None listed
Conditions
Interventions
Treatment can be administered on an outpatient basis. Subjects will receive 1.0 mg/kg of KW-0761 as an iv infusion over at least 1 hour on Days 1, 8, 15 and 22 of the first cycle and on Days 1 and 15
Sponsors
Kyowa Hakko Kirin Pharma, Incorporated,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Subject must meet the following criteria for inclusion in this study; Signed Written Informed Consent 1) Voluntarily signed and dated Institutional Review Board (IRB)/ Ethics Committee (EC) approved informed consent form in accordance with regulatory and institutional guidelines. Written informed consent must be obtained prior to performing any study-related procedure; Age and Sex 2) Males and female subjects  18 years of age at the time of enrollment; Target Population 3) Confirmed diagnosis of ATL, excluding smoldering subtype18 (see Appendix 1): a. Subjects must have been determined to be positive for HTLV-1 virus b. Subjects must have hematologically or pathohistologically diagnosed peripheral lymphoid tissue which surface antigen analysis has identified to be of T-cell origin 4) Subjects must currently have evidence of disease in at least one of the following: a. Lymph nodes b. Extranodal masses c. Spleen or liver d. Skin e. Peripheral blood f. Bone marrow 5) Relapsed or refractory after at least one prior systemic therapy regimen for ATL; 6) Eastern Cooperative Oncology Group (ECOG) performance status score47 of ≤ 2 at study entry (Appendix 2); 7) The subject has resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0) excluding the specifications required in 8, 9 and 10 below; 8) Adequate hematological function: a. absolute neutrophil count (ANC) ≥ 1,000/mm3; b. platelets ≥ 50,000 / mm3 c. If ANC and/or platelet count is less than the level specified above in the setting of documented bone marrow involvement, investigator may discuss individual case with the Medical Monitor, who will determine if subject may be enrolled Note: Retesting for values out of criteria will be permitted. Subjects being recruited to this study will not necessarily meet the inclusion/exclusion criteria for baseline organ function, for all the comparators due to the leukemic nature of their illness and bone marrow involvement by the neoplastic process; this should be taken into account by the investigator and if necessary discussed with the medical monitor. 9) Adequate hepatic function: a. bilirubin ≤ 2 times the specific institutional ULN; b. aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN or ≤ 5.0 x ULN in the presence of known hepatic ATL involvement. Note: Retesting for values out of criteria will be permitted 10) Adequate renal function: a. serum creatinine 60 mL/min (or > 30 mL/min with documented renal infiltration); Note: Retesting for values out of criteria will be permitted 11) Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication and prior to each treatment cycle; 12) WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true abstinence from sexual intercourse* (periodic abstinence ,e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 6 mon
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects with any of the following will be excluded from the study; Medical History and Concurrent Diseases 1) Smoldering subtype of ATL 2) History of allogeneic transplant; 3) Autologous hematopoietic stem cell transplant within 90 days of study entry; 4) Untreated human immunodeficiency virus (HIV). Patients on HIV therapy with undetectable viral loads as measured by HIV RNA quantitative real time PCR may be enrolled; 5) Has known or tests positive for hepatitis C; 6) Has known or tests positive for hepatitis B. Patients who are negative on qualitative HBV DNA assay may be enrolled; 7) Have had a malignancy in the past two years. However, subjects with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current PSA of 160 mm Hg or diastolic BP 100 mmHg, found on two consecutive measurements separated by a 1-week period) despite two anti-hypertensive medications; f. clinically significant cardiac arrhythmia; or g. uncontrolled diabetes. 11) Subjects with a history of moderate or severe psoriasis or with psoriasis associated with systemic symptoms e.g. arthropathy, or with a 1st degree relative with history of psoriasis that required systemic medical intervention. 12) Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins; 13) Any contra-indication to any of the comparators (gemcitabine, oxaliplatin, cytarabine, cisplatin and dexamethasone) according to local SmPCs/Prescribing Information would preclude treatment with that option; 14) Known active autoimmune disease will be excluded (For example; Grave’s disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn’s disease); 15) Is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating. Prohibited Therapies and/or Medications 16) Prior treatment with KW-0761; 17) Initiation of treatment with systemic corticosteroids while on study is only permitted for acute and brief complications of underlying disease (e.g., hypercalcemia) or for treatment related side effects (e.g., including pre-medication for infusion reaction, nausea and vomiting). Subjects on systemic corticosteroids prior to enrollment must be off for 7 days before initiation of study treatment, unless specifically indicated for the treatment of hypercalcemia. However, once the calcium returns to normal and the subject is
Countries
Australia, Belgium, Brazil, France, India, Panama, United Kindgdom, United States
Contacts
Public ContactRAUL JAVIER YEPEZ
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed