Abstract | PURPOSE: To present primary and final analyses from the randomized, double-blind, placebo-controlled, phase III iNTEGRATE study, which evaluated the safety and efficacy of ibrutinib with prednisone in previously untreated patients with chronic graft-versus-host disease (cGVHD). METHODS: Patients (age ≥ 12 years) with newly diagnosed moderate or severe cGVHD, requiring systemic corticosteroid therapy, and with no prior systemic treatment for cGVHD were randomly assigned 1:1 to receive ibrutinib 420 mg once daily plus prednisone, starting at 1 mg/kg once daily or placebo plus prednisone. The primary end point was response rate at 48 weeks according to 2014 National Institutes of Health Consensus Development Project Criteria. Other end points included event-free survival, duration of response, time to withdrawal of immunosuppressants, improvement in Lee cGVHD Symptom Scale score, overall survival (OS), and safety. RESULTS: CONCLUSION: There was no statistical difference observed in the primary and secondary end points with ibrutinib- prednisone treatment. No new safety signals were observed with ibrutinib treatment in previously untreated patients with cGVHD. The primary end point of iNTEGRATE was not met.
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Authors | David Bernard Miklos, Mohammad Abu Zaid, Julian P Cooney, Jörn C Albring, Mary Flowers, Alan P Skarbnik, Ibrahim Yakoub-Agha, Bor-Sheng Ko, Benedetto Bruno, Edmund K Waller, Jean Yared, Sang Kyun Sohn, Claude-Eric Bulabois, Takanori Teshima, David Jacobsohn, Hildegard Greinix, Ahmad Mokatrin, Yihua Lee, Justin T Wahlstrom, Lori Styles, Gerard Socie |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 41
Issue 10
Pg. 1876-1887
(04 01 2023)
ISSN: 1527-7755 [Electronic] United States |
PMID | 36608310
(Publication Type: Randomized Controlled Trial, Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Prednisone
- ibrutinib
- Piperidines
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Topics |
- Humans
- Child
- Prednisone
(adverse effects)
- Bronchiolitis Obliterans Syndrome
- Progression-Free Survival
- Piperidines
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Double-Blind Method
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