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Hodgkin DiseaseBELIEVENCT04998331

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

An observational study of Hodgkin Disease and Lymphoma, T-Cell, Cutaneous, run by Takeda at 30 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Disease, Lymphoma, T-Cell, Cutaneous
How many people
51 participants
Where
30 sitesSpain
Study dates
29 Oct 2021to 7 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • There are no exclusion criteria for this study.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Spain30 sites

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Vall D'Hebron Universitari

    Barcelona, 08035

  • Hospital Clinic I Provincial De Barcelona

    Barcelona, 08036

  • Hospital Santa Creu I Sant Pau

    Barcelona, 08041

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital Universitario de Jerez

    Cadiz, 11407

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Hospital Universitario Galdakao

    Galdakao, Bizkaia, 48960

  • Ico Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, Gran Canarias, 35010

  • Hospital Universitario De La Princesa

    Madrid, 28006

  • Hospital Sanitas La Zarzuela

    Madrid, 28023

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

  • Hospital. Universitario 12 De Octubre

    Madrid, 28041

  • Hospital Regional Universitario Malaga

    Málaga, 29010

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Universitario Son Espases

    Palma de Mallorca, Mallorca, 07120

  • Complejo Hospitalario Universitario de Pontevedra

    Pontevedra, 36071

  • Hospital Clinico Universitario Salamanca

    Salamanca, Salamnaca, 37007

  • Hospital General Vega Baja

    San Bartolomé, Alicante, 03314

  • Hospital Nuestra Senora de Candelaria

    Santa Cruz de Tenerife, Tenerife, 38010

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen de Valme

    Seville, 41014

  • Hospital Universitari I Politecnic La Fe De Valencia

    Valencia, 46026

  • Hospital Rio Hortega

    Valladolid, 47012

  • Hospital Universitario de Alava

    Vitoria-Gasteiz, Araba, 01009

  • Hospital De Dia Quironsalud Zaragoza

    Zaragoza, 50012

Other trials in Spain

About this study

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

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:

Read more
  • 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.

Read the 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).

Being tested
No Intervention
Keywords
Drug Therapy
Medical subject headings
Hodgkin Disease, Lymphoma, T-Cell, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    This is a non-interventional study.

Study groups in NCT04998331
Study groupRoleWhat they receive
Participants With CD30-positive LymphomaAll 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.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

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

    Measured: Up to 12 months

Secondary outcomes (6)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

    Measured: From the index date to first documentation of objective tumor progression or the day of death due to all causes (up to 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2021
  2. Study start29 Oct 2021
  3. Primary completion30 Apr 2022
  4. Study completion7 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04998331
Sponsor's protocol ID
C25023
Other IDs
EUPAS44653
Acronym
BELIEVE
Status last verified
Sep 2024
First submitted
6 Aug 2021
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

An observational study of Hodgkin Disease and Lymphoma, T-Cell, Cutaneous, run by Takeda at 30 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) as Assessed by Investigator Based on Positron Emission Tomography/Computerized Tomography (PET/CT) Status (time frame: Up to 6 months post-index date or death, whatever come first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04998331.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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