A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin

Hodgkin Disease Clinical Trial

— BELIEVE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04998331
• Other study ID #: C25023
• Status: Active, not recruiting
• Start date: October 29, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinic I Provincial De Barcelona	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Santa Creu I Sant Pau	Barcelona
Spain	Hospital Vall D'Hebron Universitari	Barcelona
Spain	Hospital Universitario de Jerez	Cadiz
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Universitario Donostia	Donostia	Gipuzkoa
Spain	Hospital Universitario Galdakao	Galdakao	Bizkaia
Spain	Ico Hospitalet	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Gran Canaria Doctor Negrin	Las Palmas de Gran Canaria	Gran Canarias
Spain	Hospital Sanitas La Zarzuela	Madrid
Spain	Hospital Universitario 12 De Octubre	Madrid
Spain	Hospital Universitario De La Princesa	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital. Universitario 12 De Octubre	Madrid
Spain	Hospital Regional Universitario Malaga	Malaga
Spain	Hospital General Universitario Morales Meseguer	Murcia
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Mallorca
Spain	Complejo Hospitalario Universitario de Pontevedra	Pontevedra
Spain	Hospital Clinico Universitario Salamanca	Salamanca	Salamnaca
Spain	Hospital General Vega Baja	San Bartolome	Alicante
Spain	Hospital Nuestra Senora de Candelaria	Santa Cruz de Tenerife	Tenerife
Spain	Hospital Universitario Virgen de Valme	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitari I Politecnic La Fe De Valencia	Valencia
Spain	Hospital Rio Hortega	Valladolid
Spain	Hospital Universitario de Alava	Vitoria-Gasteiz	Araba
Spain	Hospital De Dia Quironsalud Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) as Assessed by Investigator Based on Positron Emission Tomography/Computerized Tomography (PET/CT) Status	ORR is the percentage of participants whose best overall response (graded by favorability in the order of clinical response [CR], partial response [PR], stable disease [SD], progressive disease [PD], and not evaluable [NE]) from initiation of BV retreatment to the discontinuation or end of treatment according to response criteria is either CR or PR. ORR will be assessed by investigator using 5-point scale for visually assessing response on the pre and end-of-treatment PET/CT scans. The 5-point scale ranges from: 1 (No uptake), 2 (Uptake less than or equal to [<=] mediastinum), 3 (Uptake greater than [>] mediastinum but <=liver), 4 (Uptake moderately >liver), and 5 (Uptake markedly higher than liver and/no new lesions). Total score ranges from 0-5. In case of unavailability of PET/CT scans, ORR will be assessed as per Revised Criteria for Response Assessment for Malignant Lymphoma. Index date: eligible participants who start BV as retreatment.	Up to 6 months post-index date or death, whatever come first
Primary	Number of Participants Reporting one or More Adverse Events (AEs)		Up to 12 months
Secondary	Duration of Response (DOR) Based on PET/CT Status	DOR will be calculated as the time (months) from the first documentation of a confirmed CR or PR (whichever is first recorded) to the date of objective PD or death from any cause, whichever is earliest. DOR will be assessed by investigator using 5-point scale for visually assessing response on the pre and end-of-treatment PET/CT scans. The 5-point scale ranges from: 1 (No uptake), 2 (Uptake <=mediastinum), 3 (Uptake >mediastinum but <=liver), 4 (Uptake moderately >liver), and 5 (Uptake markedly higher than liver and/no new lesions). Total score ranges from 0-5. In case of unavailability of PET/CT scans, DOR will be assessed as per Revised Criteria for Response Assessment for Malignant Lymphoma. Index date: eligible participants who start BV as retreatment.	Up to 6 months post-index date or death, whatever come first
Secondary	Overall Survival (OS)	OS will be calculated as time (months) from the index date (date of initiation of BV as retreatment) to the date of death from any cause or end of follow-up. Participants alive at the end of the study period will be censored. Index date: eligible participants who start BV as retreatment.	From the index date to the date of death from any cause or end of follow-up (up to 6 months)
Secondary	Percentage of Participants With Complete Response Based on PET/CT Status	Complete response will be assessed by investigator using 5-point scale for visually assessing response on the pre and end-of-treatment PET/CT scans. The 5-point scale ranges from: 1 (No uptake), 2 (Uptake <=mediastinum), 3 (Uptake >mediastinum but <=liver), 4 (Uptake moderately >liver), and 5 (Uptake markedly higher than liver and/no new lesions). Total score ranges from 0-5. In case of unavailability of PET/CT scans, complete response will be assessed as per Revised Criteria for Response Assessment for Malignant Lymphoma. Index date: eligible participants who start BV as retreatment.	At the end of retreatment (up to 6 months post-index date or death, whatever come first)
Secondary	Time to Clinical Response (CR or PR)	Time to clinical response will be calculated from the date of index date (date of initiation of BV as retreatment) to the date of documented CR or PR. Index date: eligible participants who start BV as retreatment.	From the index date to the date of documented CR or PR (up to 6 months)
Secondary	Time to Best Response	Time to best response will be calculated as the time from the index date (date of initiation of BV as retreatment) to first documentation of best response documented. Tumor response will be based on tumour assessments carried out as per local practice. Index date: eligible participants who start BV as retreatment.	From the index date to first documentation of best response documented (up to 6 months)
Secondary	Time to Treatment Failure (TTF)	TTF will be calculated as the time from the index date (date of initiation of BV as retreatment) to first documentation of objective tumor progression or the day of death due to all causes whichever comes earlier. Tumor response will be based on tumour assessments carried out as per local practice. Index date: eligible participants who start BV as retreatment.	From the index date to first documentation of objective tumor progression or the day of death due to all causes (up to 6 months)

External Links

•   To obtain more information on the study, click here/on this link