Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)

Summary

To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

Timeline

Start

2017-05-11

Primary completion

2020-03-27

Completion

2021-07-12

Outcome

Missed primary endpoint

paper The primary end point of iNTEGRATE was not met. PMID 36608310 ↗

registry analysis (superiority test); Ibrutinib + Prednisone vs Placebo + Prednisone; p = 0.5384; Difference in Rates 0.043 (95% CI -0.094 to 0.181); NCT02959944 ↗

Publications

• Miklos DB, Abu Zaid M, Cooney JP, Albring JC, Flowers M, Skarbnik AP, Yakoub-Agha I, Ko BS, Bruno B, Waller EK, Yared J, Sohn SK, Bulabois CE, Teshima T, Jacobsohn D, Greinix H, Mokatrin A, Lee Y, Wahlstrom JT, Styles L, Socie G. Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study. J Clin Oncol. 2023 Apr 1;41(10):1876-1887. doi: 10.1200/JCO.22.00509. Epub 2023 Jan 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrutinib	Small molecule	420 mg	Oral
Background	Prednisone	Other / unclassified	1 mg/kg	Oral

Indications