Exploratory study of CIGB-300 treatment in refractory or relapsing acute leukemias, elderly acute myeloid leukemia and myelodysplastic syndrome with excess blasts. - EHPMA Study

Center for Genetic Engineering and Biotechnology (CIGB).0 个研究点目标入组 10 人开始时间: 2014年11月14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) Diagnosis of refractory AL after two cycles myeloablative standard chemotherapy, AL in early relapse (within 12 months) or second relapse or post-transplantation, the elderly AML not candidates for standard induction chemotherapy (3 +7), MDS with RAEB-1 and RAEB-2.
•2) Patients no eligible for BMT at the time of inclusion.
•3) Aged =18 years.
•4) ECOG = 3.
•5) Life expectancy > 5 weeks.
•6) More than two weeks since prior therapy, including QT, or biological therapies.
•7) Patients of childbearing potential must use an effective contraceptive method.
•8) Express written request of the patient.

•1) AML promyelocytic variant (M3).
•2) Pregnancy, postpartum or breastfeeding.
•3) Any type of active infection requiring specific treatment.
•4) ALT or AST > 5 times the normal reference range.
•5) Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, ischemic heart disease or other symptomatic cardiovascular disease, epilepsy, severe mental depression).
•6) Medical history as severe allergic urticaria, atopic dermatitis, persistent bronchitis or bronchial asthma or any ingredient in the formulations studied.
•7) Obvious mental disability or other limitation that prevents the patient sign the consent or hinder study assessments.

发起方

Center for Genetic Engineering and Biotechnology (CIGB).