Open-Label, Multi-Center, Dose Escalation Phase 1/2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects With Previously Treated Peripheral T-Cell Lymphoma
This study will determine the maximum dose of KW-0761 administered intravenously that can be given safely in subjects with previously treated peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma(CTCL)and will see if it is effective in treating the disease.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- biological : KW-0761
Phase: Phase 1/Phase 2
Ages Eligible For Study:
1. histologically/cytologically confirmed diagnosis of PTCL including CTCL (including MF and SS) but excluding ATLL. 2. failed at least one prior systemic therapy for PTCL or CTCL. 3. ECOG PS of <=2 at study entry. 4. >=18 years of age. 5. completed any prior therapy at least four weeks prior to entry; however, patients with rapidly progressive malignant disease may be enrolled prior to this period after discussion with the medical monitor. 6. resolution of all clinically significant toxic effects of prior cancer therapy to grade ?1 by the NCI-CTCAE, v.3.0 excluding the specifications required in 7 and 8 below. 7. adequate hematological function: absolute neutrophil count>=1,500 cells/uL and platelets >=100,000 cells/uL except in patients with known bone marrow involvement where absolute neutrophil count must be >=1,000 cells/uL and platelets >=75,000 cells/uL. 8. adequate hepatic function: bilirubin ? 1.5 times the specific institutional ULN; aspartate transaminase and alanine transaminase each ? 2.5 x ULN or ? 5.0 x ULN in the presence of known hepatic malignancy. 9. serum creatinine ?1.5 x ULN or a calculated creatinine clearance >60 mL/min. 10. CTCL subjects previously treated with zanolimumab are eligible provided their CD4+ cell counts have recovered to pre-treatment levels. 11. Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics. 12. provided signed informed consent. 13. WOCBP must have a negative pregnancy test within 7 days of receiving study medication. 14. WOCBP must agree to use effective contraception 15. Male subjects must be willing to use an appropriate method of contraception (e.g., condoms) or abstain from sexual intercourse and inform any sexual partners that they must also use a reliable method of contraception during the study.