A Study of Brentuximab Vedotin (SGN-35) in CD30-Positive Systemic Mastocytosis With or Without an Associated Hematological Clonal Non-Mast Cell Lineage Disease (AHNMD)
I. To evaluate the response rate to SGN-35 (brentuximab vedotin) in patients with tumor
necrosis factor receptor superfamily, member 8 (CD30+) advanced systemic mastocytosis (SM)
(ASM or mast cell leukemia [MCL] with or without an associated hematological clonal non-mast
cell lineage disease [AHNMD]).
I. To evaluate the tolerability and safety profile of SGN-35 in patients with SM.
II. To evaluate expression of CD30 on neoplastic mast cells before and during therapy with
III. To evaluate changes in mastocytosis related symptom scores and quality of life (QOL)
using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPNSAF).
IV. To evaluate the duration of response (DoR) and time to response (TTR). V. To evaluate
progression-free survival (PFS).
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment
repeats every 21 days for 8 courses in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up every 6 weeks for 1 year and
then every 12 weeks thereafter.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate per consensus international response criteria (rate of complete or partial remissions or clinical improvement)
Will be estimated and its 95% confidence interval will be provided.
Up to 1 year
Stanford University Hospitals and Clinics
United States: Federal Government
|Stanford University Cancer Institute||Stanford, California 94305|