UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034205 |
|---|---|
| Receipt number | 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 | 2023/04/03 11:24:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
Name of lead principal investigator
| 1st name | Yoji |
| Middle name | |
| Last name | Hirai |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Dermatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL
086-235-7282
gmd20033@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Yoshida |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Center for Innovative Clinical Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL
086-235-6510
Homepage URL
pni29zv9@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kitaku, Okayama Japan
Tel
086-235-7282
gmd20033@s.okayama-u.ac.jp
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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038991
