coiaward2010

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)

Indication and most important 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.

Short description of intervention

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.

Type of study

Second line trial

Current status

Active, but no longer recruiting

Study sponsor

Bristol-Myers Squibb

Scientific lead / contact

Bristol-Myers Squibb

Principal investigator

...

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

Brief protocol in Kompetenznetz Leukämie 

 

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