Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT05100056
Brief Summary:
The main aim is to check how effective BV is for treating adults with HL.
Study medication will be prescribed according to the clinic's standard practice.
Participants will visit the study clinic 5 times, once every 12 weeks. When study treatment has completed, a follow-up visit will be scheduled every 3 months during the first year and every 4-6 months during the next year.
Detailed Description:
This is a prospective, observational study in participants with HL who underwent or are candidates for ASCT and receiving or will receive the standard treatment of BV. This study will assess the safety profile and effectiveness of BV in pre and post-ASCT in the real-world clinical practice.
The study will enroll approximately 70 participants.
The data will be collected and recorded in electronic case report forms (e-CRFs) in scope of National Drug Program (NDP). All the participants will be assigned to two observational cohorts:
* HL Participants: BV Salvage Pre-ASCT
* HL Participants: BV Consolidation Treatment Post-ASCT
This multi-center trial will be conducted in Poland. All participants will be followed up for 24 months. The overall duration of the study will be approximately 4.5 years.
Study:
NCT05100056
Study Brief:
Protocol Section:
NCT05100056