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

NCT04998331 | Completed FDA Drug

• 2 other identifiers: C25023EUPAS44653
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 30

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.

Conditions

Hodgkin Disease; Lymphoma, T-Cell, Cutaneous

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• Number of Participants Reporting one or More Adverse Events (AEs)

  Up to 12 months

Secondary Outcomes (6)

• Duration of Response (DOR) Based on PET/CT Status

  Up to 6 months post-index date or death, whatever come first

• Overall Survival (OS)

  From the index date to the date of death from any cause or end of follow-up (up to 6 months)

• Percentage of Participants With Complete Response Based on PET/CT Status

  At the end of retreatment (up to 6 months post-index date or death, whatever come first)

• Time to Clinical Response (CR or PR)

  From the index date to the date of documented CR or PR (up to 6 months)

• Time to Best Response

  From the index date to first documentation of best response documented (up to 6 months)

Study Arms (1)

Participants With CD30-positive Lymphoma

All participants diagnosed with relapsed/refractory (R/R) cHL, CTCL (mycosis fungoides \[MF\] and cutaneous anaplastic large cell lymphoma \[pcALCL\]) and sALCL with CD30 positive, and who have previously achieved a CR or PR with BV treatment and subsequently experienced disease progression/relapse and were administered BV retreatment will be observed retrospectively from their initiation of BV treatment until participant's inclusion date in the study or until treatment discontinuation due to toxicities or any cause. All study data will be collected retrospectively from the medical records.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

Participants With CD30-positive Lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Histologically confirmed cHL, CTCL (MF and pcALCL) or sALCL with CD30 positive.
• 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.
• 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.
• Participant with data available at the participating site since diagnosis of cHL, CTCL (MF and pcALCL) or sALCL.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (30)

Hospital General Vega Baja

San Bartolomé, Alicante, 03314, Spain

Location

Hospital Universitario de Alava

Vitoria-Gasteiz, Araba, 01009, Spain

Location

Ico Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario Galdakao

Galdakao, Bizkaia, 48960, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Hospital Universitario Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Gran Canarias, 35010, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Mallorca, 07120, Spain

Location

Hospital Clinico Universitario Salamanca

Salamanca, Salamnaca, 37007, Spain

Location

Hospital Nuestra Senora de Candelaria

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Vall D'Hebron Universitari

Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial De Barcelona

Barcelona, 08036, Spain

Location

Hospital Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario de Jerez

Cadiz, 11407, Spain

Location

Hospital Universitario De La Princesa

Madrid, 28006, Spain

Location

Hospital Sanitas La Zarzuela

Madrid, 28023, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

Location

Hospital. Universitario 12 De Octubre

Madrid, 28041, Spain

Location

Hospital Regional Universitario Malaga

Málaga, 29010, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Complejo Hospitalario Universitario de Pontevedra

Pontevedra, 36071, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

Location

Hospital Universitari I Politecnic La Fe De Valencia

Valencia, 46026, Spain

Location

Hospital Rio Hortega

Valladolid, 47012, Spain

Location

Hospital De Dia Quironsalud Zaragoza

Zaragoza, 50012, Spain

Location

Related Links

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

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 10, 2021
• Study Start: October 29, 2021
• Primary Completion: April 30, 2022
• Study Completion: September 7, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

ES (30)