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:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT00962767
Eligibility Criteria:
Inclusion criteria:
1. Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence of additional cytogenetic lesions is not considered an exclusion criterion) with intermediate and high risk disease.
2. Male and female patients age \> 18 years and \< 61 years.
Exclusion criteria:
1. Low risk patients (WBC \< 10 x 109/L and platelets \> 40 x 109/L).
2. Absence of PML-RAR α rearrangement in leukemic cells after successful RNA extraction and amplification of control gene.
3. Pretreated APL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
61 Years
Study:
NCT00962767
Study Brief:
Protocol Section:
NCT00962767