A Study to Assess AFM13 in Patients With Hodgkin Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Affimed Therapeutics AG.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Affimed Therapeutics AG
First received: October 5, 2010
Last updated: June 15, 2012
Last verified: February 2011
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.
Drug: AFM 13
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2012 (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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histological diagnosis of relapsed or refractory Hodgkin lymphoma expressing the CD30 antigen.
- Age ≥18 years.
- Both genders.
- Patients who have relapsed or are refractory after at least two prior potentially curative therapies including autologous stem cell transplantation (ASCT). Patients with a progressive disease after the first-line therapy who are ineligible for, or refused to receive high dose chemotherapy and/or ASCT for the second-line therapy, or any other established curative therapy, are also eligible.
- Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry.
- Patients who received ASCT should have fully recovered prior to study entry.
- Eastern Cooperative Oncology Group (ECOG) status of ≤2.
- Platelet count >75,000/mm3;
- Hemoglobin >9.0 g/dL (may be maintained by transfusion);
- Absolute neutrophil count >1500/mm3;
- ALT/AST (Alanine aminotransferase/Aspartate aminotransferase)<2.5 times the upper limit of normal (ULN);
- Total bilirubin <1.5 times ULN;
- Creatinine <1.5 mg/dL.
- Female patients of childbearing potential who are not surgically sterile or postmenopausal and male patients who are not surgically sterile must agree to use medically effective contraception during the treatment period and up to 60 days after the last AFM13 administration. The patient must agree to sign his or her consent on this particular inclusion criterion.
- Ability to give written, informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
- Be willing and able to comply with the study protocol for the duration of the study.
- Any significant diseases (other than HL (Hodgkin Lymphoma)) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the patient from participating in the study.
- History or clinical evidence of central nervous system (CNS) HL.
- Allogeneic SCT.
- Major surgery within 4 weeks prior to study entry.
- Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
- Known history of another primary malignancy that has not been in remission for at least 5 years. Non-concurrent non-melanoma skin cancer and cervical carcinoma in situ or squamous intraepithelial lesions (e.g., cervical intraepithelial neoplasia [CIN] or prostatic intraepithelial/intraductal neoplasia [PIN]) are allowed.
- Any active viral, bacterial, or systemic fungal infection within 4 weeks prior to study entry.
- Known to be positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).
- History of significant chronic or recurrent infections requiring treatment.
- Receiving systemic steroid prednisone or equivalent during the 3 weeks immediately preceding enrollment.
- Pregnant or breast-feeding.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221571
|The University of Texas MD Anderson Cancer Center
|Houston, Texas, United States, 77030-2374 |
|Contact: Anas Younes, MD 713-792-2860 email@example.com |
|Principal Investigator: Anas Younes, Professor MD |
|University Hosptial Cologne
|Koln, Köln, Germany, 50924 Köln |
|Contact: Andreas Engert, Prof. Dr. +49 (221) 478-5933 ext 5966 firstname.lastname@example.org |
|Principal Investigator: Andreas Engert, Professor MD |
|University Hospital Würzburg
|Würzburg, Germany, 97080 |
|Contact: Max S Topp, Professor +49 (931) 201 40917 Topp_M@medizin.uni-wuerzburg.de |
|Principal Investigator: Max S Topp, Professor MD |
Affimed Therapeutics AG
||Andreas Engert, Professor
||University Hospital Cologne, Germany
||Anas Younes, Professor
||MD Anderson Cancer Center, Houston, Texas
||Max S Topp, Professor
||University Hospital Würzburg, Germany
No publications provided by Affimed Therapeutics AG
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Reiners KS, Kessler J, Sauer M, Rothe A, Hansen HP, Reusch U, Hucke C, Köhl U, Dürkop H, Engert A, von Strandmann EP. Rescue of impaired NK cell activity in hodgkin lymphoma with bispecific antibodies in vitro and in patients. Mol Ther. 2013 Apr;21(4):895-903. doi: 10.1038/mt.2013.14. Epub 2013 Mar 5.
||Affimed Therapeutics AG
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 5, 2010
||June 15, 2012
||United States: Food and Drug Administration
Keywords provided by Affimed Therapeutics AG:
Natural killer cell
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Neoplasms by Histologic Type
Immune System Diseases