Evaluation of the safety and efficacy of generic low-dose Dasatinib for frontline therapy in chronic phase chronic myeloid leukemia â?? A multi-center phase II single arm study (GlaD-CML Study) - GlaD-CM

Christian Medical College Vellore0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•a)Newly diagnosed Chronic phase Ph-chromosome positive chronic myeloid leukemia
•b)Diagnosed within 3 months before study entry and no previous treatment for CML except for hydroxyurea
•c)Age above 18 years
•d)Eastern Co-operative Oncology Group (ECOG) score of 2 or less
•e)Adequate hepatic and renal function (total Bilirubin level of less than 2 times the upper limit of normal, serum aspartate and alanine aminotransferase of less than 2.5 times the upper limit of normal and serum Creatinine of 3 times the upper limit of normal range)
•f)Women of reproductive age wiling to use contraception while on Dasatinib.
•g)Willing to consent for the study
•h)Available for follow up

•a)Pregnancy
•b)Breastfeeding
•c)History of congestive heart failure, Left ventricular dysfunction, myocardial infarction, pleural disease or chronic lung disease
•d)Bleeding diathesis
•e)QTc prolongation on baseline ECG (corrected QTc more than 450msec)
•f)Concomitant therapy with CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) or inducers (dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital), antacids, proton pump inhibitors and H2 antagonists
•g)Active infections
•h)Previous or concurrent cancer (other than basal-cell carcinoma skin), adequately treated stage I/II cancer and in remission or any other cancer and been disease free for 3 years.

发起方

Christian Medical College Vellore