Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06756061 (A Nation-wide, Multi-center, Prospective, Randomized, Parallel-group, Open-label, Investigator Initiated Pilot Study to Evaluate Efficacy and Safety of Systemic Corticosteroid Plus Ruxolitinib as First-line Therapy in Patients With New-onset Moderate to Severe Chronic Graft-versus-host Disease), which is not on this map. Cited by 36 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Nation-wide, Multi-center, Prospective, Randomized, Parallel-group, Open-label, Investigator Initiated Pilot Study to Evaluate Efficacy and Safety of Systemic Corticosteroid Plus Ruxolitinib as First-line Therapy in Patients With New-onset Moderate to Severe Chronic Graft-versus-host Disease
Who cites it
36 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- Efficacy and Safety of Ibrutinib for Chronic Graft-Versus-Host Disease: A Systematic Review.Asian Pacific journal of cancer prevention : APJCP · 2023Pooled it
- A phase II study of belumosudil for chronic graft-versus-host disease in patients who failed at least one line of systemic therapy in China.BMC medicine · 2024Trial
- Chronic graft-versus-host disease after PTCy-based prophylaxis vs non-PTCy prophylaxis.Blood advances · 2026Article
- A Review of Modern Therapies and New Innovations in the Treatment of Cutaneous Graft-versus-Host Disease.Dermatology and therapy · 2026Review
- Comparison of GvHD prophylaxis regimens based on in vivo T-cell depletion (ATG vs. alemtuzumab) in patients with AML undergoing allo-HCT from unrelated donors with intermediate transplant conditioning intensity protocols: a registry study on behalf of the EBMT acute leukemia working party.Bone marrow transplantation · 2026Article
- Chronic graft-<I>versus</i>-host disease in the era of posttransplant cyclophosphamide.Haematologica · 2026Article
- Chronic graft-versus-host disease.Nature reviews. Disease primers · 2026Review
- Article
- Evaluation of Real-world treatment patterns in Japanese patients with cGVHD: A retrospective claims database study.International journal of hematology · 2026Article
- Advances in treatment of chronic graft-versus-host disease.International journal of hematology · 2026Review
- Patient-reported outcomes in chronic GVHD: instruments, clinical utility, and survivorship integration.Journal of patient-reported outcomes · 2026Review
- Advances in Cell Therapy for Chronic Graft-versus-Host Disease: Prophylactic and Therapeutic Perspectives.Clinical and experimental medicine · 2026Review
- [First-line treatment for chronic graft-versus-host disease: a real-world study].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026Article
- BTK Inhibition in Hematology: From CLL/SLL to Emerging Applications Across B-Cell and Immune Disorders.Biomolecules · 2026Review
- Chronic Graft-versus-host Disease, Part 2: Clinical Success and Roadmap to the Future.Transplantation · 2025Review
- A phase 2 study of single agent ibrutinib for first-line treatment of chronic graft-versus-host disease: A new paradigm and lessons learned.British journal of haematology · 2025Article
- Evaluating Axatilimab as a treatment option for chronic graft-versus-host disease.Immunotherapy · 2025Review
- FDA-approved therapies for chronic GVHD.Blood · 2025Review
- Pediatric Transplant and Cellular Therapy Consortium RESILIENT Conference on Pediatric Chronic Graft-Versus-Host Disease Survivorship After Hematopoietic Cell Transplantation: Part I. Phases of Chronic GVHD, Supportive Care, and Systemic Therapy Discontinuation.Transplantation and cellular therapy · 2025Article
- Modern-Era Challenges in the Clinical Management of Graft-Versus-Host Disease.Advances in experimental medicine and biology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 18 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo 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).
methodsPatients (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.
resultsNinety-five and 98 patients enrolled in the ibrutinib-prednisone and placebo-prednisone arms, respectively. At 48 weeks, response rates were 41% (ibrutinib-prednisone) and 37% (placebo-prednisone;
conclusionThere 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.