A Study to Assess AFM13 in Patients With Hodgkin Lymphoma
|ClinicalTrials.gov Identifier: NCT01221571|
Recruitment Status : Completed
First Posted : October 15, 2010
Last Update Posted : June 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: AFM 13||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2010|
|Primary Completion Date :||May 2013|
|Study Completion Date :||June 2013|
IV (intravenous) infusion, dose escalation
Drug: AFM 13
Cohort escalation then expansion phase design. Starting dose 0.01 mg/kg. 4 weekly drug administrations.
- To determine the safety and tolerability of AFM13 monotherapy. [ Time Frame: Length of Study ]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 ]
- To define the pharmacokinetic profile of AFM13. [ Time Frame: Length of study ]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 ]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 ]
- To assess the activity of AFM13 [ Time Frame: length of study ]To measure immunological activity useing biomarkers in the blood and to measure response of the disease in FDG-PET and CT scans.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|