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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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)

Brief 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 Summary:

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.


Sponsor: Jason Robert Gotlib

Current Primary Outcome: Overall response rate per consensus international response criteria (rate of complete or partial remissions or clinical improvement) [ Time Frame: Up to 1 year ]

Will be estimated and its 95% confidence interval will be provided.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Immunohistochemical expression of CD30 on neoplastic mast cells in core biopsy samples by flow cytometry [ Time Frame: Up to 1 year ]
  • Total symptom score using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) [ Time Frame: Up to 1 year ]
  • Duration of response [ Time Frame: Time from first onset of confirmed response to the date of first documented and confirmed progression or death, assessed up to 1 year ]
    The Kaplan-Meier product-limit method will be used to summarize.
  • Time to response [ Time Frame: Time from start of treatment until the date of onset of a confirmed response, assessed up to 1 year ]
    The Kaplan-Meier product-limit method will be used to summarize.
  • Progression-free survival (PFS) [ Time Frame: Time from start of treatment to the date of the first documented and confirmed progression or death or institution of new therapy, assessed up to 1 year ]
    The Kaplan-Meier product-limit method will be used to summarize.
  • Type of adverse events measured by National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.03 [ Time Frame: Up to 1 year ]
  • Quality of life (QOL) score using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) [ Time Frame: Up to 1 year ]
  • Incidence of adverse events measured by National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.03 [ Time Frame: Up to 1 year ]
  • Severity of adverse events measured by National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.03 [ Time Frame: Up to 1 year ]
  • Seriousness of adverse events measured by National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.03 [ Time Frame: Up to 1 year ]
  • Relatedness of adverse events measured by National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.03 [ Time Frame: Up to 1 year ]


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: March 5, 2013
Date Started: September 2013
Date Completion: June 2017
Last Updated: December 13, 2016
Last Verified: December 2016