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GVHD - Graft-Versus-Host DiseasePhase 2FRONTJAK-001NCT06756061

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

A Phase 2 study testing Prednisone + Jakavi(ruxolitinib) and Prednisone in people with GVHD - Graft-Versus-Host Disease and Neoplasms, run by Byung-Sik Cho at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Prednisone + Jakavi(ruxolitinib) and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteSouth Korea
Study dates
15 Jan 2025to 31 Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

[Inclusion Data]

  1. Adult men and women aged 19 or older based on the date of signing on the informed consent form
  2. On the screening visit, those who are diagnosed of a moderate to severe chronic graft-versus-host disease according to 2014 NIH consensus criteria -Moderate: At least one of the following conditions: >1 point for at least three organs >2 points for at least one organ except the lungs >1 point for the lungs -Severe: At least one of the following conditions: >3 points for at least one organ
  • At least 2 points for the lungs
  1. Those who have no history of systemic treatment for chronic graft-versus-host disease and now need systemic corticosteroid treatment
  2. Those whose ECOG (Eastern Cooperative Oncology Group) performance status is 0 to 2.
  3. Regardless of the donor (matched sibling-family donor, matched unrelated donor, or partially matched family donor), those who have successfully taken same-type stem cell transplantation (alloSCT) from the marrow, peripheral blood stem cell, or cord blood
  4. Those who voluntarily agree on participation in this clinical trial

[Exclusion Data]

  1. Those who meet the following criteria in laboratory tests during the screening and randomization visits
  • Those whose platelet count is less than or equal to 25,000/mm3 without blood transfusion
  • Those whose absolute neutrophil count is less than or equal to 1,000/mm3
  • Those whose total bilirubin > 3 x ULN for any reason other than chronic graft-versus-host disease
  1. Those with gastrointestinal troubles that hinder the intake and absorption of IMPs and concomitant medicines (systemic corticosteroid) (e.g.: signs such as ulcerative disease, unregulated nausea, vomiting, diarrhea, malabsorption, etc. or small intestine removal)
  2. Those with a history of graft-versus-host disease treatment
  • Corticosteroid administration is permitted for chronic graft-versus-host disease treatment within 72 hours before the randomization visit
  • Except those who had therapeutic or preventive use of systemic corticosteroids and/or systemic immunosuppressants (CNI, MMF) for acute graft-versus-host disease (In case of prednisone administration for maintenance, only 0.5 mg/kg/day or less is permitted)
  1. Those to whom the treatment for chronic graft-versus-host disease cannot begin as prednisone ≥ 0.5 mg/kg/day
  2. Those whose same-type stem cell transplantation (alloSCT) has been confirmed as engraft-failed within 6 months before the screening visit
  3. Those with an experience of ruxolitinib administration for acute graft-versus-host disease treatment (however, the patient may participate on the assumption that the response to the acute graft-versus-host disease treatment reaches the level of complete or partial response and that there is no ruxolitinib administration history within 4 weeks before the randomization visit. In addition, if ruxolitinib administration was for another disease, the patient may participate unless there is no history of ruxolitinib administration within 4 weeks before the randomization visit.)
  4. Those who suffer chronic graft-versus-host disease after an unscheduled donor lymphocyte infusion for proactive treatment to prevent the recurrence of a malignant tumor (Participation is allowed if the scheduled lymphocyte infusion is performed as part of the transplantation procedure, not for the prevention of the recurrence of a malignant tumor.)
  5. Those found to have the following history in the screening visit:
  • Relapsed primary malignancy
  • Those found to involve an unregulated sinusoidal obstruction syndrome
  • Those with a history of progressive multifocal leukoencephalopathy (PML)
  • Nephropathy whose creatinine clearance rate is lower than 30 mL/min (Cockroft Gault equation)
  • Infections that are clinically active and uncontrolled, requiring treatment, including significant bacteria, fungi, viruses, or parasitic infections. (However, if there are no signs of progression at the time of screening due to appropriate treatment, the infection is considered controlled. The progression of infection is defined by hemodynamic instability due to sepsis, new symptoms caused by the infection, worsening physical signs, or radiological findings. A persistent fever without other signs or symptoms is not interpreted as progressive infection.)
  • Active tuberculosis
  • HIV-infected individual
  • Active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV) that the investigator views as significant
  • Cardiovascular disease that the investigator considers as clinically significant (acute cardiac infarction (within 6 months before randomization), NYHA class III or IV congestive heart failure, unstable angina (within 6 months before randomization), clinically significant symptomatic cardiac arrhythmia (e.g.: continued ventricular tachycardia, clinically significant level 2 or 3 AV blockage with no pacemaker used), unregulated hypertension)
  1. Those allergic or sensitive to additives of IMPs and concomitant medicines (systemic corticosteroid) or similar compounds
  2. Patients with genetic problems such as galactose intolerance, lapp lactase deficiency, glucose - galactose malabsorption, etc.
  3. Those who are administrated with more than 200 mg of Fluconazole per day
  4. Those being treated with systemic medicines that may hinder blood coagulation or platelet functions such as aspirin, heparin, and warfarin (However, those whose aspirin administration does not exceed 150 mg/day may participate.)
  5. Pregnant or breast-feeding women
  6. Those who do not agree on utilizing proper methods of contraception(e.g. a copper intrauterine device (copper loop), an intrauterine device containing hormones, condoms, a vasectomy, tubal surgery, a spermicide, a vagina-inserted contraceptive, a subdermal implant, an injectable contraceptive, a female condom, oral contraceptive, etc.) during the period of this clinical trial(the period of IP administration and at least 30 days after IP administration ends)
  7. Those who have participated in another clinical trial within 30 days before the screening visit and have a history of IMP administration/medical equipment application (However, if the investigator views such a previous trial as not affecting this clinical trial's efficacy and safety assessment such as observational study or retrospective study, the subject may participate.)
  8. Those whose participation in this clinical trial is viewed as inappropriate in the investigator's opinion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ByungSik Cho, M.D. & Ph.D. contact

+82-2-2258-6072

cbscho@catholic.ac.kr

South Korea1 site, 1 recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, Banpo-daero/Seocho-gu, 06591

    Daehun Kwag, M.D., +82 2-2258-6051, kdh@catholic.ac.kr

    Geunhwa Choi, Bachelor's degree, +82 2-2258-9529, crcchoi82@naver.com

    Recruiting

Other trials in South Korea

About this study

Official title: A Nation-wide, Multi-center, Prospective, Randomized, Parallel-group, Open-label, Investigator Initiated Pilot Study to Evaluate Efficacy and Safety of Systemic Corticosteroid Plus Ruxolitinib as First-line Therapy in Patients With New-onset Moderate to Severe Chronic Graft-versus-host Disease

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.

Read more

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.

Being tested
Prednisone + Jakavi(ruxolitinib), Prednisone
Keywords
GvHD-Graft-Versus-Host-Disease, ruxolitinib, first-line
Medical subject headings
Graft vs Host Disease, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prednisone + Jakavi(ruxolitinib)Drug

    The experimental group will receive ruxolitinib 10 mg orally twice daily (BID) and prednisone (or equivalent) at a dosage of 1 mg/kg/day.

    Subjects are orally administered with an investigational medicinal product (IMP) according to their designated treatment group for 48 weeks, and the investigator may adjust the dosage of IMPs based on symptoms of the target disease. (However, after the 48-week mark, participants in the ruxolitinib treatment group may continue to receive ruxolitinib for an additional maximum of 2 years, based on the investigator's judgment regarding the need for ongoing treatment. The total duration of ruxolitinib administration will not exceed 3 years.)

  • PrednisoneDrug

    The control group will receive prednisone (or equivalent) at a dosage of 1 mg/kg/day.

    Subjects are orally administered with an investigational medicinal product (IMP) according to their designated treatment group for 48 weeks, and the investigator may adjust the dosage of IMPs based on symptoms of the target disease.

Study groups in NCT06756061
Study groupRoleWhat they receive
Prednisone + Jakavi(ruxolitinib)ExperimentalThe experimental group will receive ruxolitinib 10 mg orally twice daily (BID) and prednisone (or equivalent) at a dosage of 1 mg/kg/day. Subjects are orally administered with an investigational medicinal product (IMP) according to their designated treatment group for 48 weeks, and the investigator may adjust the dosage of IMPs based on symptoms of the target disease. (However, after the 48-week mark, participants in the ruxolitinib treatment group may continue to receive ruxolitinib for an additional maximum of 2 years, based on the investigator's judgment regarding the need for ongoing treatment. The total duration of ruxolitinib administration will not exceed 3 years.)
Receives: Drug: Prednisone + Jakavi(ruxolitinib)
PrednisoneActive comparatorThe control group will receive prednisone (or equivalent) at a dosage of 1 mg/kg/day. Subjects are orally administered with an investigational medicinal product (IMP) according to their designated treatment group for 48 weeks, and the investigator may adjust the dosage of IMPs based on symptoms of the target disease.
Receives: Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate(ORR)

    ORR was defined as the proportion of participants in each study arm achieving either a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) assessments in accordance with the National Institutes of Health Consensus Criteria. Response scoring was compared against the organ score at the time of randomization. CR was characterized by the complete resolution of all cGvHD-related signs and symptoms across all evaluable organs, without the initiation or addition of new systemic therapies. PR was defined as improvement in at least one organ (e.g., an increase of 1 or more points on a 4- to 7-point scale, or an increase of 2 or more points on a 10- to 12-point scale) with no progression in other organs or sites and without the need for initiation or addition of new systemic therapies. Participants requiring additional systemic therapies for earlier progression, mixed response, or non-response were classified as not achieving response.

    Measured: on 48 week

Secondary outcomes (9)

  1. Ratio of subjects who are found steroid-refractory or steroid-dependent

    All corticosteroid dosages administered to participants, along with any dose adjustments made during the study, were documented to evaluate participants meeting specific criteria.Steroid-refractory chronic GvHD(SR-cGVHD) was defined as either progression of cGVHD while receiving prednisone at a dose of ≥1mg/kg/day for at least 1 week or stable cGVHD while on≥0.5mg/kg/day or ≥1mg/kg every other day(EOD) for at least 1 month.Response criteria were based on the National Institutes of Health Consensus Criteria.Progression was defined as worsening in any organ or site or the need to initiate or add new systemic therapies.Participants who did not meet the criteria for overall response or progression were categorized as stable.Steroid-dependent participants were defined as those for whom at least two corticosteroid tapering attempts, spaced at least 8 weeks apart, had failed, requiring corticosteroid doses>0.25 mg/kg/day or >0.5mg/kg/day EOD to prevent recurrence or progression of symptoms.

    Measured: on Weeks 1, 4, 24, 36 and 48

  2. Overall Response Rate (ORR) based on the NIH Consensus Criteria on Weeks 24 and 36

    ORR was defined as the proportion of participants in each study arm achieving either a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) assessments in accordance with the National Institutes of Health Consensus Criteria. Response scoring was compared against the organ score at the time of randomization. CR was characterized by the complete resolution of all cGvHD-related signs and symptoms across all evaluable organs, without the initiation or addition of new systemic therapies. PR was defined as improvement in at least one organ (e.g., an increase of 1 or more points on a 4- to 7-point scale, or an increase of 2 or more points on a 10- to 12-point scale) with no progression in other organs or sites and without the need for initiation or addition of new systemic therapies. Participants requiring additional systemic therapies for earlier progression, mixed response, or non-response were classified as not achieving response.

    Measured: on Weeks 24 and 36

  3. Failure-free Survival (FFS)

    Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.

    Measured: for 48 weeks

  4. Duration of Response (DOR)

    DOR was defined as the time from first response until cGvHD progression, death, or the date of change/addition of systemic therapies for cGvHD and as assessed for responders only. Response was based on cGvHD disease assessments (National Institutes of Health consensus criteria). Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1.

    Measured: for 48 weeks

  5. Ratio of subjects whose daily dosage of systemic corticosteroid is reduced as much as at least 50%

    All corticosteroid dosages administered to participants, along with any dose adjustments made during the study, were documented to evaluate participants who achieved a ≥ 50% reduction in their daily corticosteroid dose.

    Measured: compared to the baseline on Week 48

  6. Ratio of subjects whose daily dosage of systemic corticosteroid is reduced

    All corticosteroid dosages administered to participants, along with any dose adjustments made during the study, were documented for assessment of participants with any degree of reduction in daily corticosteroid dose.

    Measured: compared to the baseline on Week 48

  7. Time up to the point of stopping systemic immunosuppressant administration (concomitant medicines other than IMPs)

    All systemic immunosuppressant dosages administered to participants, along with any dose adjustments during the study, were documented to assess participants who successfully discontinued all systemic immunosuppressants. Participants who were classified as having completely tapered off immunosuppressants were those who permanently ceased their use as recorded in the dose administration records and did not restart treatment within the same interval. Participants who discontinued immunosuppressants and remained in follow-up were also considered tapered off, with a recorded dose of 0 in subsequent intervals unless they restarted immunosuppressant treatment or withdrew from the main treatment period.

    Measured: for 48 weeks

  8. Change in FACT-BMT((Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The FACT-BMT is a 50-item self-report questionnaire that measures the effect of a therapy on domains including physical, functional, social/family, and emotional well-being, together with additional concerns relevant for bone marrow transplantation participants. The questions were based on a 5-point Likert scale, where 0 corresponds to "not at all" and 4 corresponds to "very much." The higher the final score, the better the quality of life. The FACT-BMT total score ranges from 0 to 148.

    Measured: compared to the baseline on Week 24, 36 and 48

  9. Change in EQ-5D-5L(European Quality of Life 5 Dimension) score

    The EQ-5D-5L is a descriptive classification consisting of five dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. The five-level version (no problems, slight problems, moderate problems, severe problems, and extreme problems) uses a 5-point Likert scale, with 1 being no problems and 5 being extreme problems.

    Measured: compared to the baseline on Week 24, 36 and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2025
  2. Study start15 Jan 2025
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06756061
Sponsor's protocol ID
CINC424DKR01T
Acronym
FRONTJAK-001
Status last verified
Feb 2025
First submitted
13 Dec 2024
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • DeFilipp Z, Couriel DR, Lazaryan A, Bhatt VR, Buxbaum NP, Alousi AM, Olivieri A, Pulanic D, Halter JP, Henderson LA, Zeiser R, Gooley TA, MacDonald KPA, Wolff D, Schultz KR, Paczesny S, Inamoto Y, Cutler CS, Kitko CL, Pidala JA, Lee SJ, Socie G, Sarantopoulos S, Pavletic SZ, Martin PJ, Blazar BR, Greinix HT. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: III. The 2020 Treatment of Chronic GVHD Report. Transplant Cell Ther. 2021 Sep;27(9):729-737. doi: 10.1016/j.jtct.2021.05.004. Epub 2021 Jun 11.

    PubMed 34147469

  • Martin PJ, Lee SJ, Przepiorka D, Horowitz MM, Koreth J, Vogelsang GB, Walker I, Carpenter PA, Griffith LM, Akpek G, Mohty M, Wolff D, Pavletic SZ, Cutler CS. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. The 2014 Clinical Trial Design Working Group Report. Biol Blood Marrow Transplant. 2015 Aug;21(8):1343-59. doi: 10.1016/j.bbmt.2015.05.004. Epub 2015 May 15.

    PubMed 25985921

  • Malard F, Labopin M, Yakoub-Agha I, Chantepie S, Guillaume T, Blaise D, Tabrizi R, Magro L, Vanhove B, Blancho G, Moreau P, Gaugler B, Chevallier P, Mohty M. Rituximab-based first-line treatment of cGVHD after allogeneic SCT: results of a phase 2 study. Blood. 2017 Nov 16;130(20):2186-2195. doi: 10.1182/blood-2017-05-786137. Epub 2017 Sep 1.

    PubMed 28864814

  • Rongvaux-Gaida D, Dupuis M, Poupon J, Djebrani-Oussedik N, Lemonnier C, Rieger F. High Response Rate and Corticosteroid Sparing with Arsenic Trioxide-Based First-Line Therapy in Chronic Graft-versus-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation. Transplant Cell Ther. 2022 Oct;28(10):679.e1-679.e11. doi: 10.1016/j.jtct.2022.07.004. Epub 2022 Jul 10.

    PubMed 35830931

  • Lazaryan A, Lee S, Arora M, Kim J, Betts BC, Khimani F, Nishihori T, Bejanyan N, Liu H, Kharfan-Dabaja MA, Locke FL, Gonzalez R, Jain MD, Davila ML, Perez LE, Mishra A, Perez Perez A, Balke K, Ayala E, Ochoa L, Castaneda Puglianini O, Faramand R, Alsina M, Elmariah H, Nieder ML, Fernandez H, Anasetti C, Pidala JA. A phase 2 multicenter trial of ofatumumab and prednisone as initial therapy for chronic graft-versus-host disease. Blood Adv. 2022 Jan 11;6(1):259-269. doi: 10.1182/bloodadvances.2021005552.

    PubMed 34649279

  • Zeiser R, von Bubnoff N, Butler J, Mohty M, Niederwieser D, Or R, Szer J, Wagner EM, Zuckerman T, Mahuzier B, Xu J, Wilke C, Gandhi KK, Socie G; REACH2 Trial Group. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med. 2020 May 7;382(19):1800-1810. doi: 10.1056/NEJMoa1917635. Epub 2020 Apr 22.

    PubMed 32320566

  • Martin PJ, Storer BE, Rowley SD, Flowers ME, Lee SJ, Carpenter PA, Wingard JR, Shaughnessy PJ, DeVetten MP, Jagasia M, Fay JW, van Besien K, Gupta V, Kitko C, Johnston LJ, Maziarz RT, Arora M, Jacobson PA, Weisdorf D. Evaluation of mycophenolate mofetil for initial treatment of chronic graft-versus-host disease. Blood. 2009 May 21;113(21):5074-82. doi: 10.1182/blood-2009-02-202937. Epub 2009 Mar 6.

    PubMed 19270260

  • Hamilton BK. Updates in chronic graft-versus-host disease. Hematology Am Soc Hematol Educ Program. 2021 Dec 10;2021(1):648-654. doi: 10.1182/hematology.2021000301.

    PubMed 34889364

  • Lee SJ, Vogelsang G, Flowers ME. Chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2003 Apr;9(4):215-33. doi: 10.1053/bbmt.2003.50026.

    PubMed 12720215

  • Flowers ME, Martin PJ. How we treat chronic graft-versus-host disease. Blood. 2015 Jan 22;125(4):606-15. doi: 10.1182/blood-2014-08-551994. Epub 2014 Nov 14.

    PubMed 25398933

  • Axt L, Naumann A, Toennies J, Haen SP, Vogel W, Schneidawind D, Wirths S, Moehle R, Faul C, Kanz L, Axt S, Bethge WA. Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplant. 2019 Nov;54(11):1805-1814. doi: 10.1038/s41409-019-0544-y. Epub 2019 May 14.

    PubMed 31089279

  • Koc S, Leisenring W, Flowers ME, Anasetti C, Deeg HJ, Nash RA, Sanders JE, Witherspoon RP, Storb R, Appelbaum FR, Martin PJ. Therapy for chronic graft-versus-host disease: a randomized trial comparing cyclosporine plus prednisone versus prednisone alone. Blood. 2002 Jul 1;100(1):48-51. doi: 10.1182/blood.v100.1.48.

    PubMed 12070007

  • Arora M, Wagner JE, Davies SM, Blazar BR, Defor T, Enright H, Miller WJ, Weisdorf DF. Randomized clinical trial of thalidomide, cyclosporine, and prednisone versus cyclosporine and prednisone as initial therapy for chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2001;7(5):265-73. doi: 10.1053/bbmt.2001.v7.pm11400948.

    PubMed 11400948

  • Penack O, Marchetti M, Ruutu T, Aljurf M, Bacigalupo A, Bonifazi F, Ciceri F, Cornelissen J, Malladi R, Duarte RF, Giebel S, Greinix H, Holler E, Lawitschka A, Mielke S, Mohty M, Arat M, Nagler A, Passweg J, Schoemans H, Socie G, Solano C, Vrhovac R, Zeiser R, Kroger N, Basak GW. Prophylaxis and management of graft versus host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation. Lancet Haematol. 2020 Feb;7(2):e157-e167. doi: 10.1016/S2352-3026(19)30256-X.

    PubMed 32004485

  • Pidala J, Kurland B, Chai X, Majhail N, Weisdorf DJ, Pavletic S, Cutler C, Jacobsohn D, Palmer J, Arai S, Jagasia M, Lee SJ. Patient-reported quality of life is associated with severity of chronic graft-versus-host disease as measured by NIH criteria: report on baseline data from the Chronic GVHD Consortium. Blood. 2011 Apr 28;117(17):4651-7. doi: 10.1182/blood-2010-11-319509. Epub 2011 Feb 25.

    PubMed 21355084

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prednisone + Jakavi(ruxolitinib) and Prednisone in people with GVHD - Graft-Versus-Host Disease and Neoplasms, run by Byung-Sik Cho at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ByungSik Cho, M.D. & Ph.D. (+82-2-2258-6072, cbscho@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate(ORR) (time frame: on 48 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06756061, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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FRONTJAK-001 Clinical Trial NCT06756061 | AzTrials