NCT01700751

Brentuximab Vedotin Prevention of (GVHD) After Unrelated Allogeneic Stem Cell Transplantation

A Pilot Study of Brentuximab Vedotin in the Prevention of Graft-Versus-Host Disease (GVHD) After Unrelated Allogeneic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies the safety and maximum tolerated dose of brentuximab vedotin when given with tacrolimus and methotrexate after unrelated allogeneic donor stem cell transplant in patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes. The addition of brentuximab vedotin to tacrolimus and methotrexate may result in a significant reduction of graft versus host disease in these patients.

Conditions

• Leukemia, Acute Myeloid
• Leukemia, Lymphoblastic,Acute
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	brentuximab vedotin

Timeline

• Start date: 2013-02-25
• Primary completion: 2015-11-11
• Completion: 2016-11-21
• First posted: 2012-10-04
• Last updated: 2019-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study