Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Leukemia

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Leukemia, T-Cell

Leukemia-Lymphoma, Adult T-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphoma, Non-Hodgkin

Leukemia, Lymphoid

Lymphosarcoma

Peripheral T-cell Lymphoma

Adult T-cell Leukemia/lymphoma

Leukemia, T-cell, Chronic

Antineoplastic Agents

All Drugs and Chemicals

Mogamulizumab

IV administration at 4 escalating dose levels.

KW-0761

Study Director

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).

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.

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

Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL)

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

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.

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.

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.

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).

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.

Kyowa Kirin Co., Ltd.

IV infusions of KW-0761 once/week for 4 weeks

KW-0761 0.01mg

KW-0761 0.1mg

KW-0761 0.5mg

KW-0761 1.0mg

KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL

Age Continuous

Sex: Female, Male

PTCL

Diagnosis

Project Management Department, Development Division

Incidence of Dose-Limiting Toxicities (DLTs)

Maximum Tolerated Dose (MTD)

Complete Response (CR)

Uncertain Complete Response (CRu)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

Not Evaluable (NE)

Antitumor Effect

Cmax

Ctrough

Pharmacokinetics-Plasma KW-0761 Concentrations

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

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

KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL.

Time to Progression (TTP)

KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CC chemokine 4 receptor (CCR4) positive Adult T-Cell Leukemia-Lymphoma (ATL) or CCR4 positive Peripheral T-Cell Lymphoma (PTCL)

Overall Study

Spots Global Cancer Trial Database for Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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