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

Adult T-cell Leukemia-lymphoma Clinical Trial

Official title:

Phase II Clinical Study of KW-0761 in Patients With CCR4-Positive Adult T-cell Leukemia-Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920790
• Other study ID #: 0761-002
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2009
• Last updated: August 24, 2012
• Start date: June 2009
• Est. completion date: November 2010

Study information

• Verified date: August 2012
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult T-cell Leukemia-lymphoma
• Leukemia
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma

Intervention

Biological:
• KW-0761
KW-0761 is administered weekly for 8 weeks as an intravenous infusion of 2 hours at a dose of 1.0 mg/kg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Ishida T, Joh T, Uike N, Yamamoto K, Utsunomiya A, Yoshida S, Saburi Y, Miyamoto T, Takemoto S, Suzushima H, Tsukasaki K, Nosaka K, Fujiwara H, Ishitsuka K, Inagaki H, Ogura M, Akinaga S, Tomonaga M, Tobinai K, Ueda R. Defucosylated anti-CCR4 monoclonal a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	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.	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.	No
Primary	Pharmacokinetics-Plasma KW-0761 Concentrations	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.	0 to 7 days post final dose	No
Primary	Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)	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.	0 to 7 days post final dose	No
Primary	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).	No
Secondary	Progression Free Survival (PFS)	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).	Baseline to response	No
Secondary	Overall Survival (OS)	The time from the date of first KW-0761 dosing to the date of death.	Baseline to response	No