NCT02270463

SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission

A Phase 1/2 Study of SL-401 as Consolidation Therapy for Adult Patients With Adverse Risk Acute Myeloid Leukemia in First CR, and/or Evidence of Minimal Residual Disease (MRD) in First CR

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Stemline Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, open-label, multicenter, dose escalation study designed to determine the maximum tolerated dose (MTD) of SL-401 in adult patients with acute myeloid leukemia, and to evaluate the safety profile of SL-401 at the MTD.

Detailed description

Patients who were in their first or second complete remission (CR) or complete remission with incomplete bone marrow recovery (CRi) after induction therapy were treated with SL-401, which was administered as a brief intravenous infusion for 5 consecutive days every 28 days for 6 or more cycles. Stage 1 consisted of a period in which patients were treated with SL-401 at 3 dose levels. During Stage 2, patients with minimal residual disease (MRD) in their bone marrow were treated at a MTD or maximum tested dose in which multiple dose-limiting toxicities were not observed (identified in Stage 1).

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Tagraxofusp-erzs	Tagraxofusp-Erzs administered by IV infusion at doses of 7, 9, and 12 µg/kg/day

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2014-10-21
• Last updated: 2024-10-17
• Results posted: 2024-08-21

Locations

7 sites across 1 country: United States