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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01728805




Registration number
NCT01728805
Ethics application status
Date submitted
25/10/2012
Date registered
20/11/2012
Date last updated
25/04/2024

Titles & IDs
Public title
Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
Scientific title
Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma
Secondary ID [1] 0 0
0761-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous T-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - KW-0761
Treatment: Drugs - Vorinostat

Experimental: KW-0761 - anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

Active Comparator: Vorinostat - vorinostat 400 mg once daily


Other interventions: KW-0761
1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Treatment: Drugs: Vorinostat
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months
Secondary outcome [2] 0 0
Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score
Timepoint [2] 0 0
Cycle 1, 3, and 5
Secondary outcome [3] 0 0
Pruritis Evaluation
Timepoint [3] 0 0
Cycle 1, 3, and 5

Eligibility
Key inclusion criteria
- Male and female subjects = 18 years of age at the time of enrollment, except in Japan
where subjects must be = 20 years of age at the time of enrollment

- Histologically confirmed diagnosis of mycosis fungoides (MF) or Sezary Syndrome (SS)

- Stage IB, II-A, II-B, III and IV

- Subjects who had failed at least one prior course of systemic therapy. Psoralen plus
ultraviolet light therapy (PUVA) is not considered to be a systemic therapy

- Eastern Cooperative Oncology Group (ECOG) performance status score of = 1 at study
entry

- Resolution of all clinically significant toxic effects of prior cancer therapy to
grade =1 by the National Cancer Institute Common Terminology Criteria for Adverse
Events, version 4.0 (NCI-CTCAE, v.4.0)

- Adequate hematological, renal and hepatic function

- Subjects previously treated with anti-CD4 antibody or alemtuzumab were eligible
provided their CD4+ cell counts were = 200/mm3

- Subjects with mycosis fungoides (MF) and a known history of non-complicated
staphylococcus infection/colonization were eligible provided they continued to receive
stable doses of prophylactic antibiotics

- Women of childbearing potential (WOCBP) must have had a negative pregnancy test within
7 days of receiving study medication

- WOCBP and male subjects as well as their female partners of childbearing potential
must have agreed to use effective contraception throughout the study and for 3 months
after the last dose of KW-0761
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with KW-0761 or vorinostat.

- Large cell transformation. However, subjects with a history of LCT but without current
aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes
would be eligible.

- Diagnosed with a malignancy in the past two years. However, subjects with non-melanoma
skin cancers, melanoma in situ, localized cancer of the prostate with current PSA of
<0.1 ng/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular
carcinoma in situ of the breast within the past two years could enroll as long as
there was no current evidence of disease.

- Clinical evidence of central nervous system (CNS) metastasis.

- Psychiatric illness, disability or social situation that would have compromised the
subject's safety or ability to provide consent, or limited compliance with study
requirements.

- Significant uncontrolled intercurrent illness

- Known or tested positive for human immunodeficiency virus (HIV), human T-cell leukemia
virus (HTLV-1), hepatitis B or hepatitis C.

- Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started
taking medication at least 30 days prior to study entry, and had no active signs of
active infection, and whose last active infection was more than 6 months ago, could
enter the study, and should have continued to take the prescribed medication for the
duration of the study.

- Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.

- Known active autoimmune disease were excluded. (For example, Grave's disease; systemic
lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).

- Was pregnant (confirmed by beta human chorionic gonadotrophin [ß-HCG]) or lactating.

- History of allogeneic transplant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2021
Sample size
Target
Accrual to date
Final
372
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Parkville Cancer Clinical Trials Unit - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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United States of America
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Louisiana
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Massachusetts
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Michigan
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Missouri
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New Hampshire
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Washington
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Wisconsin
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Denmark
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Aarhus
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France
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Nantes
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France
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Paris
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France
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Pessac
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France
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Pierre-Benite Cedex
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Germany
State/province [30] 0 0
Mannheim
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Germany
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Muenster
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Italy
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Bologna
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Italy
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Turin
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Japan
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Aichi
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Japan
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Fukushima
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Gunma
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Hiroshima
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Hokkaido
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Kagoshima
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Kanagawa
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Kochi
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Mie
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Miyagi
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Nagano
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Okayama
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Netherlands
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Leiden
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Spain
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Madrid
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Spain
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Salamanca
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Switzerland
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Zurich
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United Kingdom
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Greater Manchester
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United Kingdom
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Birmingham
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kyowa Kirin, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the progression free survival of KW-0761 versus
vorinostat for subjects with relapsed or refractory CTCL.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01728805
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dmitri O. Grebennik, MD
Address 0 0
Kyowa Kirin, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01728805