A Study to Assess AFM13 in Patients With Hodgkin Lymphoma
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pharmacodynamically-Guided Dose Escalation Phase I Study to Assess the Safety of AFM13 (Recombinant Antibody Construct Against Human CD30 and CD16A) in Patients With Refractory and/or Relapsed Hodgkin Lymphoma|
- To determine the safety and tolerability of AFM13 monotherapy. [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]Measure occurrence of adverse events and monitor laboratory safety parameters. Immunogenicity of AFM13.
- To determine the OBD (Optimal Biological Dose) or MTD (Maximum Tolerated Dose) of AFM13 [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]
- To define the pharmacokinetic profile of AFM13. [ Time Frame: Length of study ] [ Designated as safety issue: No ]To test levels of AFM13 in blood samples and assess curve compared to dose of AFM13 administered.
- To analyse immunological markers of activity [ Time Frame: Length of study ] [ Designated as safety issue: No ]ADCC, NK cell, Complement and Cytokine levels in the serum will be measured at different time points to assess the level of activity resulting from administration of AFM13.
- To assess the immunogenicity of AFM13. [ Time Frame: length of study ] [ Designated as safety issue: Yes ]
- To assess the activity of AFM13 [ Time Frame: length of study ] [ Designated as safety issue: No ]To measure immunological activity useing biomarkers in the blood and to measure response of the disease in FDG-PET and CT scans.
|Study Start Date:||October 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
IV (intravenous) infusion, dose escalation
Drug: AFM 13
Cohort escalation then expansion phase design. Starting dose 0.01 mg/kg. 4 weekly drug administrations.
The overall objective of this study is to determine the safety, tolerability, pharmacokinetics and activity of single cycles of AFM13 in patients with CD30 positive refractory and/or relapsed Hodgkin lymphoma.
- To determine the safety and tolerability of increasing doses of single cycles of AFM13 monotherapy.
- To determine the OBD (Optimal Biological Dose) or MTD (Maximum Tolerated Dose) of AFM13; whichever is reached first.
- To define the pharmacokinetic profile of AFM13.
- To analyse immunological markers e.g. ADCC (Antibody dependent cell mediated cytotoxicity), NK (Natural killer) cell activity, complement activation and depletion, and cytokine release.
- To assess the immunogenicity of AFM13.
- To assess the activity of AFM13.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221571
|United States, Texas|
|The University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-2374|
|University Hosptial Cologne|
|Koln, Köln, Germany, 50924 Köln|
|University Hospital Würzburg|
|Würzburg, Germany, 97080|
|Principal Investigator:||Andreas Engert, Professor||University Hospital Cologne, Germany|
|Principal Investigator:||Anas Younes, Professor||MD Anderson Cancer Center, Houston, Texas|
|Principal Investigator:||Max S Topp, Professor||University Hospital Würzburg, Germany|