Status:
COMPLETED
Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma
Lead Sponsor:
Andres J. M. Ferreri
Conditions:
HIV
Burkitt's Lymphoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This is a multicenter,open-label trial to evaluate activity and safety of the investigational intensive in HIV+ patients with Burkitt's lymphoma. Experimental treatment consists of an induction phase...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Histologic diagnosis of Burkitt's lymphoma (WHO 2008)
- HIV sero-positivity
- Age ≥18 and ≤60 years
- ECOG-PS ≤3
Exclusion
- CNS parenchymal involvement
- Absolute neutrophil count \<1.000 cells/μL and platelets count \<75 × 109/L (Burkitt unrelated)
- Creatinine \>1,5N (Burkitt unrelated)
- SGOT and/or SGTP \>2,5N (Burkitt unrelated)
- Bilirubin \>2N (Burkitt unrelated)
- Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance
- Significant cardiac disease or acute myocardial infarction in the last 12 months
- Severe active infection (except for HBV and/or HCV co-infection)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01516593
Start Date
November 1 2011
End Date
August 1 2015
Last Update
August 4 2022
Active Locations (8)
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1
Oncologia Medica A - Centro di Riferimento Oncologico
Aviano (PN), Italy
2
Ematologia - A.O. Spedali Civili
Brescia, Italy
3
Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor
Milan, Italy
4
S.C. Oncologia Medica - Ospedale San Paolo
Milan, Italy