NCT06756061 (FRONTJAK-001) is a Phase 2 clinical trial of Prednisone + Jakavi(ruxolitinib) in GVHD - Graft-Versus-Host Disease, sponsored by Byung-Sik Cho.

Who is sponsoring NCT06756061?

NCT06756061 is sponsored by Byung-Sik Cho.

What drugs are being tested in NCT06756061?

Interventions in NCT06756061: Prednisone + Jakavi(ruxolitinib), Prednisone.

What condition does NCT06756061 study?

NCT06756061 studies GVHD - Graft-Versus-Host Disease, Neoplasms, Haematopoietic Stem Cell Transplantation.

Is NCT06756061 still recruiting?

NCT06756061 is currently recruiting now. Last updated 19 February 2025.

Last reviewed 2025-02-19 · How we verify

NCT06756061: FRONTJAK-001

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

Comparing the Therapeutic Effects of Using Ruxolitinib and Steroids Concurrently to Steroids Alone as Initial Treatment In Patients Diagnosed With Chronic Graft-versus-host Disease at a Grade of Moderate or Higher Severity

Recruiting now Phase 2 Last updated 19 February 2025

What this trial tests

Phase 2 trial testing Prednisone + Jakavi(ruxolitinib) in GVHD - Graft-Versus-Host Disease in 88 participants. Currently enrolling.

Timeline

15 January 2025

Primary endpoint
1 November 2027

31 August 2029

Quick facts

Lead sponsor	Byung-Sik Cho
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	88
Start date	15 January 2025
Primary completion	1 November 2027
Estimated completion	31 August 2029
Sites	1 location across South Korea

Drugs / interventions tested

Prednisone + Jakavi(ruxolitinib) — full drug profile →
Prednisone (prednisone) — full drug profile →

Conditions studied

GVHD - Graft-Versus-Host Disease — all drugs for GVHD - Graft-Versus-Host Disease →
Neoplasms — all drugs for Neoplasms →
Haematopoietic Stem Cell Transplantation — all drugs for Haematopoietic Stem Cell Transplantation →

Sponsor

Byung-Sik Cho — full company profile →

Who can join

19 and older, any sex, with GVHD - Graft-Versus-Host Disease or Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic graft-versus-host disease (cGVHD) is a complication that occurs in 30-40% of recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT) and is a major cause of late non-relapse mortality. In cases where the initial treatment response is inadequate, irreversible tissue damage often persists, making it a fatal complication that significantly reduces quality of life even for long-term survivors. Therefore, the success of first-line treatment is crucial, but to date, there are no approved drugs specifically for the first-line treatment of chronic graft-versus-host disease. Besides corticosteroids, which have been used palliatively for over 50 years, there are no proven effective treatments available. Against this background, this study was designed to explore the potential of new treatments as first-line therapy for chronic graft-versus-host disease, where effective treatment options are currently lacking. Initially, the objective response rate will be analyzed at the 48-week mark based on the NIH Consensus Criteria (Lee 2015). Additionally, the study will evaluate the proportion of patients with steroid-resistant or steroid-dependent conditions, the objective response rate(ORR), failure-free survival(FFS), duration of response(DOR), and the proportion of patients who have reduced corticosteroids. Furthermore, the differences in treatment effects between the two groups of patients will be analyzed based on safety endpoints, including adverse events, laboratory tests, physical examinations, and vital signs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for GVHD - Graft-Versus-Host Disease

Currently open trials in the same condition.

NCT06715046 — Cell Free DNA Profiling As a Tool to Monitor Clinically-Relevant Events in Allogeneic Hematopoietic Stem Cell Transplant · 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 NCT06756061 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Byung-Sik Cho
Last refreshed: 19 February 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/NCT06756061.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing