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NCT01226472 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2024-04-25

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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. 2\. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of \< 2 at study entry. 3\. 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. 5\. 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. 6\. The subject has serum creatinine ≤1.5 x ULN or a calculated creatinine clearance \>60 mL/min. 7\. Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics. 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Biological: KW-0761
    label
    KW-0761
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. KW-0761
    description
    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.
    name
    KW-0761
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    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. measure
    Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
    time Frame
    one year
Full study description
brief 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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-d7b903b2cd6a39c1e6ab
      requested nct id
      NCT01226472
      primary nct id
      NCT01226472
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      payload sha256
      3ff4efea8eb2074dca15e4d9fb5798f25719383a0b30b42b9c3c688c9dca15c9
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-d7b903b2cd6a39c1e6ab
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01226472
      occurrences
      1. context exact
        NCT01226472
        end
        11
        exact text
        NCT01226472
        start
        0
      offset unit
      unicode_code_points
      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      source json pointer
      /studies/26/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      0fb637ec7304b55eb69fcd7fc708d0a1107ca73b38a55e7573b954a170ccfecf

    Preserved source evidence · Not medical advice