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Cutaneous T-Cell LymphomaPhase 3NCT01728805

Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

A Phase 3 study testing KW-0761 and Vorinostat in people with Cutaneous T-Cell Lymphoma, run by Kyowa Kirin, Inc. at 73 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cutaneous T-Cell Lymphoma
What is being tested?
KW-0761 and Vorinostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
372 participants
Where
73 sitesin 11 countries
Study dates
Nov 2012to 17 Feb 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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 [β-HCG]) or lactating.
  • History of allogeneic transplant.

Trial locations and contacts

73 sites in 11 countries.

73 sites in 11 countries

United States34 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • The Winship Cancer Institute (Emory University)

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Medical Center, Department of Medicine, Section of Hem/Onc

    Boston, Massachusetts, 02118

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Northwestern University

    Chicago, Illinois, 60611

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Ohio State University

    Columbus, Ohio, 43210

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Universal Dermatology, PLLC

    Fairport, New York, 14450

  • Banner MD Anderson

    Gilbert, Arizona, 85234

  • M.D.Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53266

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University School of Medicine - Yale Cancer Center

    New Haven, Connecticut, 06520

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • Columbia Presbyterian

    New York, New York, 10037

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15208

  • University of Rochester School of Medicine

    Rochester, New York, 14642

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of Washington

    Seattle, Washington, 98109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Medical Center

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan19 sites

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaido, 078-8510

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • Tokyo Metropolitan Tama Medical Center

    Fuchu-shi, Tokyo, 183-8524

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 571-1191

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Imamura Bun-in Hospital

    Kagoshima, Kagoshima-ken, 890-0064

  • Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Shinshu University Hospital

    Matsumoto-shi, Nagano, 390-8621

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Kochi Medical School Hospital

    Nankoku-shi, Kochi, 783-8505

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Parkville Cancer Clinical Trials Unit

    Melbourne, Victoria, 3000

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

France4 sites

  • CHU de Nantes

    Nantes, 44093

  • Hôpital Saint Louis

    Paris, 75010

  • CHU Bordeaux - Hopital Haut-Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

Other trials in France

United Kingdom3 sites

  • University Hospital Birmingham

    Birmingham, B15 2TH

  • Guys & St. Thomas NHS Trust

    London, SE1 7EH

  • The Christie Hospital Foundation NHS Trust

    Manchester, Greater Manchester, M20 4BX

Other trials in United Kingdom

Germany2 sites

  • University Medical Centre Mannheim

    Mannheim, D-68167

  • University Hospital Muenster

    Münster, 48149

Other trials in Germany

Italy2 sites

  • Institute of Hematology and Oncology Lorenzo e Ariosto Seràgnoli, University of Bologna

    Bologna, 40138

  • Universita degli Studi di Torino

    Turin, 10124

Other trials in Italy

Spain2 sites

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

Denmark1 site

  • Aarhus University Hospital

    Aarhus, 8000

Other trials in Denmark

Netherlands1 site

  • Leiden University Medical Center - Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2300RC

Other trials in Netherlands

Switzerland1 site

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official 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

The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

Read the detailed description

Phase 3 randomized study to compare the progression free survival of subjects with relapsed/refractory CTCL who receive KW-0761 versus those who receive vorinostat. Subjects who progress on vorinostat will be allowed to cross over to KW-0761 upon progression.

Being tested
KW-0761, Vorinostat
Keywords
Cutaneous T-Cell Lymphoma (CTCL), myocis fungoides (MF), Sezary Syndrome (SS)
Medical subject headings
Lymphoma, T-Cell, Cutaneous, Sezary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KW-0761Biological

    Also called mogamulizumab, POTELIGEO®

    1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

  • VorinostatDrug

    Also called 400 mg orally daily, ZOLINZA®

Study groups in NCT01728805
Study groupRoleWhat they receive
KW-0761Experimentalanti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
Receives: Biological: KW-0761
VorinostatActive comparatorvorinostat 400 mg once daily
Receives: Drug: Vorinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression was defined as follows, based on Olsen (2011):

    • Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node > 1.5 cm in the long axis or > 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or > 50% increase from nadir in SPD of lymph nodes in those with PR
    • Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score
    • Blood: B0 to B2, > 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or > 50% increase from nadir and at least 5,000 neoplastic cells/μL
    • Viscera: > 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or > 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR

    Measured: 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 outcomes (3)

  1. Overall Response Rate

    The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment.

    Measured: 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

  2. Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score

    • Skindex-29 rates 29 items assessing 3 domains (emotions, symptoms, \& functioning) on a linear scale from 0 (never) to all the time (100). Higher scores = higher impact of skin disease.
    • FACT-G rates 27 items in 4 domains (physical well-being, social/family well-being, emotional well-being, functional well-being) on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores = better QoL.
    • EuroQoL lvl 3 (Eq-5D-3L) rates mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 3 levels - no problems, some problems, extreme problems. Score is calculated using a set of item weights to derive a single score ranging from -0.109 to 1, with 1 representing full health.

    LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.

    Measured: Cycle 1, 3, and 5

  3. Pruritis Evaluation

    The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life.

    LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.

    Measured: Cycle 1, 3, and 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionMar 2017
  4. Study completion17 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01728805
Sponsor's protocol ID
0761-010
Status last verified
Apr 2024
First submitted
25 Oct 2012
Last updated
25 Apr 2024
Data monitoring committee
Yes

Publications

  • Ortiz Romero PL, Kim YH, Molloy K, Quaglino P, Scarisbrick J, Thornton S, Sandilands K, Dent JE, Nixon A, Williams A, Shinohara MM. Health-related quality of life in cutaneous T-cell lymphoma: A post hoc analysis of a phase 3 trial in mycosis fungoides and Sezary syndrome. J Eur Acad Dermatol Venereol. 2025 Apr;39(4):833-845. doi: 10.1111/jdv.20357. Epub 2024 Sep 24.

    PubMed 39315857

  • Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. doi: 10.1016/S1470-2045(18)30379-6. Epub 2018 Aug 9.

    PubMed 30100375

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KW-0761 and Vorinostat in people with Cutaneous T-Cell Lymphoma, run by Kyowa Kirin, Inc. at 73 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Japan, Australia, France, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01728805, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.

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