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NCT06615050
A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
Phase 3 trial testing Tacrolimus (Tac) in Graft-versus-host Disease (GVHD) in 572 participants. Currently enrolling.
17 January 2031
Quick facts
| Lead sponsor | Incyte Corporation |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 572 |
| Start date | 2 April 2025 |
| Primary completion | 17 January 2031 |
| Estimated completion | 17 January 2031 |
| Sites | 30 locations across United States |
Drugs / interventions tested
- Tacrolimus (Tac)
- Methotrexate (MTX) — full drug profile →
- Ruxolitinib (Rux) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Mycophenolate mofetil (MMF) — full drug profile →
Conditions studied
- Graft-versus-host Disease (GVHD) — all drugs for Graft-versus-host Disease (GVHD) →
Sponsor
Incyte Corporation — full company profile →
Who can join
18 and older, any sex, with Graft-versus-host Disease (GVHD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
New age GVHD prophylaxis regimens: what works for what donor and why.
Gooptu M, Koreth J. · · 2025 · PMID 41348045 · DOI 10.1182/hematology.2025000737
Verify or expand the search:
- PubMed search for NCT06615050
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tacrolimus (Tac)
Trials testing the same drug.
- NCT03674411 — Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy · Phase 2 · active not recruiting
- NCT02217410 — CCFZ533X2201 - PoC Study in de Novo Renal Transplantation · Phase 1, PHASE2 · completed
Other recruiting trials for Graft-versus-host Disease (GVHD)
Currently open trials in the same condition.
- NCT06626737 — Dapagliflozin in Allo-HCT for aGVHD · Phase 2 · recruiting
Other Incyte Corporation trials
Trials by the same sponsor.
- NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
- NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms · Phase 1 · recruiting
- NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
- NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting
- NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i · Phase 3 · recruiting
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 NCT06615050 (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 Incyte Corporation
- Last refreshed: 16 April 2026
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/NCT06615050.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing