Treatment study for patients with acute promyelocytic leukemia under 21 years of age - ICC APL Study 01

Stichting Kinderoncologie Nederland0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Patients with a clinical diagnosis of initial APL and subsequently confirmed to have PML-RARa, NPM1-RARa or NUMA-RARa fusion. Whilst this study is only for ATRA-sensitive APL, APL is a hematological emergency and ATRA should be commenced as soon as the diagnosis is suspected. Study entry should not wait until the diagnosis of APL has been confirmed molecularly or cytogenetically
•- Less than 21 years of age at initial diagnosis
•- Considered suitable for anthracycline-based chemotherapy
•- Written informed consent available
•- Females of childbearing age must have a negative pregnancy test and subsequently must attempt to avoid pregnancy

•- Patients with a clinical diagnosis of APL but subsequently found to have PLZF-RARa fusion or lacking PML-RAR*, NPM-RAR* or NuMA-RAR* rearrangement should be withdrawn from the study and treated on an alternative protocol.
•- Refractory/relapsed APL (the guidelines in this protocol for that subgroup are intended for patients treated from initial diagnosis according to this protocol)
•- Concurrent active malignancy
•- Pregnant or lactating
•- Physician and patient/guardian think that intensive chemotherapy is not an appropriate treatment option
•- Patients who have received alternative chemotherapy for 7 days or longer without ATRA for any reason (either APL not initially suspected or ATRA not available).

发起方

Stichting Kinderoncologie Nederland