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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029982
Receipt No. R000034244
Scientific Title A Retrospective Study of Safety and Efficacy for Re-treatment of Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) classical Hodgkin Lymphoma (cHL)/ systemic Anaplastic Large-cell Lymphoma (sALCL)
Date of disclosure of the study information 2017/11/15
Last modified on 2018/08/03

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Basic information
Public title A Retrospective Study of Safety and Efficacy for Re-treatment of Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) classical Hodgkin Lymphoma (cHL)/ systemic Anaplastic Large-cell Lymphoma (sALCL)
Acronym A Retrospective Study of Safety and Efficacy for Re-treatment of Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) classical Hodgkin Lymphoma (cHL)/ systemic Anaplastic Large-cell Lymphoma (sALCL)
Scientific Title A Retrospective Study of Safety and Efficacy for Re-treatment of Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) classical Hodgkin Lymphoma (cHL)/ systemic Anaplastic Large-cell Lymphoma (sALCL)
Scientific Title:Acronym A Retrospective Study of Safety and Efficacy for Re-treatment of Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) classical Hodgkin Lymphoma (cHL)/ systemic Anaplastic Large-cell Lymphoma (sALCL)
Region
Japan

Condition
Condition CD30 positive cHL or sALCL
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to confirm the efficacy and safety in Japanese population who are administered with brentuximab vedotin retreatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Number of Participants who Experience at least one Treatment-Emergent Adverse Events (TEAE), Overall response rate (ORR)
Key secondary outcomes Complete response rate (CR rate), Progression-free survival (PFS), Duration of response (DOR), Time to treatment failure (TTF)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. cHL or sALCL patients with CD30 positive
2. Patients who previously experienced a CR or PR with first brentuximab vedotin treatment and subsequently experienced disease progression or relapse were administered brentuximab vedotin retreatment*.
*Definition of brentuximab vedotin retreatment
1) Discontinued treatment of brentuximab vedotin as prior therapy after experienced a CR or PR.
2) At least single dose of brentuximab vedotin was administered after discontinued treatment of brentuximab vedotin and subsequently experienced disease progression or relapse.
3) Treatment of brentuximab vedotin after 6 weeks or more passed from the date of final dose of prior treatment of brentuximab vedotin.
4) Not the treatment of brentuximab vedotin as consolidation after SCT.
5) Monotherapy of retreatment of brentuximab vedotin (not concomitant use with other antitumor agent)
6) Re-retreatment (in the case that retreatment of brentuximab vedotin was administered after discontinued retreatment of brentuximab vedotin described above) is handled as a set of retreatment).
3. A patient who agreed with informed consent prior to the study enrollment.
Key exclusion criteria 1. Patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study (such as patients who may be coerced to give consent)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jumpei Soeda
Organization Takeda Pharmaceutical Company Limited
Division name Strategic Medical Research Planning, Global Medical Affairs-Japan,
Zip code
Address 12-10, Nihonbashi 2-chome, Chuo-ku,Tokyo 103-8668
TEL 03-3278-2111
Email C25016@sogo-medefi.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeda Study Registration Call Center
Organization Takeda Pharmaceutical Company Limited
Division name Strategic Medical Research Planning, Global Medical Affairs-Japan,
Zip code
Address 12-10, Nihonbashi 2-chome, Chuo-ku,Tokyo 103-8668
TEL 03-3278-2111
Homepage URL
Email C25016@sogo-medefi.jp

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JapicCTI-173771
Org. issuing International ID_1 Japan Pharmaceutical Information Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 15 Day
Last follow-up date
2018 Year 06 Month 25 Day
Date of closure to data entry
2018 Year 06 Month 25 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information The purpose of this study is to confirm the efficacy and safety in Japanese population who are administered with brentuximab vedotin retreatment.

Management information
Registered date
2017 Year 11 Month 15 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034244

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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