Status:
UNKNOWN
Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase
Lead Sponsor:
PETHEMA Foundation
Collaborating Sponsors:
Dynamic Solutions
Bristol-Myers Squibb
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular resp...
Detailed Description
This is a single-arm, open-label, phase II trial for patients in complete cytogenetic response that have not achieved major molecular response or have lost a prior major molecular response, after at l...
Eligibility Criteria
Inclusion
- Adult patients \>or = 18 years
- Diagnostic of Ph+ Chronic Myeloid Leukemia in first chronic phase
- Treated with Imatinib 400 mg per day or 600 mg per day for at least 18 months. A wash out period of at least 7 days for imatinib is required prior to dasatinib administration
- Patients meet criteria of late suboptimal response (complete cytogenetic response with no major molecular response) or have lost major molecular response
- Ability to understand and voluntarily sign the informed consent for
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy and have a negative pregnancy test, a maximum of 72 hours prior to study drug start.
- Sexually active men must also use effective contraceptive methods during the treatment.
- Women must not be breastfeeding
Exclusion
- Patients treated with Imatinib at a dose different of 400/600 mg per day
- Patients treated with other TKI than imatinib
- Loss of cytogenetic response at study entry
- ECOG ≥ 3
- Inadequate bone marrow reserve: ANC \<1.5 x 109/L and/or Platelet count \< 100 x 109/L
- Inadequate hepatic function (Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)\> 2.5 X institutional upper limit of normal (IULN). Total bilirubin \> 1.5 X IULN (unless Gilbert syndrome has been diagnosed)
- Inadequate renal function (serum Cr \>3 UNL or ClCr \<45 ml/min)
- Patients receiving concurrent treatment with other experimental drugs or anti-cancer therapy
- Patients with uncontrolled concurrent disease:
- Known pleural effusion at baseline Clinically-significant gastrointestinal disease or surgery that would compromise absorption of study drug (eg, uncontrolled nausea or malabsorption syndrome) Clinically-significant known coagulation or platelet function disorder (not related to thrombocytopenia), eg, von Willebrand's disease Other active malignancy requiring concurrent intervention
- Uncontrolled or significant cardiovascular disease, including any of the following:
- Myocardial infarction within 6 months of enrolment date Uncontrolled angina or congestive heart failure within 3 months of enrolment date Left ventricular ejection fraction (LVEF) \< 40% Significant cardiac conduction abnormality, including history of clinically-significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), history of third degree heart block or diagnosed congenital long QT syndrome, and/or prolonged QTc/f interval \> 450 msec on baseline ECG.
- Patients with active or uncontrolled infections or with serious illnesses or medical conditions that would not permit the patient to be managed according to the protocol.
- Patients unable or unwilling to give written, informed consent prior to study participation.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01802450
Start Date
March 1 2013
End Date
December 1 2016
Last Update
September 17 2015
Active Locations (15)
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1
Hospital Txagorritxu
Vitoria-Gasteiz, Alava, Spain, 01010
2
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
3
Institut Catalá d'Oncologia L'Hospitallet
Barcelona, Barcelona, Spain, 08907
4
Complejo Hospitalario de Toledo - Hospital Virgen de la Salud
Toledo, Castille-La Mancha, Spain, 45004