A phase Ib/II clinical evaluation of the safety and tolerability of maintenance 5-Azacitidine combined with Lenalidomide in patients complete remission after cytoreductive chemotherapy for acute myeloid leukaemia (AML).

Andrew Wei0 个研究点目标入组 30 人开始时间: 2011年2月1日最近更新: 2020年1月13日

试验速览

暂无简介。

•Acute Myeloid Leukaemia (AML) patients in complete remission (CR) or complete remission with incomplete count recovery (CRi).
•-Life expectancy greater than 3 months.
•-Eastern cooperative oncology group (ECOG) status 0-3
•-Blood electrolytes level within normal limits.
•-Adequate renal functions.
•-Adequate hepatic functions
•-No uncontrolled active infection.
•-Women of child bearing age must have a negative pregnancy test prior to start of study therapy, and she must agree to ongoing pregnancy tests.
•-Male subjects must agree to use protection during sexual contact with a woman of child bearing potential. They must also agree not to donate semen during study drug therapy and for a period after study drug therapy.

•-Any serious medical or psychiatric conditions.
•-History of major non-compliance to medication.
•-Evidence of Central Nervous System (CNS) leukemia.
•-Uncontrolled viral infection with known Human Immunodeficiency Virus (HIV) or Hepatitis type B or C.
•-Previous failure of response to azacitidine therapy.
•-Currently active gastrointestinal disease.
•-Any other concurrent severe and/or oncontrolled medical conditions.
•-Female patients who are pregnant or breastfeeding and the lack of adequate contraception in females.

发起方

Andrew Wei