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RECRUITING

NCT07883382

PHASE1/PHASE2

An Exploratory Study on the Use of Gecacitinib in Patients With Myeloid Malignancies and Myelofibrosis During the Peri-transplant Period Following Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

This is a single-arm, single-center exploratory study evaluating the safety and efficacy of gecacitinib administered in the peri-transplant period in patients with myeloid neoplasms and myelofibrosis (MF) who are scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).Approximately 10 eligible patients will receive oral gecacitinib starting 13 weeks before transplantation. Treatment will continue through the peri-transplant period and for up to 24 weeks after hematopoietic reconstitution. The primary endpoint is the engraftment rate at day +28 post-transplant. Secondary endpoints include poor graft function rate, grade III-IV acute GVHD rate, overall survival, infection rate, and bone marrow fibrosis grade changes.

Official title: An Exploratory Study of Gecacitinib in the Peri-Transplant Period for Patients With Myeloid Neoplasms and Myelofibrosis Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-15

Completion Date

2029-09-30

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Myeloid Neoplasms With Myelofibrosis

Interventions

DRUG

gecacitinib Hydrochloride Tablets

gecacitinib is administered orally, starting 13 weeks before allo-HSCT. Starting dose is based on baseline platelet count: 100 mg twice daily (BID) if platelets ≥50×10\^9/L, or 50 mg BID if platelets \<50×10\^9/L.The dose will be reduced to 50 mg BID beginning on day -7 (1 week before transplantation) and maintained at this dose during conditioning and transplantation. After hematopoietic reconstitution (PLT ≥50×10\^9/L and ANC ≥0.5×10\^9/L), the dose is increased to 100 mg BID for 12 weeks, then tapered to 50 mg BID for another 12 weeks before discontinuation. Dose adjustments are made based on adverse events and hematologic parameters, with a maximum dose of 100 mg BID and minimum of 50 mg once daily (QD).

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.

Locations (1)

No. 197, Ruijin Second Road, Shanghai

Shanghai, China