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

Takeda

Status: Completed

Conditions: Hodgkin Disease; Lymphoma, T-Cell, Cutaneous

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04998331

EUPAS44653 (Other Identifier)

C25023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

51 participants in 1 patient group

Participants With CD30-positive Lymphoma

Description:

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.

Treatment:

Other: No Intervention