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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034205
Receipt No. R000038991
Scientific Title An investigator-initiated, multicenter, phase II study to determine the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory CD30-positive cutaneous T-Cell lymphoma
Date of disclosure of the study information 2019/01/01
Last modified on 2018/09/20

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Basic information
Public title An investigator-initiated, multicenter, phase II study to determine the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory CD30-positive cutaneous T-Cell lymphoma
Acronym An investigator-initiated, multicenter, phase II study to determine the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory CD30-positive cutaneous T-Cell lymphoma
Scientific Title An investigator-initiated, multicenter, phase II study to determine the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory CD30-positive cutaneous T-Cell lymphoma
Scientific Title:Acronym An investigator-initiated, multicenter, phase II study to determine the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory CD30-positive cutaneous T-Cell lymphoma
Region
Japan

Condition
Condition Cohort 1: Subjects with CD30+ mycosis fungoides or pcALCL
Cohort 2: Subjects with other (non-Cohort 1) CD30+ cutaneous T-Cell lymphomas
Classification by specialty
Hematology and clinical oncology Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of brentuximab vedotin in subjects with CD30-positive (CD30+) mycosis fungoides or primary cutaneous anaplastic large cell lymphoma (pcALCL) (Cohort 1) and subjects with other CD30+ Cutaneous T-Cell Lymphomas (Cohort 2)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of subjects achieving objective response lasting at least 4 months(ORR4) (per independent review facility [IRF] assessment)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The study drug will be administered by intravenous infusion over approximately 30 minutes on Day 1 of each 3 week cycle of treatment.
In the absence of infusion-related reactions, the infusion rate must be calculated in order to achieve a over 30 minute infusion period. If the study drug cannot be administered on Day 1 of a cycle, its reason and the actual date of dosing in the cycle should be recorded in the eCRF.
The dose of brentuximab vedotin is 1.8 mg/kg. However, for subjects with a over 10% change in body weight from the time of screening, the dose will be re-calculated and adjusted.
The dose calculation will use actual body weight except for patients weighing over 100 kg, for whom the dose will be calculated based on 100 kg.
The dose of the study drug will be rounded off to the nearest whole number of milligrams.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who provided written voluntary informed consent using the informed consent form approved by the institutional review board or equivalent.
2.Male or female patients aged 20 years or older at the time of consent
3.Patients with histologically confirmed CD30 positive cutaneous T Cell lymphomas by local histopathological assessment.
4.Patients with MF who have received at least one cycle of prior systemic therapy with inadequate response, or patients with pcALCL who have received prior radiotherapy or systemic therapy with inadequate response
5.Patients with an Eastern Cooperative Oncology Group Performance Status score of less than 2
6.Patients in whom all clinically important adverse effects of prior systemic therapy have resolved or improved in severity to grade less than 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0
7.Patients with laboratory data at screening meeting the following criteria:
a.Absolute neutrophil count over 1,500/mcL
b.Platelet count over 75,000/mcL
c.Bilirubin less than 1.5 times the upper limit of normal
d.Aspartate aminotransferase and alanine aminotransferase less than 3 times ULN
AST and ALT may be elevated up to 5 times the ULN if the elevation was determined to be due to hepatic involvement of the disease.
e.Creatinine clearance or calculated creatinine clearance over 40 mL/min
f.Hemoglobin must be over 8g/dL
8.Patients who agree to use appropriate contraception methods from the time of screening through the end of the study.
9.Patients who received antibody therapy, immunoglobulin-based immune therapy, or other monoclonal antibody therapies must have a 12-week washout interval between the time of informed consent and the start of study drug administration. However, the washout interval may be shortened to 3 weeks if judged to be appropriate by the investigator or subinvestigator.
Key exclusion criteria 1.Patients with concurrent systemic ALCL
2.Patients with concurrent Sezary syndrome or B2 disease
3.Patients with any of the following cardiovascular conditions or test values within 6 months before enrollment
a.Myocardial infarction.
b.New York Heart Association Class 3 or 4 heart failure
c.Any uncontrolled cardiovascular conditions
4.Patients with a history of another primary malignancy not in remission for at least 3 years.
5.Patients with known active cerebral
meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy
6.Patients with known HIV infection
7.Patients with known hepatitis B surface antigen positivity or known or suspected active hepatitis C infection
8.Patients with any severe active systemic viral, bacterial, or fungal infection requiring systemic treatment before the start of study drug administration.
9.Patients who received antibody directed or immunoglobulin based immune therapy within 12 weeks before study drug administration
10.Patients who received corticosteroid therapy for the treatment of CTCL within 3 weeks before study drug administration
11.Patients with known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation
12.Female patients who are pregnant or breastfeeding, or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 of any cycle
13.Patients who received treatment with radiotherapy, other skin directed therapy, or any investigational drug within 3 weeks before study drug administration
14.Patients with pancreatitis or significant risk factors for developing pancreatitis
15.Patients who previously received brentuximab vedotin before this study
16.Other patients judged by the investigator or subinvestigator to be inappropriate for participation in this study
Target sample size 15

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoji Hirai
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Dermatology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL 086-235-7282
Email gmd20033@s.okayama-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shiho Yoshida
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Center for Innovative Clinical Medicine
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL 086-235-6510
Homepage URL
Email pni29zv9@okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization Other
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 20 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038991

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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