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

February 23, 2026 updated by: Nanfang Hospital, Southern Medical University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Na Xu Nanfang Hospital, Southern Medical University
  • Phone Number: 020-62787238
  • Email: nfyyec@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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:

    1. Uncontrolled diabetes mellitus (fasting blood glucose > 13.9 mmol/L);
    2. Hypertension uncontrolled by two or more antihypertensive agents (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg);
    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gecacitinib Hydrochloride in Combination with Rabbit Anti-human Thymocyte Immunoglobulin (ATG)
Drug: Gecacitinib
(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).
Other Names:
  • Jaktinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade 3-4 aGVHD
Time Frame: 14 weeks.
Proportion of patients with grade 3-4 acute graft-versus-host disease (aGVHD) within 14 weeks.
14 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of poor graft function
Time Frame: 14 weeks
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.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Saad, Ayman, Marcos de Lima, Sarah Anand, Vijaya Raj Bhatt, Ryan Bookout, George Chen, Daniel Couriel et al. "Hematopoietic Cell Transplantation, Version 2.2020, NCCN Clinical Practice Guidelines in Oncology." Journal of the National Comprehensive Cancer Network 18, no. 5 (2020): 599-634.
  • 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.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2026-043
  • GCA-aGVHD-002 (Other Grant/Funding Number: Suzhou Zejing Biopharmaceutical Co., Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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