Relapsed or refractory Hodgkin Lymphoma (HL) MedDRA version: 9.1 Level: PT Classification code 10020206 Term: Hodgkin's disease
Conditions
Interventions
Product Name: SGN-35
Product Code: SGN-35
Pharmaceutical Form: Powder for concentrate for solution for infusion
CAS Number: 914088-09-8
Current Sponsor code: SGN-35
Other descriptive name: cAC10-VC-SG
Sponsors
Seattle Genetics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for this study, patients must meet ALL of the following inclusion criteria: 1. Patients with relapsed or refractory HL who have previously received ASCT. Patients must have received prior ASCT at least 12 weeks (3 months) before the first dose of SGN-35 and completed any prior treatment with radiation, chemotherapy, biologics, and/or other investigational agents at least 4 weeks prior to the first dose of SGN-35. Patients must have completed any prior immunotherapy (e.g., rituximab) or radioisotopic therapy at least 12 weeks prior to the first dose of SGN-35 in the absence of clear disease progression. 2. Histologically-confirmed CD30-positive disease by central review; 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. See Section 7.4 of the protocol for details. 3. Age greater than or equal to 18 years. 4. Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by spiral CT, as assessed by the site radiologist. 5. At least ONE of the following as evidence of relapsed or refractory HL: a) Histologically-documented CD30-positive HL 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 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 HL related symptoms (e.g., pruritus, B symptoms (fever, night sweats, or weight loss >10%)), after infectious causes have been excluded. 6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. The following required baseline laboratory data: absolute neutrophil count (ANC) =1000/µL, platelets =50,000/µL, bilirubin =1.5X upper limit of normal (ULN) or =3X ULN for patients with Gilbert’s disease, serum creatinine =1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5X ULN. 8. Females of childbearing potential must have a negative serum or urine ß-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. 9. 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. 10. Patients or their legally authorized representative must provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: If a patient is positive for any of the following exclusion criteria, the patient will not be eligible for this study: 1. Previous treatment with SGN-35. 2. Previously received an allogeneic transplant. 3. Congestive heart failure, Class III or IV, by the NYHA criteria. 4. History of another primary malignancy that has not been in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.) 5. Known cerebral/meningeal disease. 6. Any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of SGN-35. 7. Current therapy with other systemic anti-neoplastic or investigational agents. 8. Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of SGN-35. 9. Women who are pregnant or lactating. 10. Patients with a known hypersensitivity to any excipient contained in the drug formulation. 11. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the antitumor efficacy of single-agent SGN-35 (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory Hodgkin lymphoma following autologous stem cell transplant;Secondary Objective: The secondary objectives of this study are the following: • To assess duration of tumor control, including duration of response and progression-free survival (PFS) • To assess survival • To assess the safety and tolerability of SGN-35 • To assess the pharmacokinetics of SGN-35 Furthermore, additional objectives are the following: • To assess disease-related symptoms • To explore the correlation of potential biomarkers with clinical outcomes;Primary end point(s): The primary endpoint of this study is the overall objective response rate (ORR) per an independent review facility (IRF). | — |
Countries
Belgium, France, Germany, Italy, United Kingdom
Outcome results
None listed