NCT02614560

A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients

A Phase 1/2 Study of Vadastuximab Talirine Administered in Sequence With Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine in sequence with standard treatments before a planned stem cell transplant, or as maintenance therapy after a stem cell transplant. The main purpose of the study is to find the best dose and determine the anti-leukemic activity of vadastuximab talirine, given either pre- or post-allogeneic stem cell transplant (alloSCT) for adults with relapsed or refractory AML. This will be determined by assessing the safety and tolerability of vadastuximab talirine. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Fludarabine	30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
DRUG	Melphalan	Melphalan 140 mg/m2 intravenously, 2 days before the transplant
DRUG	vadastuximab talirine	Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
DRUG	vadastuximab talirine	Post-allo (after stem cell transplant) given on Day 1 of each cycle

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-02-10
• Completion: 2017-09-14
• First posted: 2015-11-25
• Last updated: 2019-01-09
• Results posted: 2019-01-09

Locations

11 sites across 1 country: United States