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Die klinische Studie NCT07342712 für Myelofibrose ist aktiv, nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Clinical Trail to Evaluate the Effect of Long-term Treatment With Gecacitinib on Myelofibrosis and Gene Mutation Levels 40 Beobachtend

Aktiv, nicht rekrutierend
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Die klinische Studie NCT07342712 ist eine beobachtungsstudie zur Untersuchung von Myelofibrose und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 1. August 2025 und soll 40 Teilnehmer aufnehmen. Durchgeführt von First Affiliated Hospital of Zhejiang University ist der Abschluss für 7. Dezember 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 15. Januar 2026 aktualisiert.
Kurzbeschreibung
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 ...Mehr anzeigen
Ausführliche Beschreibung
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 effi...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
Myelofibrose
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • IIT20250082B-R2
NCT-Nummer
NCT07342712
Studienbeginn (tatsächlich)
2025-08-01
Zuletzt aktualisiert
2026-01-15
Studienende (vorauss.)
2027-12-07
Geplante Rekrutierung
40
Studientyp
Beobachtungsstudie
Status
Aktiv, nicht rekrutierend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Proportion of patients with worsening/stable/improving myelofibrosis grade after treatment
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
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.
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
The changes of JAK2 V617F, CALR and MPL W515L/K gene mutations after treatment were compared with those before treatment
Sample collection: Approximately 3-5 mL of forearm venous blood was collected to ensure adequate blood volume for molecular biological quantitative analysis
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.
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Zugelassene Geschlechter
Alle
  • 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.

  • Patients with other serious diseases that the researcher believes may affect patient compliance and outcome observation.
First Affiliated Hospital of Zhejiang University logoFirst Affiliated Hospital of Zhejiang University
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1 Studienstandorte in 1 Ländern

Zhejiang

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China