrials.gov NCT00848926 ↗
Enrolled (actual)
102
Serious AEs
24.5%
Results posted
Oct 2011
Primary outcomePrimary: Objective Response Rate by Independent Review Group — 75 percent of participants
Summary
This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate by Independent Review Group |
75 | — |
| SECONDARY Complete Remission Rate by Independent Review Group |
33 | — |
| SECONDARY Duration of Objective Response by Kaplan-Meier Analysis |
6.7 | — |
| SECONDARY Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis |
27.9 | — |
| SECONDARY Progression-free Survival by Kaplan-Meier Analysis |
5.6 | — |
| SECONDARY Overall Survival |
40.5 | — |
| SECONDARY Adverse Events by Severity, Seriousness, and Relationship to Treatment |
100; 94; 56; 25; 14; 20 | — |
| SECONDARY Hematology Laboratory Abnormalities >/= Grade 3 |
35; 7; 6; 20; 12; 7 | — |
| SECONDARY Chemistry Laboratory Abnormalities >/= Grade 3 |
14; 1; 1; 1; 7; 2 | — |
| SECONDARY Area Under the Curve |
88 | — |
| SECONDARY Maximum Serum Concentration |
35 | — |
| SECONDARY Time of Maximum Serum Concentration |
0.02 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.
- Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
- Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography.
- At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.
Exclusion Criteria
- Previous treatment with brentuximab vedotin.
- Previously received an allogeneic transplant.
- Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
- History of another primary malignancy that has not been in remission for at least 3 years.
- Known cerebral/meningeal disease.
Data sourced from ClinicalTrials.gov (NCT00848926). 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.