Aurora, Colorado 80045

  • Cell Lymphoma

Purpose:

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


Study summary:

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.


Criteria:

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 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 [β-HCG]) or lactating. - History of allogeneic transplant.


Study is Available At:


Original ID:

0761-010


NCT ID:

NCT01728805


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Kyowa Kirin, Inc.


Oversight Authority:

  • United States: Food and Drug Administration
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency
  • France: Agence Nationale de Sécurité du Médicament et des produits de santé
  • Spain: Agencia Española de Medicamentos y Productos Sanitarios
  • Italy: The Italian Medicines Agency
  • Denmark: Danish Health and Medicines Authority
  • Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
  • Germany: Paul-Ehrlich-Institut
  • Switzerland: Swissmedic
  • Japan: Pharmaceuticals and Medical Devices Agency
  • Australia: Human Research Ethics Committee


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

372


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dmitri O. Grebennik, MD
Study Director
Kyowa Kirin, Inc.

Study Dates

Start Date:November 2012
Completion Date:February 17, 2021
Completion Type:Actual
Primary Completion Date:March 2017
Primary Completion Type:Actual
Verification Date:April 2021
Last Changed Date:April 28, 2021
First Received Date:October 25, 2012
First Results Date:October 11, 2018

Study Outcomes

Outcome Type: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
Safety Issues:False
Description: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 hist
Outcome Type:Secondary Outcome
Measure:Pruritis Evaluation
Time Frame:Cycle 1, 3, and 5
Safety Issues:False
Description: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 scor
Outcome Type:Secondary Outcome
Measure:Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score
Time Frame:Cycle 1, 3, and 5
Safety Issues:False
Description: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/f
Outcome Type:Secondary Outcome
Measure:Overall Response Rate
Time Frame:at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13),
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:Vorinostat
Arm Name:Vorinostat
Other Name:400 mg orally daily
Intervention Type:Biological
Name:KW-0761
Description:1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Arm Name:KW-0761
Other Name:mogamulizumab

Study Arms

Study Arm Type:Experimental
Arm Name:KW-0761
Description:anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
Study Arm Type:Active Comparator
Arm Name:Vorinostat
Description:vorinostat 400 mg once daily

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Kyowa Kirin, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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