BV-MAZOVIA: A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma

Sponsor
Takeda (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05100056
Collaborator
(none)
70
Enrollment
15
Locations
37.6
Anticipated Duration (Months)
4.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: No Intervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

ArmIntervention/Treatment
HL Participants: BV Salvage Pre-ASCT

Participants diagnosed with HL who undergone or undergoing pre-ASCT BV salvage and continue with post-ASCT treatment will be observed prospectively over 24-month period after treatment cessation.

Other: No Intervention
This is a non-interventional study.

HL Participants: BV Consolidation Treatment Post-ASCT

Participants diagnosed with HL who undergone or undergoing post-ASCT BV consolidation treatment will be observed prospectively over 24-month period after treatment cessation.

Other: No Intervention
This is a non-interventional study.

Outcome Measures

Primary Outcome Measures

  1. Progression Free Survival (PFS) as Assessed by Investigator [From initiation of BV treatment post-ASCT until disease progression or relapse, or death (up to 36 months)]

    PFS will be assessed by investigator and defined as the time from the first dose of BV post ASCT until the first occurrence of disease progression or relapse, or death for any reason. Disease progression is at least a 50 percent (%) increase in the size of lesions, or the occurrence of new lesions. It will be analyzed using Kaplan-Meier method.

Secondary Outcome Measures

  1. Overall Survival (OS) [From initiation of BV treatment until death from any cause (up to 36 months)]

    OS is defined as the time from initiation of therapy to death from any cause. It will be analyzed using Kaplan-Meier method.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Adult participant (aged greater than or equal to [>=18] years) that underwent or are candidates for ASCT and were enrolled in BV HL NDP receiving treatment according to the Summary of Product Characteristics for Adcetris and NDP.
Exclusion Criteria:
  1. Currently participates or plans to participate in any interventional clinical trial.

  2. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WroclawiuWroclawDolnoslskiePoland50-556
2Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, im. M. Kopernika w LodziLodzLodzkiePoland93-513
3Samodzielny Publiczny Szpital Kliniczny Nr 1LublinLubelskiePoland20-081
4Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z DukliLublinLubelskiePoland20-090
5Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w KrakowieKrakowMalopolskiePoland31-115
6Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w KrakowieKrakowMalopolskiePoland31-501
7NU-MED Specjalistyczny Szpital Onkologiczny Tomaszow MazowieckiTomaszow MazowieckiMazowieckiePoland97-200
8Uniwersyteckie Centrum Kliniczne WUMWarszawaMazowieckiePoland02-097
9Instytut Hematologii i TransfuzjologiiWarszawaMazowieckiePoland02-776
10Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyWarszawaMazowieckiePoland02-781
11Uniwersyteckie Centrum Kliniczne, GdanskGdanskPomorskiePoland80-214
12Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w GliwicachGliwiceSlskiePoland44-102
13Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slskiego Uniwersytetu Medycznego w KatowicachKatowiceSlskiePoland40-027
14Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w OlsztynieOlsztynWarminsko-mazurskiePoland10-228
15Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w PoznaniuPoznanWielkopolskiePoland61-848

Sponsors and Collaborators

  • Takeda

Investigators

  • Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT05100056
Other Study ID Numbers:
  • Brentuximab-5018
First Posted:
Oct 29, 2021
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Takeda
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2022