Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT05100056
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2021-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Effectiveness and Safety of Consolidative Brentuximab Vedotin (BV) Treatment Administered to Hodgkin's Lymphoma (HL) Patients That Had Undergone Autologous Stem Cell Transplant (ASCT). Prospective, Multicenter, Observational Study
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BV-MAZOVIA
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: