NCT04669210 (PTCyRuxo) is a Phase 2 clinical trial of Ruxolitinib in Graft-versus-host-disease, sponsored by St. Petersburg State Pavlov Medical University.

Who is sponsoring NCT04669210?

NCT04669210 is sponsored by St. Petersburg State Pavlov Medical University.

What drugs are being tested in NCT04669210?

Interventions in NCT04669210: Ruxolitinib, Tacrolimus, Mycophenolate Mofetil.

What condition does NCT04669210 study?

NCT04669210 studies Graft-versus-host-disease, Stem Cell Transplant Complications, Acute Myeloid Leukemia, Acute Lymphoid Leukemia.

Is NCT04669210 still recruiting?

NCT04669210 is currently completed. Last updated 4 July 2025.

Last reviewed 2025-07-04 · How we verify

NCT04669210: PTCyRuxo

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT

Completed Phase 2 Last updated 4 July 2025

What this trial tests

Phase 2 trial testing Ruxolitinib in Graft-versus-host-disease in 128 participants. Completed in 28 March 2025.

Timeline

3 November 2020

Primary endpoint
27 February 2023

28 March 2025

Quick facts

Lead sponsor	St. Petersburg State Pavlov Medical University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	128
Start date	3 November 2020
Primary completion	27 February 2023
Estimated completion	28 March 2025
Sites	2 locations across Russia

Drugs / interventions tested

Ruxolitinib (RUXOLITINIB) — full drug profile →
Tacrolimus (TACROLIMUS) — full drug profile →
Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →

Conditions studied

Graft-versus-host-disease — all drugs for Graft-versus-host-disease →
Stem Cell Transplant Complications — all drugs for Stem Cell Transplant Complications →
Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Acute Lymphoid Leukemia — all drugs for Acute Lymphoid Leukemia →

Sponsor

St. Petersburg State Pavlov Medical University

Who can join

Adults 18 to 70, any sex, with Graft-versus-host-disease or Stem Cell Transplant Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is multicenter investigator-initiated randomized open-label phase II clinical trial to compare prophylaxis of graft versus host disease treated with tacrolimus and mycophenolate mofetil versus ruxolitinib after post-transplant cyclophosphamide. In total 128 patients will be included in the study. After inclusion into the study and performing of transplantation patients will be randomized in 1:1 proportion in two arms (64 patients per arm): arm A will include patients who will be treated with cyclophosphamide and ruxolitinib for GVHD prophylaxis; arm B will include patients who will be treated with cyclophosphamide, tacrolimus and MMF for GVHD prophylaxis. After the end of the treatment patients will be followed-up during two years.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004
Untwining Anti-Tumor and Immunosuppressive Effects of JAK Inhibitors-A Strategy for Hematological Malignancies?
Klein K, Stoiber D, Sexl V, Witalisz-Siepracka A. · · 2021 · cited 22× · PMID 34073410 · DOI 10.3390/cancers13112611
How to improve the outcomes of elderly acute myeloid leukemia patients through allogeneic hematopoietic stem cell transplantation.
Jiang S, Yan H, Lu X, Wei R, et al · · 2023 · cited 1× · PMID 37207218 · DOI 10.3389/fimmu.2023.1102966
A randomized, multicenter phase II trial to compare prophylaxis of graft versus host disease with tacrolimus and mycophenolate mofetil versus ruxolitinib after post-transplant cyclophosphamide.
Moiseev I, Drokov M, Kitaeva Y, Zhogolev D, et al · · 2026 · PMID 42066960 · DOI 10.1016/j.jtct.2026.04.042

Verify or expand the search:

Other trials of Ruxolitinib

Trials testing the same drug.

NCT07498205 — Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts · Phase 4 · not yet recruiting
NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
NCT07311746 — Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07340138 — Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis · Phase 1 · not yet recruiting
NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting

Other recruiting trials for Graft-versus-host-disease

Currently open trials in the same condition.

NCT06008808 — Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release S · Phase 1 · recruiting
NCT06321003 — SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography · recruiting
NCT03842696 — Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood an · Phase 1, PHASE2 · active not recruiting
NCT04337515 — A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant · NA · recruiting

Other St. Petersburg State Pavlov Medical University trials

Trials by the same sponsor.

NCT07238712 — Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies · Phase 2 · recruiting
NCT06871007 — Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma · Phase 1, PHASE2 · enrolling by invitation
NCT05757466 — Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma · Phase 2 · unknown
NCT06022952 — The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents · NA · unknown
NCT05591716 — Evaluation of the Efficacy and Safety of Unimodal Bilateral Flexible Ureteroscopy. · NA · unknown

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 NCT04669210 (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 St. Petersburg State Pavlov Medical University
Last refreshed: 4 July 2025

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/NCT04669210.

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