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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT00465933
Eligibility Criteria:
Inclusion Criteria:
* Age \<= 75 years
* ECOG = 3.
* Morphological diagnosis of M3 or M3v. Those cases without typical morphology but with PML-RARa rearrangement may also be included.
* Genetic diagnosis: t(15;17), PML-RARa rearrangement, monoclonal anti-PML positive. Obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis. The presence of secondary cytogenetic changes associated with t(15;17) is not a reason for exclusion nor do they require a different therapeutic approach.
Exclusion Criteria:
* Age \> 75 years (the treatment with this protocol can be considered on an individual basis but these patients will be analysed separately)
* Absence of PML-RARa rearrangement.
* Prior antileukemic chemotherapy.
* Presence of an associated neoplasm.
* Presence of a severe psychiatric disease.
* HIV seropositivity.
* Contraindication for intensive chemotherapy, especially to anthracyclines.
* Serum creatinine = 2.5 mg/dL.
* Bilirubin, alkaline phosphatase, or SGOT \> 3 times the upper normal limit
* Positive pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT00465933
Study Brief:
Protocol Section:
NCT00465933