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 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT01064557
Eligibility Criteria:
Inclusion Criteria:
* Age \> 12 months (1 year) and \< 75 years
* Morphological newly diagnosis of APL
* Presence of the PML-RARa transcript
* No cardiac contraindications to anthracycline chemotherapy
* Serum creatinine \<=2.5 mg/dL
* Serum alkaline phosphatase \<= 3 times the normal upper limit
* Serum bilirubin \<= 3 times the normal upper limit
* Serum SGOT \<= 3 times the upper normal limit
* Negative pregnancy test
* Informed consent
Exclusion Criteria:
* Age \<= 12 months and \>=75 years
* absence of the PML-RARa transcript
* Pregnant of lactating women
* Presence of active serious infections that are not controlled by antibiotics
* Prior treatment with antileukemic therapy (excluded corticosteroids)
* Presence of severe concomitant psychiatric disease
* Presence of other concomitant malignant tumors, except basal cell carcinoma
* Concurrent treatment with cytotoxic chemotherapy or radiotherapy
* Cardiac contraindications to anthracycline chemotherapy
* Serum creatinine \>2.5 mg/dL
* Serum alkaline phosphatase \> 3 times the normal upper limit
* Serum bilirubin \> 3 times the normal upper limit
* Serum SGOT \> 3 times the upper normal limit
* Positive pregnancy test
* Absence of informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
75 Years
Study:
NCT01064557
Study Brief:
Protocol Section:
NCT01064557