Registry of BrentuximabVedotinin Patients With R/R Anaplastic Large Cell Lymphoma or Classical HL (BRAVO)

A Multi-center and Non-interventional Registry of BrentuximabVedotinin Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma or Classical Hodgkin Lymphoma

In case of relapsed or refractory ALK-negative ALCL patients, high-dosage chemotherapy/ stem cell transplantation is a universal salvage option for patients with sensitivity to anti-cancer treatment and a relatively successful salvage rate can be expected.

Recently, there has been a report of successful stem cell transplantation with full response to BrentuximabVedotin induced before stem cell transplantation and BrentuximabVedotin's role as a bridge therapy before stem cell transplantation has also been suggested.

Hodgkin lymphoma is a type of curable blood cancer with unique tissues and clinical characteristics. Based on the 2008 WHO classification, Hodgkin lymphoma has two types-nodular lymphocyte predominant type and classical type-and the classical type is further classified into four types, nodular sclerosis, mixed cellularity, lymphocyte depletion and lymphocyte-rich type.

Recently, immune checkpoint inhibitor is reported as a very effective treatment for relapsed Hodgkin lymphoma and more active treatment such as stem cell transplantation is considered for younger patients.

Treatment with Brentuximabvedotin targeting CD30+ is also very effective for the treatment of relapsed Hodgkin lymphoma and considered a good option for patients who are not suitable for stem cell transplantation or aged patients.

It shows consistent response to anti-CD30 antibody treatment in relation to relapsed anaplastic large cell lymphoma or Hodgkin lymphoma. The effect of Brentuximabvedotin (BV) has been proven for relapsed or intractable ALCL targeting CD30 as an antibody-chemical adhesive in the recent phase-2 study.

As Korea currently lacks real-world evidence in relation to BV, this study was conducted to address BV's effect as salvage therapy for patients with relapsed/refractoryanaplastic large cell lymphoma or Hodgkin lymphoma. This study identified the clinical results for treatment patterns and patients using the collected data and derived critical evidence for treatment decisions.

Study Overview

• Status: Completed
• Conditions: Relapsed or Refractory Anaplastic Large Cell Lymphoma & Hodgkin Lymphoma

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 06351
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Any patient planning to administer BrentuximabVedotin to treat the target disease;
2. Any patient administering BrentuximabVedotin to treat the target disease;
3. Any patient tracing BrentuximabVedotin after treating the target disease; or
4. Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.

Description

Inclusion Criteria:

Any patient subject to one of the following at the start of treatment with BrentuximabVedotin:

1. Any patient planning to administer BrentuximabVedotin to treat the target disease;
2. Any patient administering BrentuximabVedotin to treat the target disease;
3. Any patient tracing BrentuximabVedotin after treating the target disease; or
4. Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.

Exclusion Criteria:

1. If conditions for target diseases are not met.
2. If conditions for target patients are not met.
3. If patients do not give written consent to participate in study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort; Any patient planning to administer BrentuximabVedotin to treat the target disease.; Any patient administering BrentuximabVedotin to treat the target disease.; Any patient tracing BrentuximabVedotin after treating the target disease.; Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	Rate of patients with complete response and partial response based on Lugano classification.	3years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response retention period	From 1st dose date of Brentuximab Vedotin to progression date.	3years
Overall survival period	Period from start of salvage therapy with Brentuximab Vedotin to end of study.	3years
Length of time until next treatment	Length of time from start of salvage therapy with Brentuximab Vedotin to next salvage option after progress of disease.	3years

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, T-Cell; Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic
• Other Study ID Numbers: 2018-06-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No