Phase I/II study with oral panobinostat maintenance therapy following allogeneic stem cell transplantation in patients with high risk MDS or AML (PANOBEST) - PANOBEST

Goethe Universität Frankfurt0 个研究点目标入组 62 人开始时间: 2010年8月20日最近更新: 2020年9月15日

适应症

试验速览

暂无简介。

•AML (except acute promyelocytic leukemia, AML M3) with high-risk features defined as one or more of the following criteria:
•- refractory to or relapsed after at least one cycle of standard chemotherapy
•- > 10% bone marrow blasts at day 15 of the first induction cycle
•- adverse risk cytogenetics including complex karyotype (= 3 abnormalities or abnormalities of chromosomes 3, 5 or 7) regardless of stage
•- secondary to MDS or radio-/chemotherapy
•MDS RAEB according to the WHO classification or intermediate-2 or high-risk according to IPSS
•CMML with = 5% bone marrow blasts
•Allogeneic HSCT with reduced intensity conditioning performed within 60 - 150 days prior to study entry
•Complete hematologic remission documented by bone marrow aspiration within 28 days prior to study entry
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 31
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 31

•Active acute GvHD overall grade 2 - 4
•Prior treatment with a DAC inhibitor
•Concomittant antileukemic medication
•Patients with impaired cardiac function or other concurrent severe and/or uncontrolled medical conditions
•Clinical symptoms suggesting CNS leukemia
•Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat

发起方

Goethe Universität Frankfurt