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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT00196768
Eligibility Criteria:
Inclusion Criteria:
* Patients in first or subsequent hematological or molecular relapse of APL
* Persistence of a positive PCR or no hematological complete remission (CR) after first line therapy
* No complete hematological remission after first line therapy
* Age over 18 years
* No upper age limit
* Informed consent of the patient
Exclusion Criteria:
* Absolute QTc-interval prolonged over 460 msec before therapy (normal electrolytes, no other drugs prolonging the QT-interval)
* Heart failure New York Health Association grade III and IV
* Renal or hepatic failure World Health Organization grade \>= III
* Pneumonia with hypoxemia
* Uncontrolled sepsis
* Pregnancy and lactation period
* Secondary malignancy, which will have major influence on the prognosis
* Expected noncompliance
* No informed consent of the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00196768
Study Brief:
Protocol Section:
NCT00196768