A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy ofUproleselan Administered with Chemotherapy versus Chemotherapy Alonein Patients with Relapsed/Refractory Acute Myeloid Leukemia

GlycoMimetics, Inc.0 个研究点目标入组 380 人开始时间: 2018年10月11日最近更新: 2024年8月12日

适应症

试验速览

暂无简介。

•The most important inclusion criteria are::
•=18 years and =75 years in age
•Patients with relapsed or refractory AML
•No more than one prior stem cell transplant
•Has not received the chemotherapy regimen to be used for induction on this trial
•Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial
•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 280
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•The most important exclusion criteria are:
•Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML
•Active signs or symptoms of CNS involvement by malignancy
•Stem cell transplantation =4 months prior to dosing
•Any immunotherapy or radiotherapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing
•Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing
•Inadequate organ function
•Abnormal liver function
•Known active infection with hepatitis A, B, or C, or human immunodeficiency virus
•Moderate kidney dysfunction (glomerular filtration rate <45 mL/min)
•Uncontrolled acute life-threatening bacterial, viral, or fungal infection
•Clinically significant cardiovascular disease
•Major surgery within 4 weeks of dosing

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