Clinical Trail to Evaluate the Effect o… | Clinical Trial

Key information

Conditions

Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Primary Myelofibrosis

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

About this study

Previous clinical trials of Gecacitinib hydrochloride tablets in the treatment of myelofibrosis initiated by our center include: 1) ZGJAK002 trial (NCT03886415) : A multicenter phase Ⅱ clinical trial of the safety and efficacy of 100mg BID and 200mg QD of Gecacitinib in the treatment of intermediate and high risk myelofibrosis (n=118). 2) ZGJAK006 study (NCT04217993) : a phase ⅡB clinical trial of the safety and efficacy of gefitinib in Ruxolitinib intolerant myelofibrosis patients (n=51); 3) ZGJAK017 study (NCT04851535) : a phase Ⅱ trial (n=34) to evaluate the efficacy and safety of Gecacitinib in Ruxolitinib refractory or relapsed myelofibrosis patients; 4) ZGJAK016 trial (NCT04617028) : a randomized, double-blind, double-dummy, parallel-controlled, multicenter phase III trial (n=105). At present, the follow-up of the project has ended and the Gecacitinib donation phase has begun.

This study was an observational study, and about 40 patients with intermediate and high risk myelofibrosis who had participated in any previous clinical study of Gecacitinib hydrochloride and were still receiving Gecacitinib treatment in our center were expected to be enrolled. There was no additional drug intervention, only the myelofibrosis grade and gene mutation level of the patients were collected. Subjects who met all inclusion criteria and none of the exclusion criteria were eligible for inclusion in this study. After informed consent was obtained and screening was successful, bone marrow aspiration, bone marrow biopsy, and gene mutation testing were performed once. If bone marrow was extracted, peripheral blood could be used for gene mutation testing, and then annually until the permanent discontinuation of Gecacitinib.

The primary objective was to evaluate the myelofibrosis grade in patients with MF who had previously participated in a clinical study of Gecacitinib and were still receiving gefitinib. The secondary objective was to evaluate the change from baseline in JAK2 isomutations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

They had been enrolled in previous clinical trials of gefitinib for myelofibrosis (ZGJAK002, ZGJAK006, ZGJAK016 and ZGJAK017) and were still receiving gefitinib treatment.
Comply with the requirements of the ethics committee, voluntarily sign the informed consent.
Able to adhere to study and follow-up procedures.

Exclusion criteria

Patients with other serious diseases that the researcher believes may affect patient compliance and outcome observation.

Treatment and study plan

Primary outcomes

Proportion of patients with worsening/stable/improving myelofibrosis grade after treatment

Time frame: Successfully enrolled patients will undergo bone marrow biopsy as indicated by follow-up, and then once per 1 year until Gecacitinib is permanently discontinued or assessed up to 5 years, whichever came first.

Sample collection: Bone marrow biopsy tissue was at least 1.5 cm in length to ensure accuracy of bone marrow analysis. The bone marrow fibers were graded by silver staining to ensure the objectivity and reproducibility of the grading results

Secondary outcomes

The changes of JAK2 V617F, CALR and MPL W515L/K gene mutations after treatment were compared with those before treatment

Time frame: Successfully enrolled patients will undergo genetic testing as indicated by follow-up, and then once per 1 year until Gecacitinib is permanently discontinued or assessed up to 5 years, whichever came first.

Sample collection: Approximately 3-5 mL of forearm venous blood was collected to ensure adequate blood volume for molecular biological quantitative analysis

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

A Phase ⅢB Clinical Trial Evaluating the Long-term Effects of Gecacitinib Treatment on Myelofibrosis and Gene Mutation Levels in Patients Previously Enrolled in Clinical Trails of Gecacitinib for the Treatment of Myelofibrosis

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Jan 15, 2026
Registry last updated: Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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