NCT01807598

Brentuximab Vedotin in Treating Patients With Advanced Systemic Mastocytosis or Mast Cell Leukemia

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Jason Robert Gotlib · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies brentuximab vedotin in treating patients with advanced systemic mastocytosis or mast cell leukemia. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them

Detailed description

Brentuximab vedotin is an antibody with a covalently attached toxin. The antibody portion targets the protein CD30 on the surface of cells, and the toxin acts against those cells. 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.

Conditions

• Aggressive Systemic Mastocytosis
• Mast Cell Leukemia
• Systemic Mastocytosis

Interventions

Type	Name	Description
DRUG	Brentuximab vedotin

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2013-03-08
• Last updated: 2019-01-29
• Results posted: 2019-01-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study