hematological B cell malignancies blood cell cancer
Conditions
Interventions
Suitable patients will be treated with a combined infusion of DLI (same dose as
the first DLI) with ex vivo cultured donor DCs that are a) stripped of PD-L
molecules by means of a siRNA transfection
only the first
administration will be combined with DLI. Patients will be examined for the
occurrence of side-effects, anti-tumor effect, influence on the immune system
and the development of speci
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with Multiple Myeloma (MM), Chronic Lymphocytic Leukemia (CLL), non hodgkin lymphoma (any grade), 2. Proven residual disease (including as determined by disease-specific or patient-specific PCR) minimally 6 months after allogeneic Stem Cell Transplantation (allo-SCT) and subsequent persistent or relapsed disease after a first therapeutic DLI 3. Recipient and donor have a mismatch in UTA2-1 mHag in the Graft versus Tumor (GvT) direction (recipient UTA2-1 positive, donor UTA2-1 negative). 4. Recipient and donor are positive for HLA-A*0201 5. Age 18-75 years 6. Absence of acute GvHD > grade 1 or extensive chronic GvHD 7. No treatment with immunosuppressive drugs such as prednisone, cyclosporine A and MMF at least 8 weeks prior to planned vaccination date. 8. WHO performance 0-2 9. Absence of severe cardiac hepatic, renal, or metabolic disease 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. WHO performance 3-4 2. Presence of severe cardiac hepatic, renal, metabolic disease 3. Rapidly progressive disease, despite reinduction therapy 4. Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters are -To evaluate the toxicity and feasibility of a DLI-combined minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination in B cell hematological malignancies - To evaluate the effect of a DLI-combined minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination on the immune status of the recipient in correlation with toxicity and response, including the investigation of the induction of UTA2-1 specific T cell responses after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Te secundary study parameter is to evaluate the efficacy of the DLI-combined minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination to induce a GvT for B cell hematological malignancies. | — |
Countries
Netherlands
Outcome results
None listed