Clinical trial NCT00920790: Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
Official title: Phase II Clinical Study of KW-0761 in Patients With CCR4-Positive Adult T-cell Leukemia-Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult T-cell Leukemia-lymphoma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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. 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 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.
measure: Pharmacokinetics-Plasma KW-0761 Concentrations
timeFrame: 0 to 7 days post final dose
measure: Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)
timeFrame: 0 to 7 days post final dose
measure: Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)
timeFrame: 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 outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline to response
measure: Overall Survival (OS)
timeFrame: Baseline to response
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
citation: 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 antibody (KW-0761) for relapsed adult T-cell leukemia-lymphoma: a multicenter phase II study. J Clin Oncol. 2012 Mar 10;30(8):837-42. doi: 10.1200/JCO.2011.37.3472. Epub 2012 Feb 6.