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Trial record 8 of 877 for:    "Reticulum Cell Sarcoma"

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

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ClinicalTrials.gov Identifier: NCT03766516
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Kim, Seok Jin, Samsung Medical Center

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
Relapsed or Refractory Anaplastic Large Cell Lymphoma & Hodgkin Lymphoma

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 3 Years
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 : November 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021


Group/Cohort
Cohort
  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.
  4. Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.



Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 3years ]
    Rate of patients with complete response and partial response based on Lugano classification.


Secondary Outcome Measures :
  1. Response retention period [ Time Frame: 3years ]
    From 1st dose date of Brentuximab Vedotin to progression date.

  2. Overall survival period [ Time Frame: 3years ]
    Period from start of salvage therapy with Brentuximab Vedotin to end of study.

  3. Length of time until next treatment [ Time Frame: 3years ]
    Length of time from start of salvage therapy with Brentuximab Vedotin to next salvage option after progress of disease.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766516


Contacts
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Contact: Seok Jin Kim, Ph.D 82-2-3410-1766 seokjin88.kim@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Gangnam-Gu, Korea, Republic of, 06351
Contact: Seok Jin Kim, Ph.D    82-2-3410-1766    seokjin88.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center

Additional Information:

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Responsible Party: Kim, Seok Jin, Principal Investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03766516     History of Changes
Other Study ID Numbers: 2018-06-006
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell