~1 spots leftby Apr 2026

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

Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Seagen Inc.
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

PG

Phillip Garfin, MD, PhD

Principal Investigator

Seagen Inc.

Eligibility Criteria

Inclusion Criteria

Relapsed/refractory acute myeloid leukemia (AML) except for acute promyelocytic leukemia
Eastern Cooperative Oncology Group status of 0 or 1
Adequate baseline renal and hepatic function
See 4 more

Treatment Details

Interventions

  • vadastuximab talirine (Monoclonal Antibodies)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Pre-allo (before stem cell transplant)Experimental Treatment3 Interventions
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Group II: Post-allo (after stem cell transplant)Experimental Treatment1 Intervention
Post-allo vadastuximab talirine

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seagen Inc.

Lead Sponsor

Trials
212
Recruited
73,800+
Founded
1997
Headquarters
Bothell, USA
Known For
Antibody-Drug Conjugates
Top Products
Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)
Dr. Roger Dansey profile image

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein profile image

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University