Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma
The activity of feasibility of the proposed program will be assessed in HIV+ patients with
Burkitt lymphoma with the aim to improve tolerability, minimize source consuming and
supporting treatment and redu ce late sequels. Available combinations in this setting are
really source demanding and toxic combinations showing high rates of septic complication and
a treatment-related mortality of near 20%.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
evaluation of activity of the induction phase in terms of complete remission rate
Objective lymphoma response achieved after the induction phase of the experimental treatment.
at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days
Yes
Andrés JM Ferreri, MD
Study Chair
San Raffaele Scientific Institute, Milano, Italy
Italy: Ethics Committee
CARMEN
NCT01516593
November 2011
August 2015
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