A Phase Ib study of Vyxeos® (liposomal daunorubicin and cytarabine) in combination with Clofarabine in children with relapsed/refractory AML - SP_MH20VYX

Prinses Maxima Centrum voor Kinderoncologie B.V.0 个研究点目标入组 25 人开始时间: 2023年12月21日最近更新: 2024年7月22日

研究概览

暂无简介。

•Any = 2nd relapse of AML • Refractory AML (defined as = 20% blasts in the bone marrow after standard (re-) induction therapy) • Early 1st relapse (defined as relapse within one year from initial diagnosis) of AML • Any relapse of AML after prior allogenic HSCT • Any relapse of AML with high risk cytogenetic characteristics • Complete initial work-up within 7 days prior to study entry, including bone-marrow aspiration, lumbar puncture (without intrathecal therapy) • Lansky play score = 60 for patients <16 years of age; or Karnofsky performance status = 60 for patients = 16 years of age • Life expectancy > 6 weeks • a calculated GFR = 70mL/min/1.73 m2 • Liver function: total serum bilirubin = 3 mg/dl or 50 µmol/L and aspartate transaminase (AST) and alanine transaminase (ALT) =200 U/L • Adequate cardiac function (defined as shortening fraction =28% or ejection fraction =50%)

•evidence of a currently uncontrolled bacterial, viral or parasitic infection • evidence of a fungal infection, defined as either: - Pulmonary infiltrates suggestive of a fungal infection at HR-CT (within 3 weeks prior to enrollment) - Positive Aspergillus serum test (galactomannan), according to local laboratory practice (within 3 weeks prior to enrollment) • evidence of isolated extramedullary relapse, including isolated CNS-relapse • evidence of CNS3 or symptomatic CNS leukemia • Down Syndrome • evidence of relapsed/refractory acute promyelocytic leukemia (APL) • use of any anticancer therapy within 2 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy (note: hematological toxicities do not need to be considered since the patient has overt leukemia) • history of prior veno-occlusive disease (VOD) • known hypersensitivity to cytarabine, clofarabine or liposomal daunorubicin • known copper metabolism deficiency, such as Wilson's disease.

发起方

Prinses Maxima Centrum voor Kinderoncologie B.V.