NCT00355472

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

September 7, 2012

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

July 20, 2006

Results QC Date

August 7, 2012

Last Update Submit

October 17, 2012

Conditions

Adult T-Cell Leukemia and Lymphoma (ATL)Adult Peripheral T-Cell Lymphoma (PTCL)

Keywords

Adult T-Cell LeukemiaATLAdult Peripheral T-Cell LymphomaPTCL

Outcome Measures

Primary Outcomes (5)

  • Incidence of Dose-Limiting Toxicities (DLTs)

    Subjects who were properly monitored for DLTs were to be analyzed to determine the number of subjects with a DLT by dose level.

    28 days

  • Maximum Tolerated Dose (MTD)

    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.

    28 days

  • Pharmacokinetics-Plasma KW-0761 Concentrations

    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.

    0-7 days post final dose

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

    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.

    0-7 days post final dose

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

    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.

    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 (2)

  • Antitumor Effect

    50 days

  • Time to Progression (TTP)

    Baseline to response

Study Arms (1)

1

EXPERIMENTAL

KW-0761

Drug: KW-0761

Interventions

KW-0761DRUG

IV administration at 4 escalating dose levels.

1

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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;
  • : Relapsed to the latest standard chemotherapy;
  • : Received at least one prior chemotherapy;
  • : After 4 weeks from a prior therapy;
  • : Have measurable disease;
  • :Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
  • : Male or female, at least 20 years and not older than 70 years of age;
  • : Signed written informed consent;
  • : Stay in hospital for 4 weeks;
  • : HBs antigen: negative, HBV-DNA: below the limit of quantification (within 14 days before the study entry);
  • +11 more criteria

You may not qualify if:

  • 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;
  • Active tuberculosis;
  • Prior stem cell transplantation;
  • Myocardial infarction (within 12 months prior to the study entry);
  • Concurrent acute or chronic hepatitis, or cirrhosis;
  • Anti-HCV: positive, Anti-HIV: positive
  • Concurrent active malignant disease;
  • Known allergic reaction to antibody therapy;
  • Concomitant treatment with systemic steroids;
  • Prior and Concurrent psychiatric disorder including dementia, epilepsy or any other CNS diseases;
  • Evidence of CNS metastasis at baseline;
  • Prior and Concurrent spinal cord disease;
  • Radiation therapy for bulky mass disease at the time of study entry or considered to require radiation therapy during the study;
  • Female patients who are pregnant or breast feeding;
  • Female patients of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with the institution's standards;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Related Publications (3)

  • 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: 16952304BACKGROUND

  • 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: 17975162BACKGROUND

  • 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: 17278106BACKGROUND

MeSH Terms

Conditions

Leukemia-Lymphoma, Adult T-CellLymphoma, T-Cell, Peripheral

Interventions

mogamulizumab

Condition Hierarchy (Ancestors)

Leukemia, T-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-HodgkinLymphoma

Results Point of Contact

Title
Project Management Department, Development Division
Organization
Kyowa Hakko Kirin
clinical.info@kyowa-kirin.co.jp

Study Officials

  • Study Director

    Kyowa Kirin Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2006

First Posted

July 24, 2006

Study Start

February 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 18, 2012

Results First Posted

September 7, 2012

Record last verified: 2012-10

Locations

JP(1)