No intervention
OtherThis is a non-interventional study.
NCT Number: NCT04998331
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.
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Notify Me18 year and older
All sexes
Observational
Hospital General Vega Baja, San Bartolomé, Alicante, Spain
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:
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
There are no exclusion criteria for this study.
This is a non-interventional study.
Time frame: 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.
Time frame: Up to 12 months
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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 frame: 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 frame: 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.
Takeda
Industry
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
Acronym: BELIEVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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