Phase
Condition
Leukemia
Treatment
dasatinib (SPRYCEL®)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Ph+chromosome [t(9;22)(q34;q11)].
- Ph negative cases or patients with variant translocations who are BCR-ABL positive inmultiplex PCR4 will be also considered eligible.
- ECOG performance status ≤2.
- Age ≥ 18 years old (no upper age limit is given)
- Serum levels of potassium, magnesium and total calcium within the normal limits (≥LLN [lower limit of normal] and ≤ULN [upper limit of normal]). Correction of electrolytes'levels with supplements to meet enrolment criteria is allowed.
- AST and ALT ≤2.5 x ULN or 5.0 x ULN if considered due to leukemia
- Alkaline phosphatase ≤2.5 x ULN unless considered due to leukemia
- Total bilirubin ≤1.5 x ULN, except known Gilbert disease
- Serum creatinine ≤2 x ULN
- Written informed consent prior to any study procedures being performed. For 1st-line patients:
• Pre-treatment with hydroxyurea up to 6 months and imatinib or dasatinib for duration ofup to 4 weeks is permitted. For ≥ 2nd-line patients:
• Patients with treatment failure according to the 2013 ELN Recommendations criteria3 ortreatment intolerance as assessed by the investigator after prior treatment with TKIs otherthan dasatinib (imatinib, nilotinib, bosutinib, ponatinib).
Exclusion
Exclusion Criteria:
- Previous allogeneic stem cell transplantation (AlloSCT)
- Known impaired cardiac function, including any of the following:
- Congenital long QT syndrome
- History of or presence of clinically significant ventricular or atrialtachyarrhythmia
- QTc >450 msec on screening ECG
- Myocardial infarction within 6 months prior to starting therapy
- Other clinical significant heart disease (e.g. unstable angina pectoris, congestiveheart failure)
- Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores >6), even if controlled
- Other concurrent uncontrolled medical conditions (e.g., active or uncontrolledinfections, acute or chronic liver and renal disease) that could cause unacceptablesafety risks or compromise compliance with the protocol
- Impaired gastrointestinal function or disease that may alter the absorption of studydrug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea,malabsorption syndrome, small bowel resection or gastric by-pass surgery)
- Concomitant medications known to be strong inducers or inhibitors of the CYP450isoenzyme CYP3A4
- Patients who have undergone major surgery ≤2 weeks prior to starting study drug or whohave not recovered from side effects of such therapy
- Patients who are pregnant or breastfeeding or women of reproductive potential notemploying an effective method of birth control. Women of childbearing potential musthave a negative serum pregnancy test within 14 days prior to administration ofdasatinib. Post-menopausal women must be amenorrheic for at least 12 months in orderto be considered of non-childbearing potential. Male and female patients must agree toemploy an effective method of birth control throughout the study and for up to 3months following discontinuation of study drug
- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is notmandatory)
- Active autoimmune disorder, including autoimmune hepatitis
- Known serious hypersensitivity reactions to dasatinib
- Patients with a history of another primary malignancy that is currently clinicallysignificant or currently requires active intervention
- Patients unwilling or unable to comply with the protocol.
Study Design
Study Description
Connect with a study center
Uniklinik der RWTH Aachen
Aachen, 52074
GermanySite Not Available
Gesundheitszentrum St. Marien GmbH
Amberg, 92224
GermanySite Not Available
Gemeinschaftspraxis Dres. Klausmann
Aschaffenburg, 63739
GermanySite Not Available
OnkoBer
Berlin, 10115
GermanySite Not Available
Evangelisches Klinikum Bethel gGmbH
Bielefeld, 33611
GermanySite Not Available
Universitätsklinikum Bonn
Bonn, 53111
GermanySite Not Available
Klinikum Bremen-Mitte gGmbH
Bremen, 28177
GermanySite Not Available
Klinikum Chemnitz gGmbH
Chemnitz, 09113
GermanySite Not Available
Gemeinschaftspraxis Mohm/Prange-Krex
Dresden, 01307
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, 01307
GermanySite Not Available
Helios St. Johannes Klinik Duisburg
Duisburg, 47166
GermanySite Not Available
Gemeinschaftspraxis Erlangen
Erlangen, 91052
GermanySite Not Available
Universitätsklinikum Essen
Essen, 45147
GermanySite Not Available
Universitätsklinikum Frankfurt
Frankfurt, 60590
GermanySite Not Available
Universitätsklinikum Freiburg
Freiburg, 79106
GermanySite Not Available
Katholisches Karl-Leisner Klinikum
Goch, 47574
GermanySite Not Available
MVZ Onkologische Kooperation Harz
Goslar, 38642
GermanySite Not Available
ConMed GmbH
Göttingen, 37073
GermanySite Not Available
Hämato-Onkologische Gemeinschaftspraxis Halberstadt
Halberstadt, 38820
GermanySite Not Available
Universitätsklinikum Halle/S.
Halle, 06120
GermanySite Not Available
Asklepios MVZ Onkologie
Hamburg, 22417
GermanySite Not Available
MediProjekt GbR
Hannover, 30171
GermanySite Not Available
St. Bernward Krankenhaus Hildesheim
Hildesheim, 31134
GermanySite Not Available
Universitätsklinikum Jena
Jena, 07740
GermanySite Not Available
Institut für med. Dokumentation, Gutachtenstellung, Gesundheitsförderung und Qualitätssicherung GbR
Kaiserslautern, 67655
GermanySite Not Available
St. Vincentius-Kliniken Karlsruhe
Karlsruhe, 76137
GermanySite Not Available
Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe, 76133
GermanySite Not Available
Klinikum Kassel
Kassel, 34125
GermanySite Not Available
Onkologische Gemeinschaftspraxis
Kassel, 34119
GermanySite Not Available
Städtisches Krankenhaus Kiel GmbH
Kiel, 24116
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein
Kiel, 24116
GermanySite Not Available
InVo Institut für Versorgungsforschung
Koblenz, 56068
GermanySite Not Available
MVZ Hämatologie und Onkologie
Krefeld, 47805
GermanySite Not Available
Onkologische Schwerpunktpraxis
Kronach, 96317
GermanySite Not Available
Onkologisches Zentrum
Lebach,
GermanySite Not Available
Studienzentrum UnterEms
Leer, 26789
GermanySite Not Available
Universitätsklinikum Leipzig
Leipzig, 04103
GermanySite Not Available
Universitätsmedizin Mannheim
Mannheim, 68169
GermanySite Not Available
Universitätsklinikum Gießen und Marburg GmbH
Marburg, 35043
GermanySite Not Available
Stauferklinikum Schwäbisch Gmünd
Mutlangen, 73557
GermanySite Not Available
Gemeinschaftspraxis Hämatologie/ Onkologie
München, 81241
GermanySite Not Available
Rotkreuzklinikum München
München, 80634
GermanySite Not Available
Universitätsklinikum Münster
Münster, 48149
GermanySite Not Available
Hämatologisch-onkologische Schwerpunktpraxis
Neustadt Am Rübenberge, 31535
GermanySite Not Available
Klinikum Passau
Passau, 94032
GermanySite Not Available
Kreiskliniken Reutlingen GmbH
Reutlingen, 72764
GermanySite Not Available
Klinikum Südstadt Rostock
Rostock, 18059
GermanySite Not Available
Universitätsmedizin Rostock
Rostock, 18057
GermanySite Not Available
Hämatologie-Onkologie Stolberg
Stolberg, 52222
GermanySite Not Available
Klinikum Mutterhaus der
Trier, 54290
GermanySite Not Available
Universitätsklinikum Ulm
Ulm, 89081
GermanySite Not Available
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, 78052
GermanySite Not Available
Rems-Murr-Klinik Winnenden
Winnenden, 71364
GermanySite Not Available
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