UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

gmd20033@s.okayama-u.ac.jp

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

Email

pni29zv9@okayama-u.ac.jp

Institute

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name

Organization

Takeda Pharmaceutical Company Limited.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Okayama University Hospital

Address

2-5-1 Shikata-cho, Kitaku, Okayama Japan

Tel

086-235-7282

Email

gmd20033@s.okayama-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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