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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03766516
Collaborator
(none)
90
Enrollment
1
Location
37.9
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    A Multi-center and Non-interventional Registry of BrentuximabVedotinin Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma or Classical Hodgkin Lymphoma
    Actual Study Start Date :
    Nov 1, 2018
    Actual Primary Completion Date :
    Dec 30, 2021
    Actual Study Completion Date :
    Dec 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate [3years]

      Rate of patients with complete response and partial response based on Lugano classification.

    Secondary Outcome Measures

    1. Response retention period [3years]

      From 1st dose date of Brentuximab Vedotin to progression date.

    2. Overall survival period [3years]

      Period from start of salvage therapy with Brentuximab Vedotin to end of study.

    3. Length of time until next treatment [3years]

      Length of time from start of salvage therapy with Brentuximab Vedotin to next salvage option after progress of disease.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Gangnam-Gu Korea, Republic of 06351

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kim, Seok Jin, Principal Investigator, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT03766516
    Other Study ID Numbers:
    • 2018-06-006
    First Posted:
    Dec 6, 2018
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Hodgkin Disease
    Lymphoma, Large-Cell, Anaplastic

    Study Results

    No Results Posted as of Feb 7, 2022