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NCT00355472 · REGISTRY CONDITION SEARCH

Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL

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

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2012-10-18

This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).

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

Incidence of Dose-Limiting Toxicities (DLTs)

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outcome · POSTED

Maximum Tolerated Dose (MTD)

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outcome · POSTED

Antitumor Effect

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outcome · POSTED

Pharmacokinetics-Plasma KW-0761 Concentrations

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outcome · POSTED

Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (AUC0-7 Days)

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outcome · POSTED

Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (t1/2)

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outcome · POSTED

Time to Progression (TTP)

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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\. Histologically confirmed diagnosis of a CCR4-positive ATL and PTCL that is any of the following: A. ATL (Adult T-Cell Leukemia-Lymphoma) * Seropositive for anti-Human T-lymphotrophic Virus type-I (HTLV-I) antibody; * Acute, Lymphoma, or Chronic phase with high-risk factors (within 14 days before the study entry); B. PTCL (Peripheral T-Cell Lymphoma) * Includes Mycosis Fungoides and Sezary Syndrome; 2: Relapsed to the latest standard chemotherapy; 3: Received at least one prior chemotherapy; 4: After 4 weeks from a prior therapy; 5: Have measurable disease; 6:Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1; 7: Male or female, at least 20 years and not older than 70 years of age; 8: Signed written informed consent; 9: Stay in hospital for 4 weeks; 10: HBs antigen: negative, HBV-DNA: below the limit of quantification (within 14 days before the study entry); 11: Adequate bone marrow, hepatic and cardiac function including the followings: * Neutrophil count ≥ 1,500 /mm3, * Platelets ≥ 75,000 /mm3, * Hemoglobin ≥ 8.0 g/dL * Serum creatinine ≤ 1.5 x ULN; * Serum SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN (≤ 5.0 x ULN if considered due to disease involvement in liver); * Serum bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if considered due to disease involvement in liver) * Serum calcium ≤ 11.0 mg/dL * PaO2 ≥ 65 mmHg or SaO2 ≥ 90% * No clinically significant Electrocardiogram abnormality * Left Ventricular Ejection Fraction ≥ 50% \[by ECHO or MUGA\] Exclusion Criteria: 1. Co-existing active infection or any co-existing medical condition that may compromise the safety of patients during the study, affect the patient's ability to complete the study, or interfere with interpretation of study results; 2. Active tuberculosis; 3. Prior stem cell transplantation; 4. Myocardial infarction (within 12 months prior to the study entry); 5. Concurrent acute or chronic hepatitis, or cirrhosis; 6. Anti-HCV: positive, Anti-HIV: positive 7. Concurrent active malignant disease; 8. Known allergic reaction to antibody therapy; 9. Concomitant treatment with systemic steroids; 10. Prior and Concurrent psychiatric disorder including dementia, epilepsy or any other CNS diseases; 11. Evidence of CNS metastasis at baseline; 12. Prior and Concurrent spinal cord disease; 13. Radiation therapy for bulky mass disease at the time of study entry or considered to require radiation therapy during the study; 14. Female patients who are pregnant or breast feeding; 15. Female patients of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with the institution's standards; 16. Treatment with any other investigational agent within the 4 months prior to study entry; 17. For any reason is judged by the Investigator to be inappropriate for study participation, including an inability to communicate or cooperate with the Investigator.
healthy Volunteers
false
maximum Age
69 Years
minimum Age
20 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    KW-0761
    intervention Names
    1. Drug: KW-0761
    label
    1
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. 1
    description
    IV administration at 4 escalating dose levels.
    name
    KW-0761
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
16
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Subjects who were properly monitored for DLTs were to be analyzed to determine the number of subjects with a DLT by dose level.
    measure
    Incidence of Dose-Limiting Toxicities (DLTs)
    time Frame
    28 days
  2. description
    The dose level at which Dose-Limiting Toxicity (DLT) was recognized was to be regarded as Maximum Tolerated Dose (MTD), and the dose level below MTD by one level was to be regarded as the recommended dose level (when MTD was not reached, 1.0 mg/kg was to be regarded as the recommended dose level) and 3 more subjects were to be newly added to the recommended dose level.
    measure
    Maximum Tolerated Dose (MTD)
    time Frame
    28 days
  3. description
    Plasma KW-0761 concentrations were to be summarized in tabular form with the descriptive statistics on a dose-by-dose basis. Individual and mean (+ standard deviation) plasma KW-0761 concentrations on an actual or logarithmic scale were to be plotted against the time of blood sampling.
    measure
    Pharmacokinetics-Plasma KW-0761 Concentrations
    time Frame
    0-7 days post final dose
  4. description
    The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.
    measure
    Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (AUC0-7 Days)
    time Frame
    0-7 days post final dose
  5. description
    The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.
    measure
    Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (t1/2)
    time Frame
    0 to 28 days post final dose and follow-up examinations (1 month and 2 months after the end of the post-dosing observation period).
secondary Outcomes
  1. description
    The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).
    measure
    Antitumor Effect
    time Frame
    50 days
  2. description
    TTP was defined as the period from the day starting the first KW-0761 dosing to the day of PD identification (or the day of death if the subject died before PD was documented). Subjects were to be censored at the time of starting post-treatment, if it was started before PD identification.
    measure
    Time to Progression (TTP)
    time Frame
    Baseline to response
Full study description
brief Summary
This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).
detailed Description
This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established.
Source references
references
  1. citation
    Ishida T, Ueda R. CCR4 as a novel molecular target for immunotherapy of cancer. Cancer Sci. 2006 Nov;97(11):1139-46. doi: 10.1111/j.1349-7006.2006.00307.x. Epub 2006 Sep 5.
    pmid
    16952304
    type
    BACKGROUND
  2. citation
    Yano H, Ishida T, Inagaki A, Ishii T, Ding J, Kusumoto S, Komatsu H, Iida S, Inagaki H, Ueda R. Defucosylated anti CC chemokine receptor 4 monoclonal antibody combined with immunomodulatory cytokines: a novel immunotherapy for aggressive/refractory Mycosis fungoides and Sezary syndrome. Clin Cancer Res. 2007 Nov 1;13(21):6494-500. doi: 10.1158/1078-0432.CCR-07-1324.
    pmid
    17975162
    type
    BACKGROUND
  3. citation
    Yano H, Ishida T, Inagaki A, Ishii T, Kusumoto S, Komatsu H, Iida S, Utsunomiya A, Ueda R. Regulatory T-cell function of adult T-cell leukemia/lymphoma cells. Int J Cancer. 2007 May 1;120(9):2052-7. doi: 10.1002/ijc.22536.
    pmid
    17278106
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
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        exact text
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice