Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT01226303
Eligibility Criteria:
Inclusion Criteria:
* Patients with a clinical diagnosis of initial APL and subsequently confirmed to have PML-RARα, NPM1-RARα or NUMA-RARα 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 (for AIEOP, see appendix A)
* 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
Exclusion Criteria:
* Patients with a clinical diagnosis of APL but subsequently found to have PLZF-RARα fusion or lacking PML-RARα, NPM-RARα or NuMA-RARα rearrangement should be withdrawn from the study and treated on an alternative protocol.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).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT01226303
Study Brief:
Protocol Section:
NCT01226303