Midostaurin + Gemtuzumab Ozogamicin combination in first-line standard therapy for acute myeloid leukemia - MOSAIC

Technische Universität Dresden0 个研究点目标入组 214 人开始时间: 2019年11月28日最近更新: 2024年6月18日

试验速览

暂无简介。

•- Written informed consent
•- Newly diagnosed AML according to WHO criteria plus the following molecular or cytogenetic specifications:
•o Phase I (Dose escalation):
•t(8;21)/RUNX1-RUNX1T1 or
•inv(16) or t(16;16)/CBFB-MYH11 or
•FLT3-ITD or
•o Phase II (MAGNOLIA) Expansion in CBF AML
•t(8;21)/RUNX1-RUNX1T1 or
•inv(16) or t(16;16)/CBFB-MYH11,
•o Phase II (MAGMA) Expansion in FLT3mut AML
•FLT3-ITD or
•Absence of mutations in the core-binding factor genes (i.e. t(8;21)/RUNX1-RUNX1T1 or inv(16) or t(16;16)/CBFB-MYH11)
•- Male and female patients with age
•18-70 years
•- ECOG 0-2,
•- Life expectancy > 14 days,
•- Adequate hepatic and renal function
•ALAT/ASAT = 2.5 x ULN
•Bilirubin < 2 x ULN
•Creatinin < 1.5 x ULN or Creatinine clearance > 40 ml/min,
•- White blood cell count < 30 × 10^9/L. Note: Hydroxyurea and/or a dose of 100-200 mg/m^2 cytarabine per day for up to 3 days (for emergency use
•for clinical stabilization) is permitted to meet this criterion.
•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 214
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 214

•- Previous antineoplastic treatment for AML other than hydroxyurea and/or cytarabine for emergency use (100-200 mg/m^2 per day on maximal 3 days),
•- Previous treatment with anthracyclines,
•- CNS involvement,
•- Uncontrolled infection,
•- Strong CYP3A4/5 enzyme inducing drugs unless they can be discontinued or replaced prior to enrollment.

发起方