Clinical trial NCT04998331: A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin
Official title: Effectiveness and Safety for Re-treatment With Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) CD30+ Malignancies: a Retrospective Medical Chart Review Study in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin Disease
Lymphoma, T-Cell, Cutaneous
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-08-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with R/R cHL, CTCL (MF and pcALCL) and sALCL, who have previously experienced a CR or PR with first BV treatment and subsequently experienced disease progression or relapse were administered BV retreatment will be included in this study.

Brief summary: Participants in the study are adults with CD30-positive malignancies which include classical Hodgkin lymphoma (cHL), cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF) or primarily cutaneous anaplastic large cell lymphoma (pcALCL), or systemic anaplastic large cell lymphoma (sALCL).

The main aims of the study are as follows:

* to learn about the response rates of participants with relapsed or refractory CD30+ malignancies when re-treated with BV.
* to check for side effects from re-treatment with BV.

The study will take place in approximately 30 hospitals in Spain.

The study doctors will review each participant's medical record at least 6 months after finishing the last dose of re-treatment with BV. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

Detailed description: This is an observational, non-interventional, retrospective study in participants with R/R CD30 positive cHL, CTCL (MF and pcALCL) and sALCL who have previously achieved a CR or PR with BV treatment and subsequently experienced disease progression were administered BV retreatment.

This study will assess the effectiveness and safety of BV retreatment in the Spanish population in real-world clinical practice. The study will enroll approximately 35 participants.

The data will be collected and recorded from the medical record of participants and also recorded in electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

• Participants With CD30-positive Lymphoma

This multi-center trial will be conducted in Spain. The overall duration of the study will be approximately 24 months (12 months for medical chart review and 12 until publication submission).

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed cHL, CTCL (MF and pcALCL) or sALCL with CD30 positive.
2. Previously treated with BV containing regimen, with evidence of objective response (determined by having achieved CR or PR), and subsequent disease progression or relapse after discontinuing treatment BV retreatment.
3. Participants with data of disease relapse or progression greater than or equal to (\>=) 6 months since the last dose of the first treatment with BV.
4. Participant with data available at the participating site since diagnosis of cHL, CTCL (MF and pcALCL) or sALCL.
5. Having received at least, two doses of BV as retreatment and having follow up information available at the site for a minimum period of six months or until death.

Exclusion Criteria:

There are no exclusion criteria for this study.

Primary outcomes:
measure: Overall Response Rate (ORR) as Assessed by Investigator Based on Positron Emission Tomography/Computerized Tomography (PET/CT) Status
timeFrame: Up to 6 months post-index date or death, whatever come first
measure: Number of Participants Reporting one or More Adverse Events (AEs)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Duration of Response (DOR) Based on PET/CT Status
timeFrame: Up to 6 months post-index date or death, whatever come first
measure: Overall Survival (OS)
timeFrame: From the index date to the date of death from any cause or end of follow-up (up to 6 months)
measure: Percentage of Participants With Complete Response Based on PET/CT Status
timeFrame: At the end of retreatment (up to 6 months post-index date or death, whatever come first)
measure: Time to Clinical Response (CR or PR)
timeFrame: From the index date to the date of documented CR or PR (up to 6 months)
measure: Time to Best Response
timeFrame: From the index date to first documentation of best response documented (up to 6 months)
measure: Time to Treatment Failure (TTF)
timeFrame: From the index date to first documentation of objective tumor progression or the day of death due to all causes (up to 6 months)
Other outcomes:
Locations:
city: San Bartolome
country: Spain
facility: Hospital General Vega Baja
state: Alicante
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario de Alava
state: Araba
city: L'Hospitalet de Llobregat
country: Spain
facility: Ico Hospitalet
state: Barcelona
city: Galdakao
country: Spain
facility: Hospital Universitario Galdakao
state: Bizkaia
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
state: Gipuzkoa
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Gran Canaria Doctor Negrin
state: Gran Canarias
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Mallorca
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario Salamanca
state: Salamnaca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Nuestra Senora de Candelaria
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron Universitari
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial De Barcelona
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Cadiz
country: Spain
facility: Hospital Universitario de Jerez
city: Madrid
country: Spain
facility: Hospital Universitario De La Princesa
city: Madrid
country: Spain
facility: Hospital Sanitas La Zarzuela
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Madrid
country: Spain
facility: Hospital. Universitario 12 De Octubre
city: Malaga
country: Spain
facility: Hospital Regional Universitario Malaga
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Valencia
country: Spain
facility: Hospital Universitari I Politecnic La Fe De Valencia
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
city: Zaragoza
country: Spain
facility: Hospital De Dia Quironsalud Zaragoza
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: