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NCT05348096
Efficacy and Safety of Low-dose Ibrutinib and Itraconazole in Chronic Graft Versus Host Disease
Phase 2 trial testing Low-dose ibrutinib in Chronic Graft-versus-host-disease in 13 participants. Status unknown.
1 April 2023
Quick facts
| Lead sponsor | Hospital Universitario Dr. Jose E. Gonzalez |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 1 April 2022 |
| Primary completion | 1 April 2023 |
| Estimated completion | 1 August 2023 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Low-dose ibrutinib — full drug profile →
Conditions studied
- Chronic Graft-versus-host-disease — all drugs for Chronic Graft-versus-host-disease →
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Who can join
18 and older, any sex, with Chronic Graft-versus-host-disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chronic graft-versus-host disease (cGVHD) affects 30 to 70% of Allogeneic Hematopoietic Cell Transplantation, decreases the quality of life, and increases mortality. First-line treatments for cGVHD are steroids, however, up to 50% of patients do not respond to treatment. There is no well-defined second-line treatment for cGVHD, but ibrutinib, a Bruton tyrosine kinase inhibitor, has been successfully used in phase 2 clinical trials for moderate to severe steroid-refractory cGVHD and has been shown to be safe, showing rates of response of 69% at a median follow-up of 26 months. Therefore, ibrutinib was approved by the FDA for the treatment of steroid-refractory cGVHD. Also, it is known that ibrutinib is metabolized by cytochrome isoenzyme 3A4 and that itraconazole is a potent inhibitor of this hepatic isoenzyme. Therefore, the investigators hypothesized that in subjects with newly diagnosed cGVHD and in patients with steroid-refractory cGVHD, low-dose ibrutinib in combination with itraconazole might be effective and safe.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pharmacokinetic Boosting of Kinase Inhibitors.
Westra N, Touw D, Lub-de Hooge M, Kosterink J, et al · · 2023 · cited 17× · PMID 37111635 · DOI 10.3390/pharmaceutics15041149 -
Metabolic Reprogramming and Potential Therapeutic Targets in Lymphoma.
Pang Y, Lu T, Xu-Monette ZY, Young KH. · · 2023 · cited 16× · PMID 36982568 · DOI 10.3390/ijms24065493
Verify or expand the search:
- PubMed search for NCT05348096
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Graft-versus-host-disease
Currently open trials in the same condition.
- NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
- NCT06843408 — A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD · Phase 1, PHASE2 · recruiting
- NCT06821542 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease Afte · Phase 3 · active not recruiting
- NCT06585774 — A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease · Phase 3 · recruiting
- NCT06388564 — A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Dia · Phase 2 · recruiting
Other Hospital Universitario Dr. Jose E. Gonzalez trials
Trials by the same sponsor.
- NCT07401992 — Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis · Phase 4 · recruiting
- NCT06758375 — Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients · Phase 2 · recruiting
- NCT06904599 — Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment · Phase 2 · recruiting
- NCT07039877 — Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients · Phase 2 · recruiting
- NCT06209190 — Safety and Feasibility of TMLI as Conditioning Regimen in Allogeneic Hematopoietic Stem-cell Transplantation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05348096 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitario Dr. Jose E. Gonzalez
- Last refreshed: 27 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05348096.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing