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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT04822532
Eligibility Criteria:
Inclusion Criteria:
* Patients must be aged from 0-18 years old on entry to the study;
* Clinical indication of allogeneic or autologous hematopoietic stem cell transplantation;
* The conditioning protocol must include IV Bu formulations, Busulfex® (Otsuka Pharmaceutical), Busilvex® (Pierre Fabre Pharma) or other European Medicines Agency (EMA) or Food and Drugs Administration (FDA) approved generic formulations regardless of the administration schedule (q6h, q12h, or q24h)
* The expected length of time from recruitment to starting the conditioning regimen must be superior to 10 days;
* Informed written consent to participate in the study signed by the participant/parent
Exclusion Criteria:
• At least one of the drugs listed below scheduled to be administered in the Bu administration days up to 24h after the last dose of Bu, whenever a washout is not possible:
* Metronidazol (required washout: 7 days)
* Nalidixic acid (required washout: 7 days)
* Phenytoin (required washout: 21 days)
* Itraconazole (required washout: 14 days)
* Ketoconazole (required washout: 7 days)
* Voriconazole (required washout: 7 days)
* Deferasirox (required washout: 7 days)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT04822532
Study Brief:
Protocol Section:
NCT04822532