DASPERSE = Dasatinib in chronic phase myeloid leukemia patients with chronic toxicity to imatinib
Study title
Dasatinib in chronic phase myeloid leukemia patients with chronic toxicity to imatinib [Asia, Europe, USA]
Scientific title
A Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib (EudraCT 2011-006180-21, ClinicalTrials.gov NCT01660906)
Type of study
Second line trial
Current status
Active, but no longer recruiting
What is the purpose of the study
This study will assess the frequency of reduction or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic adverse events at 3 months after switch to dasatinib.
Key inclusion criteria
Potential study participants must be 18 years or older with CP CML achieving an optimal response (either complete hematologic response (CHR) by 3 months, partial cytogenetic response (PCyR) by 6 months, or complete cytogenetic response (CCyR) by 12 months) to imatinib treatment. They are currently experiencing at least one imatinib-related Grade 1 or 2 non-hematologic adverse events persisting for at least 2 months or recurring at least 3 times in the preceding 12 months, despite best supportive care.
To be enrolled in this study, patients must have a daily ECOG performance status not higher than 2 and a life expectancy of more 6 than months. Kidney and liver function should be adequate.
Key exclusion criteria
Where can I find additional information
Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)
Study description in the US register ClinicalTrials.gov, a service of the U.S. National Institutes of Health
Study sponsor
Bristol-Myers Squibb
Scientific lead / contact
Bristol-Myers Squibb
Principal investigator
…
Study centers / principal investigators
France
Creteil Cedex, 94010
Lille Cedex, 59037
Pierre Benite cedex, 69495
Pringy Cedex, 74374
Vandoeuvre les Nancy, 54511
Germany
Jena
Universitätsklinikum Jena
Klinik und Poliklinik für Innere Medizin II
Prof. Dr. med. Andreas Hochhaus
Köln, 50937
Lübeck, 23562
Mannheim, 68169
Rostock, 18055
Italy
Catania, 95124
Firenze, 50134
Roma, 00144
Roma, 00161
Torino, 10126
Korea, Republic of
Seoul, 137-701
United States
Pacific Cancer Medical Center
Anaheim, California, 92801
Ajit Maniam
Cancer Center of Central Connecticut
Southington, Connecticut, 06489
St. Agnes Healthcare, Inc
Baltimore, Maryland, 21229
Peter Byeff
Promedica Hematology & Oncology Assoicates
Sylvania, Ohio, 43560
William R. Horvath
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jorge E. Cortes