Clinical trial • Oncology

azacitidine for Myelodysplastic syndromes | Chronic myelomonocytic leukemia

Clinical trial of azacitidine for Myelodysplastic syndromes | Chronic myelomonocytic leukemia. 42 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Myelodysplastic syndromes | Chronic myelomonocytic leukemia
Drug Modality
Small molecule | Small molecule

Key dates

Initial CTIS Submission Date
30-01-2025
First CTIS Authorization Date
29-04-2025

Trial design

Clinical trial across 10 sites in Germany.

Target Sample Size
42

Recruitment

Planned Sample Size
42
Recruitment Window Months
38

Geography

Total Number Of Sites
10
Total Number Of Participants
42

Germany

Earliest CTIS Part Ii Submission Date
16-04-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
377
Number Of Sites
10
Number Of Participants
42

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Medizinische Klinik und Poliklinik: Hämatologie und Medizinische Onkologie
Contact Person Name
Daniel Sasca
Site Name
Heidelberg University
Department Name
Medizinische Klinik für Hämatologie und Internistische Onkologie
Contact Person Name
Susanne Saußele
Contact Person Email
irina.manzano@umm.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Hämatologie und Medizinische Onkologie
Contact Person Name
Hannes Treiber
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Friederike Wortmann
Contact Person Email
Friederike.Wortmann@uksh.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik III
Contact Person Name
Karin Mayer
Contact Person Email
karin.mayer@ukbonn.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik und Poliklinik für Innere Medizin III
Contact Person Name
Anna Hecht-So
Contact Person Email
anna.hecht@mri.tum.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Hämatologie, Onkologie und Klinische Immunologie
Contact Person Name
Ulrich Germing
Contact Person Email
germing@med.uni-duesseldorf.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik I, Early Clinical Trial Unit
Contact Person Name
Katja Sockel
Contact Person Email
Katja.Sockel@ukdd.de
Site Name
Medizinische Hochschule Hannover
Department Name
Abteilung für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Contact Person Name
Felicitas Thol
Contact Person Email
thol.felicitas@mh-hannover.de
Site Name
Klinikum Oldenburg AöR
Department Name
Onkologie/Hämatologie
Contact Person Name
Cyrus Khandanpour

Sponsor

Primary sponsor

Full Name
Heidelberg University
Organisation Type
Educational Institution
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
PXS-5505
Modality
Small molecule
Investigational Product Name
5-Azacitidine
Active Substance
azacitidine
Modality
Small molecule
Combination Treatment
Yes

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