DASATINIB IN SUBJECTS WITH CHRONIC MYELOID LEUKEMIA OR ACUTE LYMPHOBLASTIC LEUKEMIA WITH POSITIVE PHILADELPHIA CHROMOSOME EXPERIMENTING CLINICAL BENEFITS IN CURRENT START PROTOCOLS: LONG-TERM SECURITY AND EFFECTIVENESS ANALYSIS
- Conditions
- -C921 Chronic myeloid leukaemia [CML], BCR/ABL-positiveChronic myeloid leukaemia [CML], BCR/ABL-positiveC921
- Registration Number
- PER-082-07
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 8
• Written informed consent signed
• Reference population (according to the previous START protocols) a) Patients previously treated in protocols CA180005, CA180006, CA180013, CA180015 or CA180017. b) Patients who obtained a clinical benefit with dasatinib or imatinib (study CA180017) according to the opinion of the researcher.
• Age and sex. Men and women 18 years of age or older may participate. Fertile women should be using an adequate contraceptive method to avoid pregnancy throughout the study and for a minimum period of 1 month (4 weeks) before joining and a minimum period of 3 months (12 weeks) after the last dose of the product under investigation, in such a way as to minimize the possibility of pregnancy. The term fertile woman includes any woman who has had her menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or that is not postmenopausal (defined by amenorrhea for> 12 consecutive months; or women with hormone replacement therapy [HRT] with a documented level of follicle-stimulating hormone [FSH]> 35 mIU / ml). Even women who use oral contraceptives, other hormonal contraceptives (vaginal products, skin patches or implanted or injectable products) or mechanical products such as an intrauterine device or barrier methods (diaphragms, condoms, spermicides) to prevent pregnancy or to practice abstinence or those whose partners are sterile (eg, vasectomy) will be considered fertile. Fertile women should have a negative serum or urine test for pregnancy (minimum sensitivity of 25 IU / 1 or equivalent units of HCG) within 72 hours prior to the start of the investigational product.
• Fertile women who do not wish or can not use an acceptable method to avoid pregnancy during the entire study period and for a minimum period of one month (4 weeks) before joining and a minimum period of 3 months (12 weeks) after to the last dose of study medication.
• Fertile women who use prohibited contraceptive methods (Not applicable for this study).
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test at the time of enrollment or before receiving the product under investigation.
• Sexually active fertile men whose sexual partners are fertile women who do not want or can not use an effective method to avoid pregnancy during the entire study period and for a minimum period of 3 months (12 weeks) after the conclusion of the medication of the study.
• Serious uncontrolled medical conditions or active infections capable of altering the patient´s ability to receive protocol treatment.
• Dementia or altered mental state that prevents understanding or interpreting informed consent.
• Subjects who are taking medicines generally recognized for their risk of producing torsades de pointes (torsades de pointes), including, among others: ¨ quinidine, procainamide, disopyramide ¨ amiodarone, sotalol, ibutilide, dofetilide ¨ erythromycin, larithromycin ¨ chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone ¨ cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
• halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
• Subjects taking medicinal products known to be potent inhibitors of CYP3A4 (ie, ketoconazole, ritonavir) or inducers (ie, rifampicin, efavirenz).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The quantification of BCR-ABL transcripts in peripheral blood will be evaluated using the quantitative polymerase chain reaction for reverse transcriptase (Q-RT-PCR, RT-PCR). At the month 6 visit, thereafter every 12 months and at the End of Treatment visit<br>Measure:Transcripts of BCR-ABL<br>Timepoints:month 6<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:it will be evaluated continuously and will be classified according to Version 3.0 of the NCAs CTCAE. Both safety and toxicity will be evaluated in all subjects who received any of the study medications.<br>Measure:medication toxicity<br>Timepoints:During the baseline visit, during the month 6 visit and thereafter every 12 months<br>