Phase 2
N=172
A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma
Lymphoma, B-Cell · Lymphoma, Large B-Cell, Diffuse · Lymphoma, Non-Hodgkin · Lymphoma, T-Cell
Bottom Line
View on ClinicalTrials.gov: NCT01421667 ↗Enrolled (actual)
172
Serious AEs
43.0%
Results posted
Oct 2016
Primary outcome: Primary: Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy — 41; 26; 44; 31 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- brentuximab vedotin (Drug); rituximab (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Seagen Inc.
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy |
41; 26; 44; 31 | — |
| PRIMARY Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab |
16; 15; 9; 2; 3; 3 | — |
| SECONDARY Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab |
50 | — |
| SECONDARY Complete Remission (CR) Rate by Investigator |
24; 16; 19; 12; 17 | — |
| SECONDARY Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis |
7.6; 1.6; 4.7; 4.7 | — |
| SECONDARY Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis |
NA; 7.2; NA; 11.6 | — |
| SECONDARY Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis |
2.5; 2.9; 4.0; 1.4 | — |
| SECONDARY Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression |
24; 16; 19; 12; 18; 11 | — |
| SECONDARY Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy |
32; 66; 52; 28; 62; 39 | — |
| SECONDARY Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1) |
35.6; 40.0; 40.1 | — |
| SECONDARY Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1) |
0.44; 0.91; 0.86 | — |
| SECONDARY Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1) |
4.71; 4.66; 3.95 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) |
1.90; 1.91; 1.94 | — |
| SECONDARY Baseline Soluble CD30 Expression |
1005.4; 229.4; 140.4 | — |
Summary
This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).
Eligibility Criteria
Inclusion Criteria
- Histologically-confirmed NHL (DLBCL only for Parts B and C)
- Relapsed or refractory disease following at least 1 prior systemic therapy
- Measurable disease of at least 1.5 cm as documented by CT
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Exclusion Criteria
- History of another primary invasive malignancy that has not been in remission for at least 3 years
- Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
- B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
- Known cerebral/meningeal disease
Data sourced from ClinicalTrials.gov (NCT01421667). 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.