DEVELOPMENT SAFETY UPDATE REPORT HALF DSUR č. 3

DEMLOVÁ, Regina and Adéla BÁRTOVÁ. DEVELOPMENT SAFETY UPDATE REPORT HALF DSUR č. 3 (DEVELOPMENT SAFETY UPDATE REPORT HALF DSUR No. 3). NA. Brno: MU LF/MŠMT/FN BRNO, 2023, 20 pp. NA.

Basic information

• Original name: DEVELOPMENT SAFETY UPDATE REPORT HALF DSUR č. 3
• Name in Czech: DEVELOPMENT SAFETY UPDATE REPORT HALF DSUR č. 3
• Name (in English): DEVELOPMENT SAFETY UPDATE REPORT HALF DSUR No. 3
• Authors: DEMLOVÁ, Regina (203 Czech Republic, guarantor) and Adéla BÁRTOVÁ (203 Czech Republic, belonging to the institution).
• Edition: NA. Brno, 20 pp. NA, 2023.
• Publisher: MU LF/MŠMT/FN BRNO

Other information

• Original language: Czech
• Type of outcome: Research report
• Field of Study: 30230 Other clinical medicine subjects
• Country of publisher: Czech Republic
• Confidentiality degree: is not subject to a state or trade secret
• WWW: HALF
• RIV identification code: RIV/00216224:14110/23:00131971
• Organization unit: Faculty of Medicine
• Keywords (in Czech): inhibitor tyrozinkinázy; HHALF; CZECRIN; klinická studie;chronická myeloidní leukemie
• Keywords in English: tyrosine kinase inhibitor; HHALF; CZECRIN; clinical study; chronic myeloid leukemia
• Tags: FN Brno, interim report, MU

Abstract

Prospektivní klinická studie fáze II hodnotící v celonárodním měřítku efektivitu a bezpečnost vysazování inhibitorů tyrozinkinázy po předchozí dvoustupňové redukci dávky u pacientů s chronickou myeloidní leukemií v hluboké molekulární remisi. Třetí periodická zpráva ke studii HALF hodnotí bezpečnostní data obdržená zadavatelem studie během období 16.6.2022 až 15.6.2023. Klinické hodnocení probíhá v ČR momentálně v osmi centrech.

Abstract (in English)

A prospective clinical phase II evaluation study on a nationwide scale, the effectiveness and safety of discontinuation of tyrosine kinase inhibitors after a previous two-step dose reduction in patients with chronic myeloid leukemia in deep molecular remission. The third periodic report on the HALF study evaluates the safety data received by the sponsor of the study during the period 6/16/2022 to 6/15/2023. Clinical evaluation is currently taking place in eight centers in the Czech Republic.

Links

• 90249, large research infrastructures: Name: CZECRIN IV