Indolent B cell lymphoma C82 C83.0 C83.1
Conditions
Interventions
Group 1: The produced idiotype is mixed with an immunological adjuvant and is injected into the skin ("intrdermally"). In addition, patients receive for 5 days injections of GM-CSF subcutaneously
The
Sponsors
Abteilung Innere Medizin I
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Confirmed indolent B cell lymphoma Lymphoma biopsy feasible without general anesthesia Age > 18 years Informed consent
Exclusion criteria
Exclusion criteria: Monclonal paraprotein exceeding the normal concentrations for the respective Ig class Severe concomitant illness or infection Active CNS involvement Systemic antineoplastic therapy, other immunotherapy including steroids four weeks prior to vaccination pregnancy and lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction of humoral or cellular immunity against autologous idiotype and autologous lymphoma cells (antibodies, proliferation assay, ELISPOT, cytotoxicity test) at week 24 after the 1st vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective regression of lymphoma manifestations by computed tomography/MRI, laboratory tests, and bone marrow biopsy at week 8, 24, 36, and 52 after vaccination start || Duration of progression -free survival from start of vaccination by history and records | — |
Countries
Germany
Contacts
Public ContactHendrik Veelken
Abteilung Innere Medizin I Universitätsklinikum Freiburg
Outcome results
None listed