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)
PRIMARY OBJECTIVES:
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]).
SECONDARY OBJECTIVES:
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
SGN-35.
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).
OUTLINE:
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
toxicity.
After completion of study treatment, patients are followed up every 6 weeks for 1 year and
then every 12 weeks thereafter.
Interventional
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
No
Jason Gotlib
Principal Investigator
Stanford University Hospitals and Clinics
United States: Federal Government
HEMMPD0016
NCT01807598
June 2013
Name | Location |
---|---|
Stanford University Cancer Institute | Stanford, California 94305 |