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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04870060
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients 18 years and above .
2. Patients who give written informed consent
3. Patients with performance status - 0,1 or 2(ECOG scale)
4. Patients receiving any of the following high dose chemotherapy regimens
1. Melphalan- 200 mg/m2 or more (MEL-200 mg/m2)
2. Busulfan and Melphalan (BuMEL)
3. Carmustine (BCNU), Etoposide, Cytosine Arabinoside and Melphalan ( BEAM)
5. Patients who have creatinine clearance \> 50 ml/min
6. Patients with serum bilirubin levels \< 2mg/dl. and serum liver enzymes (ALT or AST or both) greater than 5 times the upper limit of normal value.
Exclusion Criteria:
1. Patients who are on NSAIDs , aspirin ,antioxidants or systemic steroids for more than 3 months and the last dose taken within the last one week.
2. Patients being treated for active infection at the time of starting high dose chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04870060
Study Brief:
Protocol Section:
NCT04870060