A Phase 1 interventional study of AFM 13 in Hodgkin Lymphoma, sponsored by Affimed GmbH. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-26.
Sponsored by Affimed GmbH · Phase 1, Interventional, and Treatment
The aim 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.
Study Objectives:
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.
Objectives:
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Affimed GmbH is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Laboratory data:
Exclusion Criteria:
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.
Measure occurrence of adverse events and monitor laboratory safety parameters. Immunogenicity of AFM13.
Time frame: Length of Study
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.
To test levels of AFM13 in blood samples and assess curve compared to dose of AFM13 administered.
Time frame: Length of study
To analyse immunological markers of activity
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.
Time frame: Length of study
To assess the immunogenicity of AFM13.
Time frame: length of study
To assess the activity of AFM13
To measure immunological activity useing biomarkers in the blood and to measure response of the disease in FDG-PET and CT scans.
Time frame: length of study
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Affimed GmbH