A Study to Assess AFM13 in Patients With Hodgkin Lymphoma
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|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|
|Actual Primary Completion Date :||May 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|