Clinical trials of B-CLL patients treated with Apo-DC +/- GM-CSF in progressclinical study dataset
We have further data available on a clinical trial on vaccination of B-CLL patients with autologous, apoptotic, leukemic cells (Apo-DC). Cohort 1 with the vaccine alone and cohort 2 (5 patients) combining the vaccine together with GM-CSF as an adjuvant has finished accrual and all patients in these two cohorts have been monitored for 52 weeks. The clinical and immune monitoring data is being currently analyzed.
The third cohort consisting of the vaccine and GM-CSF administered after a single dose of cyclophosphamide (300 mg/ sq. meter) is currently being accrued. Four of the five patients in this cohort have already received their vaccine and the final patient will be accrued in January. Further cohorts that combine Apo-DC vaccination with leukemia debulking therapy is currently being considered for submission to the Swedish Medical Products Agency.
Immunological monitoring in these patients involving leukemia-specific lymphocyte proliferation and ELISPOT assays, phenotyping of immune cells, assaying cytokine using luminex technology and expression of CD107 as a surrogate marker for cytotoxicity, before and after vaccination is ongoing.
Further cohorts that combine Apo-DC vaccination with leukemia debulking therapy is currently being considered for submission to the Swedish Medical Products Agency.
- organism type
- Homo sapiens
- experimental design type
- in vivo design experiment