Clinical Trial: SL-401 in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia

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

Official Title: SL-401 in Patients With Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Brief Summary: This is a non-randomized, open-label, multi center study. A cycle of therapy is 5 consecutive days every 21 days for 6 or more cycles. Stage I will consist of a brief run-in period in which patients with BPDCN (previously untreated and previously treated) and AML (persistent/recurrent and previously untreated) will be treated with SL-401 at 3 dose levels. During Stage 2, two cohorts of BPDCN and AML patients will be treated at the maximum tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage 1).

Detailed Summary:
Sponsor: Stemline Therapeutics, Inc.

Current Primary Outcome: Primary Outcome Measures include Efficacy and Safety [ Time Frame: Please refer to the Study Completion date ]

Original Primary Outcome: Define Maximum Tolerated Dose or the Maximum Tested Dose (MTD) [ Time Frame: 6 months ]

The primary objectives are to determine the maximum tolerated dose (MTD), or the maximum tested dose where multiple dose-limiting toxicities (DLTs) are not observed, of SL-401, and to characterize the safety profile of SL-401 at the MTD or maximum tested dose.


Current Secondary Outcome:

Original Secondary Outcome:

  • Characterize pharmacokinetics (PK) activity SL-401 [ Time Frame: 6 months ]
    The concentration of SL-401 in plasma samples will be determined by a sensitive and specific sandwich ELISA method. The collection of blood serum or PK analysis will be at cycles 1 and 3 at the following time points, immediately prior to the start of infusion, immediately after end of infusion, then 15, 30, 45, 60,90, 120, 180, and 240 minutes after the completion of the infusion.
  • Characterize the immunogenicity of SL-401 [ Time Frame: 6 months ]
    Whole Blood Samples will be collected as EDTA plasma for the detection and characterization of SL-401 reactive antibodies. Blood Samples will be collected at each cycle; Days 1, 15, and 21.


Information By: Stemline Therapeutics, Inc.

Dates:
Date Received: March 13, 2014
Date Started: September 2014
Date Completion: December 2016
Last Updated: July 1, 2016
Last Verified: July 2016