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

Completed

• Conditions: Hodgkin Disease; Lymphoma, T-Cell, Cutaneous
• Interventions: Other: No Intervention

• Registration Number: NCT04998331
• Lead Sponsor: Takeda

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).

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-10
• Study Start: 2021-10-29
• Primary Completion: 2022-04-30
• Study Completion: 2023-09-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

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Exclusion Criteria

There are no exclusion criteria for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants With CD30-positive Lymphoma	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting one or More Adverse Events (AEs)	Up to 12 months
Overall Response Rate (ORR) as Assessed by Investigator Based on Positron Emission Tomography/Computerized Tomography (PET/CT) Status	Up to 6 months post-index date or death, whatever come first	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR) Based on PET/CT Status	Up to 6 months post-index date or death, whatever come first	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.
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)	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.
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 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.
Time to Best Response	From the index date to first documentation of best response documented (up to 6 months)	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.
Time to Treatment Failure (TTF)	From the index date to first documentation of objective tumor progression or the day of death due to all causes (up to 6 months)	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.
Overall Survival (OS)	From the index date to the date of death from any cause or end of follow-up (up to 6 months)	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.

Trial Locations

Locations (30)

Hospital Universitario de Alava; 🇪🇸 Vitoria-Gasteiz, Araba, Spain

Hospital Universitario Donostia; 🇪🇸 Donostia, Gipuzkoa, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma de Mallorca, Mallorca, Spain

Hospital Universitario Gran Canaria Doctor Negrin; 🇪🇸 Las Palmas de Gran Canaria, Gran Canarias, Spain

Hospital Clinico Universitario Salamanca; 🇪🇸 Salamanca, Salamnaca, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Hospital Nuestra Senora de Candelaria; 🇪🇸 Santa Cruz de Tenerife, Tenerife, Spain

Hospital Vall D'Hebron Universitari; 🇪🇸 Barcelona, Spain

Hospital Clinic I Provincial De Barcelona; 🇪🇸 Barcelona, Spain

Hospital Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario De La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta del Mar; 🇪🇸 Cadiz, Spain

Hospital Universitario de Jerez; 🇪🇸 Cadiz, Spain

Hospital Sanitas La Zarzuela; 🇪🇸 Madrid, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

Hospital. Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

Hospital Regional Universitario Malaga; 🇪🇸 Malaga, Spain

Hospital General Universitario Morales Meseguer; 🇪🇸 Murcia, Spain

Complejo Hospitalario Universitario de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitari I Politecnic La Fe De Valencia; 🇪🇸 Valencia, Spain

Hospital Rio Hortega; 🇪🇸 Valladolid, Spain

Hospital De Dia Quironsalud Zaragoza; 🇪🇸 Zaragoza, Spain

Hospital Universitario Galdakao; 🇪🇸 Galdakao, Bizkaia, Spain

Ico Hospitalet; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital General Vega Baja; 🇪🇸 San Bartolome, Alicante, Spain

Hospital Universitario Virgen de Valme; 🇪🇸 Sevilla, Spain