TREATMENT STUDY FOR CHILDREN AND ADOLESCENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA - ICC APL STUDY 01

A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA0 sites300 target enrollmentMarch 10, 2009

Overview

No summary available.

Registry

who.int

Start Date

March 10, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA

•\- Patients with a clinical diagnosis of initial APL and subsequently confirmed to have PML\-RAR\&\#945;, NPM1\-RAR\&\#945; or NUMA\-RAR\&\#945; fusion. \- Less than 21 years of age at initial diagnosis (less than 18 years for italian centers) \- 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
•Are the trial subjects under 18? yes
•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
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•\- Patients with a clinical diagnosis of APL but subsequently found to have PLZF\-RAR\&\#945; fusion or lacking PML\-RAR\&\#61537;, NPM\-RAR\&\#61537; or NuMA\-RAR\&\#61537; rearrangement should be withdrawn from the study and treated on an alternative protocol.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).