Phase 2
N=58
A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
Lymphoma, Large-Cell, Anaplastic · Lymphoma, Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT00866047 ↗Enrolled (actual)
58
Serious AEs
43.1%
Results posted
Oct 2011
Primary outcome: Primary: Objective Response Rate by Independent Review Group — 86 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- brentuximab vedotin (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Seagen Inc.
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate by Independent Review Group |
86 | — |
| SECONDARY Complete Remission Rate by Independent Review Group |
59 | — |
| SECONDARY Duration of Objective Response by Kaplan-Meier Analysis |
13.2 | — |
| SECONDARY Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis |
26.3 | — |
| SECONDARY Progression-free Survival by Kaplan-Meier Analysis |
14.6 | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Adverse Events by Severity, Seriousness, and Relationship to Treatment |
58; 53; 36; 25; 11; 16 | — |
| SECONDARY Hematology Laboratory Abnormalities >/= Grade 3 |
17; 3; 10; 7; 3 | — |
| SECONDARY Chemistry Laboratory Abnormalities >/= Grade 3 |
13; 1; 3; 4; 1; 1 | — |
| SECONDARY Area Under the Curve |
98 | — |
| SECONDARY Maximum Serum Concentration |
37 | — |
| SECONDARY Time of Maximum Serum Concentration |
0.02 | — |
Summary
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.
Eligibility Criteria
Inclusion Criteria
- Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
- Documented anaplastic lymphoma kinase (ALK) status.
- 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 and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
- Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
- 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.
- Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
- Known cerebral/meningeal disease.
Data sourced from ClinicalTrials.gov (NCT00866047). 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.