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CompletedNCT01226472Updated Apr 25, 2024Results posted

Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001

A Phase 2 interventional study of KW-0761 in Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have relapsed after achieving a complete response in study, KW-0761-001.

02

Conditions studied

  • Peripheral T-cell Lymphoma
  • Cutaneous T-cell Lymphoma

Keywords

  • PTCL
  • CTCL
  • MF
  • SS
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 1 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. The subject has relapsed after achieving a complete response to treatment with KW 0761 for PTCL or CTCL on study, KW-0761-001.

      1. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of \< 2 at study entry.
      1. The subject is >18 years of age. 4. The subject has adequate hematological function: absolute neutrophil count [ANC] >1,500 cells/uL and platelets >100,000 cells/uL,except in patients with known bone marrow involvement where absolute neutrophil count [ANC] must be > 1,000 cells/uL and platelets >75,000 cells/uL.
      1. The subject has adequate hepatic function: bilirubin ≤ 1.5 times the specific institutional upper limit of normal [ULN]; aspartate transaminase [AST] and alanine transaminase [ALT] each ≤ 2.5 x ULN or ≤ 5.0 x ULN in the presence of known hepatic malignancy.
      1. The subject has serum creatinine ≤1.5 x ULN or a calculated creatinine clearance >60 mL/min.
      1. Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics.

Exclusion criteria

Exclusion Criteria:

  1. The subject has received any type of treatment for their disease since completing study, KW-0761-001.
  2. The subject has a significant uncontrolled intercurrent illness including, but not limited to: uncontrolled infection requiring antibiotics; clinically significant cardiac disease (class III or IV of the New York Heart Association [NYHA] classification); unstable angina pectoris; angioplasty, stenting, or myocardial infarction within 6 months; uncontrolled hypertension (systolic blood pressure >160 mmHg, diastolic BP >100 mmHg, found on two consecutive measurements separated by a 1 week period) despite two anti-hypertensive medications; clinically significant cardiac arrhythmia; or uncontrolled diabetes.
  3. Subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent to a daily dose of 10 mg of prednisone
  4. The subject has a psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit his or her compliance with study requirements.
  5. The subject has experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
  6. Subjects with active herpes simplex or herpes zoster.
  7. Subjects with known autoimmune diseases
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    KW-0761

    Biological: KW-0761

Interventions

  • BiologicalKW-0761

    In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.

06

What researchers measure

Primary outcomes

  1. Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging

    Time frame: one year

Secondary outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability.

    Time frame: one year

07

Results

Posted Dec 29, 2020

Participant flow

Participant flow — Overall Study
MilestoneKW-0761
Started1
Completed0
Not completed1
Withdrew: Progressive disease1

Outcome measures

PrimaryGlobal Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging
Time frame:
one year
Reported as:
Number · days
Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging
daysKW-0761
Progression-Free Survival (PFS)260
Time to Progression (TTP)260
Duration of Overall Response (DR)232
SecondaryNumber of Participants With Adverse Events as a Measure of Safety and Tolerability.
Time frame:
one year
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
ParticipantsKW-0761
With Any TEAE1
With Any Drug-related TEAE0
With Any TEAE with an Outcome of Death0
With Any Serious TEAE0
With Any Drug-related Serious TEAE0
With Any Serious TEAE with an Outcome of Death0

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
KW-07610/1 (0%)0/1 (0%)1/1 (100%)
Most frequent other events
Most frequent other events
EventKW-0761
HypophosphataemiaMetabolism and nutrition disorders1/1

Baseline characteristics

Only subjects with PTCL or CTCL who subsequently relapsed after achieving a CR in Study KW 0761-001 and who provided signed informed consent were eligible to enroll in the study.

Age, Categorical
Age, Categorical(Participants)KW-0761
<=18 years0
Between 18 and 65 years0
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)KW-0761
Female0
Male1
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)KW-0761
White, Hispanic or Latino1
Region of Enrollment
Region of Enrollment(participants)KW-0761
United States1
08

Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01226472
Lead sponsor
Kyowa Kirin Co., Ltd.
Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Responsible party
Sponsor
First posted
Oct 22, 2010
Start date
Aug 2010
Primary completion
Sep 2012
Completion
Sep 2012
Results posted
Dec 29, 2020
Last update
Apr 25, 2024

Study contacts

Michael Kurman, M.D.
study director · Kyowa Hakko Kirin Pharma, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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