NCT07440654

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
42mo left

Started Mar 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Dec 2029

First Submitted

Initial submission to the registry

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

February 23, 2026

Last Update Submit

February 23, 2026

Conditions

aGVHD Prophylaxis

Keywords

GecacitinibMyelofibrosis (MF)aGVHD prophylaxisallo-HSCT

Outcome Measures

Primary Outcomes (1)

  • Incidence of grade 3-4 aGVHD

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

    14 weeks.

Secondary Outcomes (1)

  • Incidence of poor graft function

    14 weeks

Study Arms (1)

Gecacitinib Hydrochloride in Combination with Rabbit Anti-human Thymocyte Immunoglobulin (ATG)

EXPERIMENTAL
Drug: Gecacitinib

Interventions

GecacitinibDRUG

(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).

Also known as: Jaktinib
Gecacitinib Hydrochloride in Combination with Rabbit Anti-human Thymocyte Immunoglobulin (ATG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    RESULT

Related Links

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Na Xu Nanfang Hospital, Southern Medical University

CONTACT

020-62787238nfyyec@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

February 27, 2026

Record last verified: 2026-02