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NCT02086513
Phase I Trial of LDE225 for Steroid-refractory Chronic GVHD After Allogeneic HSCT
Terminated
Phase 1
Last updated 15 March 2018
What this trial tests
Phase 1 trial testing LDE225 in Graft Versus Host Disease in 17 participants. Terminated before completion.
Timeline
1 April 2014
Primary endpoint
1 December 2016
1 December 2016
1 December 2016
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 1 April 2014 |
| Primary completion | 1 December 2016 |
| Estimated completion | 1 December 2016 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- LDE225 — full drug profile →
Conditions studied
- Graft Versus Host Disease — all drugs for Graft Versus Host Disease →
Sponsor
Massachusetts General Hospital
Who can join
18 and older, any sex, with Graft Versus Host Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximum tolerated dose of LDE225 when given as treatment for steroid-refractory chronic GVHD.
Time frame: 2 years
Maximum tolerated dose of LDE225 when given as treatment for steroid-refractory chronic GVHD.
Sponsor's own description
This is a phase I trial of LDE225 for the treatment of steroid-refractory chronic Graft Versus Host Disease (GVHD).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas.
Jain S, Song R, Xie J. · · 2017 · cited 72× · PMID 28352196 · DOI 10.2147/ott.s130910 -
New Approaches for the Treatment of Chronic Graft-Versus-Host Disease: Current Status and Future Directions.
Saidu NEB, Bonini C, Dickinson A, Grce M, et al · · 2020 · cited 64× · PMID 33162993 · DOI 10.3389/fimmu.2020.578314 -
Phase 1 study of the Hedgehog pathway inhibitor sonidegib for steroid-refractory chronic graft-versus-host disease.
DeFilipp Z, Nazarian RM, El-Jawahri A, Li S, et al · · 2017 · cited 19× · PMID 29296838 · DOI 10.1182/bloodadvances.2017011239 -
Graft Versus Host Disease Clinical Trials: Is it Time for Patients Centered Outcomes to Be the Primary Objective?
Shaw BE. · · 2019 · cited 8× · PMID 30637541 · DOI 10.1007/s11899-019-0494-x -
Hedgehog Signaling Pathway in Fibrosis and Targeted Therapies.
Hu Y, Peng L, Zhuo X, Yang C, et al · · 2024 · cited 6× · PMID 39766192 · DOI 10.3390/biom14121485
Verify or expand the search:
- PubMed search for NCT02086513
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of LDE225
Trials testing the same drug.
- NCT01787552 — A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF · Phase 1, PHASE2 · completed
- NCT01708174 — A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB) · Phase 2 · completed
- NCT01327053 — A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma · Phase 2 · completed
Other recruiting trials for Graft Versus Host Disease
Currently open trials in the same condition.
- NCT07356245 — Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma · Phase 2 · recruiting
- NCT07006506 — A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant · Phase 2 · recruiting
- NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di · Phase 2 · recruiting
- NCT06705062 — Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment · Phase 3 · recruiting
- NCT06252870 — Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-trans · Phase 2 · recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
- NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
- NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
- NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
- NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02086513 (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 Massachusetts General Hospital
- Last refreshed: 15 March 2018
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/NCT02086513.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing