se of Alpha Interferon in the treatment of Chronic Myeloid Leukaemia.

Center for Genetic Engineering and Biothecnology (CIGB), in Havana.0 个研究点目标入组 60 人开始时间: 2009年12月24日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1.Informed consent given by the patient. 2.Diagnosis of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase/or a positive RT-PCR analysis for the BCR-ABL gene fusion. 3.Pacients from both sexes, must be eighteen years of age or older. 4.Patients who haven’t previously been treated with interferon alfa. 5.Obtain a clinical-haematological remission during the treatment with chemotherapy.

•1.Pregnant or lactating women. 2.Fertile age women that are under hormone anti-conceptive therapy or that they haven’t control of their fertility. 3.A history of hypersensitivity to interferon or any excipient in the study treatment 4.Patients with accelerated phase or blastic crisis. 5.Extramedular blastic crisis. 6.Acute or chronic hepatic disease (AST and ALT > 2 times upper limit of normal and/or serum total bilirubin >17 micromol/L). 7.Renal failure. 8.Cardiac failure and/or decompensated arterial hypertension. 9.Mental impairment that may compromise the ability to give informed consent and comply with the study requirements.

发起方

Center for Genetic Engineering and Biothecnology (CIGB), in Havana.