Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The study is designed
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Any significant diseases (other than HL) or clinically significant findings including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the subject from participation in the study such as
Major organ dysfunction (except for HL-related reduced values e.g. in case of bone marrow or organ infiltration) as indicated by
History of a previous malignancy ≤3 years prior to first dose of study drug except basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or completely resected melanoma in stage TNMpT1
Patients with a history of HIV seropositivity, chronic active hepatitis, or another uncontrolled active infection within 4 weeks prior to first dose of study drug
Patients with evidence of current central nervous system (CNS) involvement
Prior allogeneic stem cell transplantation (SCT)
Patients receiving systemic corticosteroid treatment > 10 mg daily prednisone equivalents or other chronic systemic immunosuppressive agents within 2 weeks prior to first dose of study drug or during study treatment
Major surgery within 4 weeks prior to first dose of study drug
Known hypersensitivity to recombinant proteins or any excipient in the drug formulation
General intolerance of any protocol medication including obligatory concomitant medication
Pregnant or nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter. Male patients not willing to ensure that during the study and at least 3 months thereafter no fathering takes place
Patient´s lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
Patients unwilling to comply with the protocol
Patients who have a relationship of dependence or employer-employee relationship to the sponsor or the investigator
Primary purpose
Allocation
Interventional model
Masking
23 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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