Phase II study of KW-0761

Phase II study of KW-0761 in subjects with CCR4-positive adult T-cell leukemia-lymphoma

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220744

Enrollment

Registered

2009-06-09

Start date

2009-06-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult T-cell leukemia-lymphoma

Interventions

investigational material(s) Generic name etc : KW-0761 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

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: Only after 4 weeks had elapsed since the most recent treatment 4 weeks 7: PS of 0 to 2 8: Negative for HBs antigen and for HBV-DNA by a real-time PCR

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Efficacy (Best response in each legion), Progression free survival (PFS), Overall survival (OS), Pharmacokinetics of KW-0761, Safety, Immunogenicity The best response in the peripheral blood and the lesions other than peripheral blood in the lesions are determined in accordance with the applicable criteria. A subject diagnosed as having CR, CRu or PR in each lesion is considered a response. Progression free survival (PFS) is defined as the period from the day of starting the first KW-0761 dosing to the day of progressive disease (PD) identification or the day of death if the subject dies before PD is documented. Overall survival (OS) is defined as the period from the day of starting the first KW-0761 dosing to the day of death.	—

Measure

Time frame

Efficacy (Best response in each legion), Progression free survival (PFS), Overall survival (OS), Pharmacokinetics of KW-0761, Safety, Immunogenicity The best response in the peripheral blood and the lesions other than peripheral blood in the lesions are determined in accordance with the applicable criteria. A subject diagnosed as having CR, CRu or PR in each lesion is considered a response. Progression free survival (PFS) is defined as the period from the day of starting the first KW-0761 dosing to the day of progressive disease (PD) identification or the day of death if the subject dies before PD is documented. Overall survival (OS) is defined as the period from the day of starting the first KW-0761 dosing to the day of death.

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Primary

Measure	Time frame
Efficacy (Best Response) A subject diagnosed as having complete response (CR), CR/unconfirmed (CRu) or partial response (PR) in the best overall response is considered a responder in accordance with the applicable criteria.	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026