Chronic Myeloid Leukemia in Chronic Phase MedDRA version: 14.1 Level: LLT Classification code 10054352 Term: Chronic phase chronic myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: SPRYCEL 20 mg comprimidos recubiertos
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Dasatinib Monohydrate
Other descriptive name: Dasatinib Monohydrate
Concentration unit: mg mil
Sponsors
Fundación PETHEMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Adult patients >or = 18 years 2 Diagnostic of Ph+ Chronic Myeloid Leukemia in first chronic phase 3 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 4 Patients meet criteria of late suboptimal response (complete cytogenetic response with no major molecular response) or have lost major molecular response 5 Ability to understand and voluntarily sign the informed consent form 6 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. 7 Women must not be breastfeeding. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: 1. Patients treated with Imatinib at a dose different of 400/600 mg per day 2. Patients treated with other TKI than imatinib 3. Loss of cytogenetic response at study entry 4. ECOG ? 3 5. Inadequate bone marrow reserve: ANC 2.5 X institutional upper limit of normal (IULN). Total bilirubin > 1.5 X IULN (unless Gilbert syndrome has been diagnosed) 7. Inadequate renal function (serum Cr >3 UNL or ClCr 450 msec on baseline ECG. 10. 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. 11. Patients unable or unwilling to give written, informed consent prior to study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 response after at least 18 months on Imatinib 400/600.;Secondary Objective: ? To assess the efficacy of dasatinib in terms of depth and kinetics of molecular response. ? To assess the relationship of dasatinib with the appearance of large granular lymphocytes and assess the relationship of LGL with efficacy and toxicity. ? PFS;Primary end point(s): The primary efficacy endpoint is the Major molecular response rate at 6 months of dasatinib treatment.;Timepoint(s) of evaluation of this end point: At 6 months of dasatinib treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints include Major molecular response rate at 12 months, Complete molecular response rate at 6 and 12 moths, Incidence of lymphocytosis, Major and complete molecular response rates in patients with and without lymphocytosis and PFS.;Timepoint(s) of evaluation of this end point: At 6 and 12 months of dasatinib treatment. | — |
Countries
Spain
Contacts
Public ContactLiana de Plasencia
Dynamic
Outcome results
None listed