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
Complete Hematologic Response
The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
Chronic phase
The earliest phase of CML development.
Adverse event
An undesired or unintended occurrence or side effect that has a temporal relationship with the use of a medical treatment or procedure in a clinical study. An adverse event does not necessarily have a causal relationship with the study treatment.
Also called: AE
Open-label
A clinical trial in which researchers and participants know which treatment is being provided to each patient (opposite to "blinded trials" or "double-blind studies")
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Dasatinib
Trade name: Sprycel, development name: BMS-354825, inhibits BCR-ABL and SRC tyrosine kinases. Authorized for marketing in the EU since 2006 for the treatment of CML and Ph+ALL.
Other names: BMS-354825|BMS354825|Sprycel
Protocol
The action plan for the research work, which explains key objectives and procedures. In case of a clinical trial, the protocol defines e.g. the purpose of the study, how many people will participate, eligibility criteria, the medical intervention, etc.
Toxicity
The quality of being poisonous; harm resulting from drugs, e.g. side effects of chemotherapy.
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
Chronic
Long-lasting, slowly developping
CCyR
Abbreviation for Complete Cytogenetic Response, which is the absence of cells with the Philadelphia Chromosome in the bone marrow, usually detected by cytogenetics or FISH diagnostics
PCyR
Abbreviation for Partial Cytogenetic Response, meaning in the CML context that in cytogenetic tests, between 1-35% of all cells had the Philadelphia Chromosome
ECOG
Eastern Cooperative Oncology Group Index to classify the quality of life of cancer patients on a scale ranging from 0 (fully active, able to carry on all predisease activities without restriction) to 5 (death).
Also often referred to as ECOG performance status.
Gene
A unit of information present as DNA; a gene usually contains the blueprint for a protein.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
