PROACTIVE: Preventing Acute/Chronic GVHD With TocIlizumab Combined With GVHD Prophylaxis Post allogEneic Transplant

Phase 2 Completed 29 enrolled Medical College of Wisconsin National Cancer Institute (NCI) · collab National Heart, Lung, and Blood Institute (NHLBI) · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a phase II open-label trial designed to evaluate the efficacy of tocilizumab in improving GVHD-free/relapse-free survival (GRFS) after allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancy.

Timeline

Start: 2018-11-06
Primary completion: 2022-03-02
Completion: 2023-04-01

Publications

Results Chhabra S, Szabo A, Clurman A, McShane K, Waters N, Eastwood D, Samanas L, Fei T, Armijo G, Abedin S, Longo W, Hari P, Hamadani M, Shah NN, Runaas L, Jerkins JH, Van den Brink M, Peled JU, Drobyski WR. Mitigation of gastrointestinal graft-versus-host disease with tocilizumab prophylaxis is accompanied by preservation of microbial diversity and attenuation of enterococcal domination. Haematologica. 2023 Jan 1;108(1):250-256. doi: 10.3324/haematol.2022.281309. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tocilizumab	Monoclonal antibody	8 mg/kg	Intravenous
Background	Methotrexate	Small molecule	10 mg/m2	Intravenous
Background	Tacrolimus	Small molecule	0.03 mg/kg	Intravenous

PROACTIVE: Preventing Acute/Chronic GVHD With TocIlizumab Combined With GVHD Prophylaxis Post allogEneic Transplant

Summary

Timeline

Publications

Drugs

Indications