Patients who were on the placebo arm and experienced progression of HL while participating in the SGN35-005 clinical study MedDRA version: 12.1 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma
Conditions
Sponsors
Seattle Genetics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who met all inclusion/exclusion criteria for and participated in the SGN35-005 clinical study. 2. Patients who were treated with placebo in the SGN35-005 clinical study after autologous hematopoietic stem cell transplantation (ASCT) and experienced progression of HL based on the Revised Response Criteria for Malignant Lymphoma (Cheson 2007) as defined by protocol in study SGN35-005. 3. Age greater than or equal to 18 years. 4. An Eastern Cooperative Oncology Group (ECOG) performance status =2. 5. Patients must have completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of SGN-35. 6. 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 brentuximab vedotin. Females of non-childbearing potential are those who are postmenopausal for more than 1 year or who have had a bilateral tubal ligation or hysterectomy. 7. 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. 8. The following baseline laboratory values are required: absolute neutrophil count (ANC) =1000/µL, platelets =50,000/µL, bilirubin =1.5 x upper limit of normal (ULN) or =3 x ULN for patients with Gilbert’s disease, serum creatinine =1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 x ULN. 9. 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: 1. Any Grade 3 viral, bacterial, or fungal infection requiring treatment with therapy within 1 week prior to the first study dose. 2. Patients with = Grade 2 peripheral neuropathy. 3. 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, fully excised melanoma in situ [Stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.) 4. Known cerebral/meningeal disease. 5. Current therapy with other systemic anti-neoplastic or investigational agents. 6. Women who are pregnant or lactating. 7. Patients with a known hypersensitivity to any excipient contained in the drug formulation. 8. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent. 9. Patients who are eligible for participation in other clinical studies of brentuximab vedotin at their institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To provide the option of treatment with brentuximab vedotin for those patients on the placebo arm in study SGN35-005 who experience progression of Hodgkin lymphoma (HL) • To assess the safety and tolerability of brentuximab vedotin;Secondary Objective: N/A;Primary end point(s): The safety endpoints are the type, incidence, severity, seriousness, and study drug relatedness of adverse events (AEs). | — |
Countries
Belgium, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed