Gecacitinib for patients with myeloid neoplasms and myelofibrosis undergoing allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a small, single-center, open-label study enrolling about 10 adults with myeloid neoplasms and bone marrow fibrosis who are planned for their first allogeneic HSCT. Participants will take gecacitinib orally starting about 13 weeks before transplant, with dose adjustments based on platelet count, and continue through the peri-transplant period for up to 24 weeks after hematopoietic reconstitution. The primary endpoint is engraftment at day +28, and secondary endpoints include graft function, acute GVHD, overall survival, infection rate, and changes in bone marrow fibrosis. The trial aims to explore safety and potential signals of efficacy in this peri-transplant window, using a single-arm design at a single center. Background evidence suggests potential benefits of JAK inhibitors as bridging therapy in MF patients and hints from preclinical work that gecacitinib may reduce GVHD and improve outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients must voluntarily sign the informed consent form, be aged ≥18 years at the time of informed consent, and may be of either sex.
2. Diagnosed with myeloid neoplasms according to 2022 WHO diagnostic criteria
3. Bone marrow fibrosis grade ≥2 according to 2016 WHO myelofibrosis grading criteria
4. Undergoing first allogeneic hematopoietic stem cell transplantation
5. ECOG performance status: 0-2
6. Able to swallow tablets
7. Able to comply with study procedures and follow-up requirements

Exclusion Criteria:

1. Currently receiving JAK inhibitors other than gecacitinib at screening (patients who have switched from other JAK inhibitors to gecacitinib before screening are eligible)
2. Prior allogeneic hematopoietic stem cell transplantation or organ transplantation
3. Uncontrolled severe infection, shock, severe organ failure, or any other condition that would preclude tolerance of the study treatment at enrollment.
4. Any significant clinical or laboratory abnormality that may affect safety evaluation, including:

   1. Uncontrolled diabetes (fasting blood glucose \>13.9 mmol/L)
   2. Uncontrolled hypertension despite ≥2 antihypertensive drugs (SBP ≥160 mmHg or DBP ≥100 mmHg)
   3. Peripheral neuropathy (NCI-CTC AE v5.0 grade ≥2)
   4. Serum creatinine \>1.5×ULN
   5. ALT or AST \>2.5×ULN; DBIL or TBIL \>2.0×ULN
5. Any of the following within 6 months before screening: NYHA class III-IV congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism; arrhythmia requiring treatment; or QTcB \>480 ms.
6. Known active gastrointestinal ulcer at screening, or a history of gastrectomy or intestinal resection that may affect drug absorption.
7. Major surgery within 4 weeks before screening without full recovery
8. Known HIV infection and/or AIDS
9. History of tuberculosis infection
10. Epilepsy or use of psychotropic/sedative drugs at screening
11. Pregnant or breastfeeding women; patients unable to use effective contraception throughout the study period
12. Any other comorbidity that may affect the study or prior malignancy
13. Treatment with anticoagulant or antiplatelet drugs (except low molecular weight heparin)
14. Other severe conditions that, in the investigator's judgment, may affect patient safety or compliance
15. Known hypersensitivity to gecacitinib hydrochloride, drugs of the same class, or any excipients
16. Participation in other investigational drug or medical device clinical trials within 3 months before screening
17. Any comorbidity or prior malignancy that, in the investigator's judgment, may affect study participation, safety evaluation, or interpretation of study results.

Where it's running

• No. 197, Ruijin Second Road, Shanghai
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Zilu Zhang, PhD
• Email: zzl12402@rjh.com.cn
• Phone: 021-64370045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• ZG005 plus gecacitinib for advanced non-small cell lung cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.