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

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT04998331
Collaborator
(none)
51
30
8
1.7
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No Intervention

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 Design

Study Type:
Observational
Actual Enrollment :
51 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Oct 29, 2021
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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
This is a non-interventional study.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Number of Participants Reporting one or More Adverse Events (AEs) [Up to 12 months]

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital General Vega Baja San Bartolome Alicante Spain 03314
2 Hospital Universitario de Alava Vitoria-Gasteiz Araba Spain 01009
3 Ico Hospitalet L'Hospitalet de Llobregat Barcelona Spain 08908
4 Hospital Universitario Galdakao Galdakao Bizkaia Spain 48960
5 Hospital Universitario Donostia Donostia Gipuzkoa Spain 20014
6 Hospital Universitario Gran Canaria Doctor Negrin Las Palmas de Gran Canaria Gran Canarias Spain 35010
7 Hospital Universitario Son Espases Palma de Mallorca Mallorca Spain 07120
8 Hospital Clinico Universitario Salamanca Salamanca Salamnaca Spain 37007
9 Hospital Nuestra Senora de Candelaria Santa Cruz de Tenerife Tenerife Spain 38010
10 Hospital Del Mar Barcelona Spain 08003
11 Hospital Vall D'Hebron Universitari Barcelona Spain 08035
12 Hospital Clinic I Provincial De Barcelona Barcelona Spain 08036
13 Hospital Santa Creu I Sant Pau Barcelona Spain 08041
14 Hospital Universitario Puerta del Mar Cadiz Spain 11009
15 Hospital Universitario de Jerez Cadiz Spain 11407
16 Hospital Universitario De La Princesa Madrid Spain 28006
17 Hospital Sanitas La Zarzuela Madrid Spain 28023
18 Hospital Universitario Infanta Leonor Madrid Spain 28031
19 Hospital Universitario Ramon y Cajal Madrid Spain 28034
20 Hospital Universitario Fundacion Jimenez Diaz Madrid Spain 28040
21 Hospital Universitario 12 De Octubre Madrid Spain 28041
22 Hospital. Universitario 12 De Octubre Madrid Spain 28041
23 Hospital Regional Universitario Malaga Malaga Spain 29010
24 Hospital General Universitario Morales Meseguer Murcia Spain 30008
25 Complejo Hospitalario Universitario de Pontevedra Pontevedra Spain 36071
26 Hospital Universitario Virgen Macarena Sevilla Spain 41009
27 Hospital Universitario Virgen de Valme Sevilla Spain 41014
28 Hospital Universitari I Politecnic La Fe De Valencia Valencia Spain 46026
29 Hospital Rio Hortega Valladolid Spain 47012
30 Hospital De Dia Quironsalud Zaragoza Zaragoza Spain 50012

Sponsors and Collaborators

  • Takeda

Investigators

  • Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT04998331
Other Study ID Numbers:
  • C25023
First Posted:
Aug 10, 2021
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Takeda
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022