| Inclusion Criteria: | 1) Patients with relapsed or refractory systemic ALCL who have previously received front-line chemotherapy (CHOP or multi-agent chemotherapy regimens with curative intent).
2) Documented anaplastic lymphoma kinase (ALK) status.
3) Histologically-confirmed CD30-positive disease; tissue from the most recent post-diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block. If such tissue is not available, a fresh biopsy must be obtained.
4) Age greater than or equal to 18 years. - Patients of age greater than or equal to 12 years may be enrolled at US and Canadian sites.
5) Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography (PET) and spiral computed tomography(CT).
6) At least ONE of the following as evidence of relapsed or refractory systemic ALCL: a) Histologically-documented CD30-positive systemic ALCL from a biopsy obtained at least 4 weeks subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents.b) Interval tumor growth documented between two successive CT evaluations with the second evaluation occurring at least 4 weeks after delivery of any radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents.
7) Continuation #6) c) FDG-avidity by PET in a new tumor mass on CT that is unlikely to have an alternative explanation. d) Recurrent FDG-avidity by PET in a previously identified FDG-avid tumor mass on CT that had become negative. e) FDG-avid tumor mass by PET in conjunction with systemic ALCL related symptoms (e.g., pruritus, B symptoms (fever, night sweats, or weight loss >10%)), after infectious causes have been excluded.
8) Received any previous ASCT at least 12 weeks (3 months) prior to the first study dose.Completed any previous treatment with radiation, chemotherapy, biologics, and/or other investigational agents at least 4 weeks prior to the first dose of SGN-35, unless progressing on therapy. Patients must have completed any prior immunotherapy (e.g., monoclonal antibody) or radioisotopic therapy at least 12 weeks prior to the first dose of SGN-35, unless progressing on therapy.
9) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
10) The following required baseline laboratory data: absolute neutrophil count (ANC) >/= 1000/microL, platelets >/= 50,000/microL (unless documented bone marrow involvement with lymphoma), bilirubin </= 1.5X upper limit of normal (ULN) or </= 3X ULN for patients with Gilbert's disease or documented hepatic involvement with lymphoma, serum creatinine </= 1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </=2.5X ULN.
11) Females of childbearing potential must have a negative serum or urine Beta -hCG pregnancy test result within 7 days prior to the first dose of SGN-35. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
12) Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug.
13) Patients or their legally authorized representative must provide written informed consent. |