Systemic anaplastic large cell lymphoma (ALCL) MedDRA version: 14.1 Level: LLT Classification code 10065864 Term: Anaplastic large-cell lymphoma, primary systemic type System Organ Class: 100000004864
Conditions
Interventions
Product Name: brentuximab vedotin
Product Code: SGN-35
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: brentuximab vedotin
CAS Number: 914088-09-8
Current Sp
Sponsors
Seattle Genetics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with relapsed or refractory systemic ALCL (anaplastic large cell lymphoma) who have previously received front line chemotherapy. • Documented anaplastic lymphoma kinase (ALK) status. • 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. • Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT. • Received any previous ASCT (autologous stem cell transplant) at least 12 weeks (3 months) prior. • At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age Are the trial subjects under 18? yes Number of subjects for this age range: 4 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: • Previous treatment with SGN-35. • Previously received an allogeneic transplant. • Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible). • Known cerebral/meningeal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial 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 systemic anaplastic large cell lymphoma following front-line chemotherapy (CHOP or equivalent).;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 ;Primary end point(s): The primary endpoint of this study is the overall objective response rate (ORR) per an independent review facility (IRF).;Timepoint(s) of evaluation of this end point: Every 2 to 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • Duration of response per IRF • Complete remission (CR) rate per IRF • Progression-free survival (PFS) per IRF • Overall survival (OS) • Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities • Population estimates of selected pharmacokinetic parameters;Timepoint(s) of evaluation of this end point: • Duration of response, progression-free survival, and overall survival: Every 3 months until death or study closure • Complete remission (CR) rate per IRF: Every 2 to 3 months • Incidence of adverse events and laboratory abnormalities: Through 1 month following last dose • Population estimates of selected pharmacokinetic parameters: Every 2-3 weeks | — |
Countries
Belgium, Canada, France, Germany, Italy, United Kingdom, United States
Contacts
Public ContactClinical Operations
AMS Advanced Medical Services
Outcome results
None listed