A Study to Assess AFM13 in Patients With Hodgkin Lymphoma

Inclusion Criteria

• •1. Histological diagnosis of relapsed or refractory Hodgkin lymphoma expressing the CD30 antigen.
• •2. Age ≥18 years.
• •3. Both genders.
• •4. 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.
• •5. Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry.
• •6. Patients who received ASCT should have fully recovered prior to study entry.
• •7. Eastern Cooperative Oncology Group (ECOG) status of ≤2.
• •8. Laboratory data:
• •1. Platelet count \>75,000/mm3;
• •2. Hemoglobin \>9.0 g/dL (may be maintained by transfusion);
• •3. Absolute neutrophil count \>1500/mm3;
• •4. ALT/AST (Alanine aminotransferase/Aspartate aminotransferase)\<2.5 times the upper limit of normal (ULN);
• •5. Total bilirubin \<1.5 times ULN;
• •6. Creatinine \<1.5 mg/dL.
• •9. 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.
• •10. 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informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
• •11. Be willing and able to comply with the study protocol for the duration of the study.