Phase 2
N=27
Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
Adult T-cell Leukemia-lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00920790 ↗Enrolled (actual)
27
Serious AEs
22.2%
Results posted
Sep 2012
Primary outcome: Primary: Overall Response Rate (ORR) — 50 percentage of participants with response
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KW-0761 (Biological)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kyowa Kirin Co., Ltd.
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
50 | — |
| PRIMARY Pharmacokinetics-Plasma KW-0761 Concentrations |
42943.2; 33638.3 | — |
| PRIMARY Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days) |
6297408 | — |
| PRIMARY Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2) |
422 | — |
| SECONDARY Progression Free Survival (PFS) |
97 | — |
| SECONDARY Overall Survival (OS) |
176.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Positive for serum anti-HTLV-I antibody
- Acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past
- Positive for CCR4
- Relapsed subject after the response (CR, CRu or PR) in the last previous chemotherapy
- Received at least one prior chemotherapy
- 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
- PS of 0 to 2
- Negative for HBs antigen and for HBV-DNA by a real-time PCR
Exclusion Criteria
- A history of transplantation such as hematopoietic stem cells
- Positive for HCV antibody or HIV antibody
- Active multiple cancers at the time of starting this clinical study
- Previous history of allergic reactions after receiving antibody products
- Requiring continuous systemic treatment with a steroid
- Requiring such radiotherapy after starting this clinical study
- Treated with any investigational drug other than KW-0761 within three months
Data sourced from ClinicalTrials.gov (NCT00920790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.