Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naïve disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase Inhibitors (≥2nd line) (DasaHIT Trial (Dasatinib Holiday for Improved Tolerability))
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02890784 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University of Jena |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Andreas Hochhaus, Prof. |
Principal Investigator Affiliation | Jena University Hospital |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Germany |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Myeloid Leukemia, Chronic |
Dasatinib is indicated in Europe for:
Active Comparator: A. Standard arm
100mg dasatinib (SPRYCEL®) daily dose (QD) (7x100) (Standard therapy)
Experimental: B. Study arm
100mg dasatinib (SPRYCEL®) (QD) weekdays (1-5) only (5x100+2x0) (overall dose reduction per week)
Drug: - dasatinib (SPRYCEL®)
Treatment optimization for patients with chronic myeloid leukemia (CML)
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Uniklinik der RWTH Aachen
Aachen, , 52074
Status
Recruiting
Address
Gesundheitszentrum St. Marien GmbH
Amberg, , 92224
Status
Recruiting
Address
Gemeinschaftspraxis Dres. Klausmann
Aschaffenburg, , 63739
Status
Recruiting
Address
OnkoBer
Berlin, , 10115
Status
Recruiting
Address
Evangelisches Klinikum Bethel gGmbH
Bielefeld, , 33611
Status
Recruiting
Address
Universitätsklinikum Bonn
Bonn, , 53111
Status
Recruiting
Address
Klinikum Bremen-Mitte gGmbH
Bremen, , 28177
Status
Recruiting
Address
Klinikum Chemnitz gGmbH
Chemnitz, , 09113
Status
Recruiting
Address
Gemeinschaftspraxis Mohm/Prange-Krex
Dresden, , 01307
Status
Recruiting
Address
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, , 01307
Status
Recruiting
Address
Helios St. Johannes Klinik Duisburg
Duisburg, , 47166
Status
Recruiting
Address
Gemeinschaftspraxis Erlangen
Erlangen, , 91052
Status
Recruiting
Address
Universitätsklinikum Essen
Essen, , 45147
Status
Recruiting
Address
Universitätsklinikum Frankfurt
Frankfurt, , 60590
Status
Recruiting
Address
Universitätsklinikum Freiburg
Freiburg, , 79106
Status
Recruiting
Address
Katholisches Karl-Leisner Klinikum
Goch, , 47574
Status
Recruiting
Address
MVZ Onkologische Kooperation Harz
Goslar, , 38642
Status
Recruiting
Address
ConMed GmbH
Göttingen, , 37073
Status
Recruiting
Address
Hämato-Onkologische Gemeinschaftspraxis Halberstadt
Halberstadt, , 38820
Status
Recruiting
Address
Universitätsklinikum Halle/S.
Halle, , 06120
Status
Recruiting
Address
Asklepios MVZ Onkologie
Hamburg, , 22417
Status
Recruiting
Address
MediProjekt GbR
Hannover, , 30171
Status
Recruiting
Address
St. Bernward Krankenhaus Hildesheim
Hildesheim, , 31134
Status
Recruiting
Address
Universitätsklinikum Jena
Jena, , 07740
Status
Recruiting
Address
Institut für med. Dokumentation, Gutachtenstellung, Gesundheitsförderung und Qualitätssicherung GbR
Kaiserslautern, , 67655
Status
Recruiting
Address
Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe, , 76133
Status
Recruiting
Address
St. Vincentius-Kliniken Karlsruhe
Karlsruhe, , 76137
Status
Recruiting
Address
Onkologische Gemeinschaftspraxis
Kassel, , 34119
Status
Recruiting
Address
Klinikum Kassel
Kassel, , 34125
Status
Recruiting
Address
Städtisches Krankenhaus Kiel GmbH
Kiel, , 24116
Status
Recruiting
Address
Universitätsklinikum Schleswig-Holstein
Kiel, , 24116
Status
Recruiting
Address
InVo Institut für Versorgungsforschung
Koblenz, , 56068
Status
Recruiting
Address
MVZ Hämatologie und Onkologie
Krefeld, , 47805
Status
Recruiting
Address
Onkologische Schwerpunktpraxis
Kronach, , 96317
Status
Recruiting
Address
Onkologisches Zentrum
Lebach, ,
Status
Recruiting
Address
Studienzentrum UnterEms
Leer, , 26789
Status
Recruiting
Address
Universitätsklinikum Leipzig
Leipzig, , 04103
Status
Recruiting
Address
Universitätsmedizin Mannheim
Mannheim, , 68169
Status
Recruiting
Address
Universitätsklinikum Gießen und Marburg GmbH
Marburg, , 35043
Status
Recruiting
Address
Stauferklinikum Schwäbisch Gmünd
Mutlangen, , 73557
Status
Recruiting
Address
Rotkreuzklinikum München
München, , 80634
Status
Recruiting
Address
Gemeinschaftspraxis Hämatologie/ Onkologie
München, , 81241
Status
Recruiting
Address
Universitätsklinikum Münster
Münster, , 48149
Status
Recruiting
Address
Hämatologisch-onkologische Schwerpunktpraxis
Neustadt Am Rübenberge, , 31535
Status
Recruiting
Address
Klinikum Passau
Passau, , 94032
Status
Recruiting
Address
Kreiskliniken Reutlingen GmbH
Reutlingen, , 72764
Status
Recruiting
Address
Universitätsmedizin Rostock
Rostock, , 18057
Status
Recruiting
Address
Klinikum Südstadt Rostock
Rostock, , 18059
Status
Recruiting
Address
Hämatologie-Onkologie Stolberg
Stolberg, , 52222
Status
Recruiting
Address
Klinikum Mutterhaus der
Trier, , 54290
Status
Recruiting
Address
Universitätsklinikum Ulm
Ulm, , 89081
Status
Recruiting
Address
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, , 78052
Status
Recruiting
Address
Rems-Murr-Klinik Winnenden
Winnenden, , 71364