Patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT). 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 with HL who have received ASCT in the previous 30–45 days. 2. Patients at high risk of residual HL post ASCT as indicated by at least one of the following: • History of refractory HL (defined as patients progressing on or failing to achieve a complete remission following frontline standard chemotherapy (6 to 8 cycles) or a combined modality treatment program) • Relapsed or progressive HL that occurs =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous treatment with SGN-35. 2. Previously received an allogeneic transplant. 3. Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT. 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, 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.) 5. Known cerebral/meningeal disease. 6. Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first study dose. 7. Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents. 8. Women who are pregnant or lactating. 9. Patients with a known hypersensitivity to any excipient contained in the drug formulation. 10. 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 compare the progression-free survival (PFS) of SGN-35 and best supportive care (BSC) versus placebo and BSC.;Secondary Objective: The secondary objectives are: • To compare overall survival (OS) between the 2 treatment arms • To evaluate the safety and tolerability of SGN-35 compared to placebo • To characterize the incidence of anti-therapeutic antibodies (ATA);Primary end point(s): The primary efficacy endpoint of this study is progression-free survival (PFS) per an independent review facility (IRF). | — |
Countries
Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed