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aGVHD ProphylaxisGecacitinibNCT07440654

Efficacy and Safety of Gecacitinib Hydrochloride in Prophylaxis Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelofibrosis

A study testing Gecacitinib in people with aGVHD Prophylaxis, run by Nanfang Hospital, Southern Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Gecacitinib hydrochloride is a novel JAK/ACVR1 inhibitor approved for intermediate- and high-risk myelofibrosis (MF). Clinical and real-world data demonstrate significant efficacy in spleen reduction, symptom relief, and anemia improvement, with favorable safety and tolerability. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
aGVHD Prophylaxis
What is being tested?
Gecacitinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Mar 2026to 1 Dec 2029
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent form (ICF), and be aged ≥ 18 years at the time of signing.
  • Diagnosis of primary myelofibrosis (PMF) according to the 2016 WHO criteria (DIPSS intermediate-2/high risk, MPISS70 high/very high risk, or RR6 high risk), or post-ET/PV secondary myelofibrosis (MYSEC intermediate-2/high risk), with intention to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
  • Recipient with myelofibrosis scheduled to receive myeloablative conditioning allo-HSCT from a matched unrelated donor, matched sibling donor, or haploidentical donor.
  • Karnofsky Performance Scale score ≥ 60.
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
  • Male participants must agree to abstinence or use barrier contraception throughout the study.
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  • Female participants of childbearing potential must have a negative pregnancy test and agree to use two effective methods of contraception throughout the study.
  • Ability to swallow tablets.
  • Ability to comply with study and follow-up procedures.

Who cannot join

  • Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy.
  • Hepatic insufficiency defined as bilirubin ≥ 2 × upper limit of normal (ULN), except for patients with a history of Gilbert Syndrome.
  • Renal impairment defined as serum creatinine > 2 mg/dL.
  • Cardiac dysfunction defined as left ventricular ejection fraction (LVEF) ≤ 45%.
  • Pulmonary dysfunction defined as forced expiratory volume in the first second (FEV1) or diffusing capacity for carbon monoxide (DLCO) (corrected for hemoglobin) ≤ 50% of predicted value.
  • Chronic or active infection requiring systemic therapy during the peri-transplant and post-transplant period.
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  • Diagnosis of another active malignancy within the past 12 months, except for adequately treated non-melanoma skin cancer, adequately treated melanoma of grade 2 or below, or cervical intraepithelial neoplasia. Active malignancy is defined as malignancy undergoing active treatment.
  • Any significant clinical or laboratory abnormality that may compromise safety evaluation, such as:
  • Uncontrolled diabetes mellitus (fasting blood glucose > 13.9 mmol/L);
  • Hypertension uncontrolled by two or more antihypertensive agents (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg);
  • Peripheral neuropathy of grade ≥ 2 per NCI-CTCAE v5.0.
  • Pre-transplant diagnosis of gastrointestinal impairment or disease that may affect drug absorption, including ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or history of gastrectomy or intestinal resection.
  • Cholestatic disease or sinusoidal obstruction syndrome / hepatic veno-occlusive disease at screening (defined as persistent bilirubin abnormality and progressive organ dysfunction not due to graft-versus-host disease).
  • Active and uncontrolled viral infection at screening, including CMV, EBV, HIV (positive anti-HIV antibody), HBV (positive HBsAg or positive HBV-DNA), HCV (positive anti-HCV antibody or positive HCV-RNA).
  • Active tuberculosis within 6 months prior to screening.
  • History of epilepsy or use of psychotropic or sedative medications at screening.
  • Female patients who are pregnant, breastfeeding, or planning pregnancy, or who cannot use effective contraception throughout the study; male patients who do not use condoms during dosing and for 2 days (approximately 5 half-lives) after the last dose.
  • History of malignancy other than the transplanted tumor within the previous 5 years.
  • Use of anticoagulant or antiplatelet agents (except low-molecular-weight heparin).
  • Presence of other severe diseases that, in the investigator's opinion, may affect patient safety or compliance.
  • Suspected hypersensitivity to geltrectinib hydrochloride, its analogs, or any of its excipients.
  • Participation in another clinical trial of an investigational drug or medical device within 4 weeks prior to screening.
  • Any other condition that, in the investigator's judgment, renders the patient ineligible for the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Na Xu Nanfang Hospital, Southern Medical University contact

020-62787238

nfyyec@163.com

About this study

Official title: Efficacy and Safety of Gecacitinib Hydrochloride Combined With Rabbit Anti-Human Thymocyte Immunoglobulin (ATG) in Prophylaxis Acute Graft-Versus-Host Disease (aGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) in Patients With Myelofibrosis (MF)

Gecacitinib hydrochloride is a novel JAK/ACVR1 inhibitor approved for intermediate- and high-risk myelofibrosis (MF). Clinical and real-world data demonstrate significant efficacy in spleen reduction, symptom relief, and anemia improvement, with favorable safety and tolerability. Preclinical studies confirm that this agent can mitigate GVHD and suppress inflammation. MF patients undergoing allo-HSCT are at risk of delayed engraftment and aGVHD. Based on the immunomodulatory effects of JAK inhibitors, gecacitinib is expected to have potential for aGVHD prophylaxis. This study aims to evaluate the efficacy and safety of geltrectinib hydrochloride combined with ATG for preventing aGVHD in MF patients after allo-HSCT.

Being tested
Gecacitinib
Keywords
Gecacitinib, Myelofibrosis (MF), aGVHD prophylaxis, allo-HSCT
Medical subject headings
Primary Myelofibrosis

What participants receive

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

  • GecacitinibDrug

    Also called Jaktinib

    (i) Rabbit anti-human thymocyte immunoglobulin (ATG): administered on Days -4 to -2.(ii) Cyclosporine A: initiated on Day -9 through Day +180, tapered gradually after Day +90.(iii) Mycophenolate mofetil (MMF): administered at 0.5 g twice daily (bid) from Day -9 to Day +30.(iv) Geltrectinib hydrochloride: administered between Day +6 and Day +28 post-engraftment at a dose of 50 mg twice daily (bid).

Study groups in NCT07440654
Study groupRoleWhat they receive
Gecacitinib Hydrochloride in Combination with Rabbit Anti-human Thymocyte Immunoglobulin (ATG)ExperimentalNot described
Receives: Drug: Gecacitinib

What is being measured

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

  1. Incidence of grade 3-4 aGVHD

    Proportion of patients with grade 3-4 acute graft-versus-host disease (aGVHD) within 14 weeks.

    Measured: 14 weeks.

Secondary outcomes (1)

  1. Incidence of poor graft function

    In the setting of complete donor chimerism, mild or moderate cytopenia exists in at least two hematopoietic cell lineages (ANC ≤ 1.5×10⁹/L; platelet count ≤ 30×10⁹/L, Hb ≤ 85 g/L) and persists for more than 2 weeks.

    Measured: 14 weeks

Timeline

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

  1. First posted27 Feb 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Sep 2029 (estimated)
  4. Study completion1 Dec 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07440654
Sponsor's protocol ID
NFEC-2026-043
Other IDs
GCA-aGVHD-002
Acronym
Gecacitinib
Status last verified
Feb 2026
First submitted
23 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Saad A, de Lima M, Anand S, Bhatt VR, Bookout R, Chen G, Couriel D, Di Stasi A, El-Jawahri A, Giralt S, Gutman J, Ho V, Horwitz M, Hsu J, Juckett M, Kharfan-Dabaja MA, Loren A, Meade J, Mielcarek M, Moreira J, Nakamura R, Nieto Y, Roddy J, Satyanarayana G, Schroeder M, Tan CR, Tzachanis D, Burn J, Pluchino L. Hematopoietic Cell Transplantation, Version 2.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2020 May 1;18(5):599-634. doi: 10.6004/jnccn.2020.0021.

    PubMed 32519831

  • Zhang Y, Zhou H, Zhuang J, et al. A randomized, double-blind, phase 3 study of jaktinib versus hydroxyurea (HU) in patients (pts) with intermediate-2 or high-risk myelofibrosis (MF). Journal of Clinical Oncology 41, no. 16_suppl (2023): 7015-7015.

  • De Togni E, Cole O, Abboud R. Janus kinase inhibition in the treatment and prevention of graft-versus-host disease. Front Immunol. 2024 Feb 6;15:1304065. doi: 10.3389/fimmu.2024.1304065. eCollection 2024.

    PubMed 38380328

Questions about this trial

What is this clinical trial studying?

A study testing Gecacitinib in people with aGVHD Prophylaxis, run by Nanfang Hospital, Southern Medical University.

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

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

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 Na Xu Nanfang Hospital, Southern Medical University (020-62787238, nfyyec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of grade 3-4 aGVHD (time frame: 14 weeks.). 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 NCT07440654, which also lists 3 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 27 Feb 2026.

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