Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease

Summary

This research trial is designed to study the safety and effectiveness of combining the study drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft), treat the recipient's body as "foreign" and attack the cells in the recipient's body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. Acute GVHD can be severe and if severe, potentially fatal to the transplant recipient. Acute GVHD usually happens within the first several months after transplant. The goal of this research is to develop a safer and more effective treatment for acute GVHD, and particularly for acute GVHD that affects the gastrointestinal (or GI) tract, with the ultimate goal being safer and more effective transplant therapies for blood cancers such as leukemia, lymphoma, and multiple myeloma.

Timeline

Start

2016-08

Primary completion

2020-12-10

Completion

2021-11-21

Publications

• Al Malki MM, London K, Baez J, Akahoshi Y, Hogan WJ, Etra A, Choe H, Hexner E, Langston A, Abhyankar S, Ponce DM, DeFilipp Z, Kitko CL, Adekola K, Reshef R, Ayuk F, Capellini A, Chanswangphuwana C, Eder M, Eng G, Gandhi I, Grupp S, Gleich S, Holler E, Javorniczky NR, Kasikis S, Kowalyk S, Morales G, Ozbek U, Rosler W, Spyrou N, Yanik G, Young R, Chen YB, Nakamura R, Ferrara JLM, Levine JE. Phase 2 study of natalizumab plus standard corticosteroid treatment for high-risk acute graft-versus-host disease. Blood Adv. 2023 Sep 12;7(17):5189-5198. doi: 10.1182/bloodadvances.2023009853.

Drugs

Indications