Gecacitinib around stem cell transplant in people with myelofibrosis and related blood cancers

Trial details

Who runs it

Ruijin Hospital

Trial code

NCT07883382

Record updated

28 October 2026

Original description

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.Read full original descriptionShow less

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

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.

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

Exclusion: Currently receiving JAK inhibitors other than gecacitinib at screening (patients who have switched from other JAK inhibitors to gecacitinib before screening are eligible); Prior allogeneic hematopoietic stem cell transplantation or organ transplantation; 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; Major surgery within 4 weeks before screening without full recovery; Treatment with anticoagulant or antiplatelet drugs (except low molecular weight heparin); Participation in other investigational drug or medical device clinical trials within 3 months before screening; Uncontrolled severe infection, shock, severe organ failure, or any other condition that would preclude tolerance of the study treatment at enrollment; Known active gastrointestinal ulcer at screening, or a history of gastrectomy or intestinal resection that may affect drug absorption; Known HIV infection and/or AIDS; History of tuberculosis infection; Epilepsy or use of psychotropic/sedative drugs at screening; Any other comorbidity that may affect the study or prior malignancy; Other severe conditions that, in the investigator's judgment, may affect patient safety or compliance; Known hypersensitivity to gecacitinib hydrochloride, drugs of the same class, or any excipients; Any comorbidity or prior malignancy that, in the investigator's judgment, may affect study participation, safety evaluation, or interpretation of study results; Any significant clinical or laboratory abnormality that may affect safety evaluation, including:; Uncontrolled diabetes (fasting blood glucose >13.9 mmol/L); Uncontrolled hypertension despite ≥2 antihypertensive drugs (SBP ≥160 mmHg or DBP ≥100 mmHg); Peripheral neuropathy (NCI-CTC AE v5.0 grade ≥2); Serum creatinine >1.5×ULN; ALT or AST >2.5×ULN; DBIL or TBIL >2.0×ULN; Pregnant or breastfeeding women; patients unable to use effective contraception throughout the study period.

ClinicalTrials.gov NCT07883382