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

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Adult T-cell Leukemia-lymphoma

Treatments: Biological: KW-0761

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920790

0761-002

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

KW-0761

Experimental group

Treatment:

Biological: KW-0761