Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma

Phase 2

Completed

• Conditions: Adult T-cell Leukemia-lymphoma
• Interventions: Biological: KW-0761

• Registration Number: NCT00920790
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

To evaluate the efficacy, safety and pharmacokinetic profiles of KW-0761, the anti-CC chemokine receptor 4 (CCR4) antibody, when administered weekly for 8 weeks as an intravenous infusion at a dose of 1.0 mg/kg in relapsed subjects with CCR4-positive adult T-cell leukemia-lymphoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Primary Completion: 2010-07
• Study Completion: 2010-11
• Results First Submitted: 2012-07-09
• Results First Submitted QC: 2012-08-24
• Results First Posted: 2012-09-25
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Positive for serum anti-HTLV-I antibody
2. Acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past
3. Positive for CCR4
4. Relapsed subject after the response (CR, CRu or PR) in the last previous chemotherapy
5. Received at least one prior chemotherapy
6. Subjects with an interval of four weeks or more between the last day of the previous treatment and the scheduled day of the first KW-0761 treatment
7. PS of 0 to 2
8. Negative for HBs antigen and for HBV-DNA by a real-time PCR

Exclusion Criteria

1. A history of transplantation such as hematopoietic stem cells
2. Positive for HCV antibody or HIV antibody
3. Active multiple cancers at the time of starting this clinical study
4. Previous history of allergic reactions after receiving antibody products
5. Requiring continuous systemic treatment with a steroid
6. Requiring such radiotherapy after starting this clinical study
7. Treated with any investigational drug other than KW-0761 within three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KW-0761	KW-0761	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics-Plasma KW-0761 Concentrations	0 to 7 days post final dose	Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.; The baseline and maximum time point at which Cmax and Ctrough were collected are 0 to 7 days post-dose.
Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)	0 to 7 days post final dose	Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.
Overall Response Rate (ORR)	From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months.	Response rate defined as the proportion of responders relative to the total population and its exact 95% confidence interval were calculated for best overall response.; 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).Overall Response (OR)= CR + PR.
Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)	0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period).

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Baseline to response	The time from the date of first KW-0761 dosing to the date of death.
Progression Free Survival (PFS)	Baseline to response	The time from the date of first KW-0761 dosing to the date of progressive disease(PD) confirmation or death.; The antitumor response criteria including 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).