A Phase 2 open label trial of SGN-35 for systemic anaplastic large cell lymphoma
- Conditions
- Systemic anaplastic large cell lymphoma (ALCL)MedDRA version: 14.1Level: LLTClassification code 10065864Term: Anaplastic large-cell lymphoma, primary systemic typeSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-006035-12-BE
- Lead Sponsor
- Seattle Genetics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
• 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>• To assess duration of tumor control, including duration of response and progression-free survival (PFS)<br>• To assess survival<br>• To assess the safety and tolerability of SGN-35<br>• To assess the pharmacokinetics of SGN-35<br>;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 Outcome Measures
Name Time Method Secondary end point(s): The secondary endpoints are:<br>• Duration of response per IRF<br>• Complete remission (CR) rate per IRF<br>• Progression-free survival (PFS) per IRF<br>• Overall survival (OS)<br>• Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory<br>abnormalities<br>• 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<br>• Complete remission (CR) rate per IRF: Every 2 to 3 months<br>• Incidence of adverse events and laboratory abnormalities: Through 1 month following last dose <br>• Population estimates of selected pharmacokinetic parameters: Every 2-3 weeks<br>