Vaccination with recombinant lymphoma idiotype in indolent lymphoma in advanced stages
Phase 2
- Conditions
- Indolent B cell lymphomaC82C83.0C83.1Follicular lymphomaSmall cell B-cell lymphomaMantle cell lymphoma
- Registration Number
- DRKS00000227
- Lead Sponsor
- Abteilung Innere Medizin IUniversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Confirmed indolent B cell lymphoma
Lymphoma biopsy feasible without general anesthesia
Age > 18 years
Informed consent
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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