Status:
COMPLETED
A Study to Assess AFM13 in Patients With Hodgkin Lymphoma
Lead Sponsor:
Affimed GmbH
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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/o...
Eligibility Criteria
Inclusion
- 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.
- Laboratory data:
- 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informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01221571
Start Date
October 1 2010
End Date
June 1 2013
Last Update
June 26 2013
Active Locations (3)
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1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-2374
2
University Hosptial Cologne
Cologne, Köln, Germany, 50924 Köln
3
University Hospital Würzburg
Würzburg, Germany, 97080