EUCTR2011-003487-75-IT
Active, not recruiting
Phase 1
Phase II trial on safety and activity of intensive short-term chemoimmunotherapy in HIV-positive patients with Burkitt's lymphoma.
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR0 sites19 target enrollmentDecember 23, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Burkitt's lymphoma in HIV-positive patients.
- Sponsor
- FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
- Enrollment
- 19
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histology of Burkitt's lymphoma according to the 2008 WHO classification. 2\. HIV sero\-positivity. 3\. Age \>/\= 18 and Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 19
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. CNS parenchymal involvement \[patients with meningeal dissemination (lymphomatous meningosis) are eligible]. 2\. Absolute neutrophil count \< 1\.000 cells/mcL and platelets count \< 75 × 1000000000/L (Burkitt unrelated). 3\. Creatinine \> 1,5 ULN (Burkitt unrelated). 4\. SGOT and/or SGTP \> 2,5 ULN (Burkitt unrelated). 5\. Bilirubin \> 2 ULN (Burkitt unrelated). 6\. Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance. 7\. Significant cardiac disease or acute myocardial infarction in the last 12 months. 8\. Severe active infection (HBV and/or HCV co\-infection does not constitute exclusion criteria in this trial). 9\. Pregnancy or lactation.
Outcomes
Primary Outcomes
Not specified
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