Trial on safety and activity of intensive short-term chemoimmunotherapy in patients with AIDS affected by Burkitt's lymphoma.

Phase 1

• Conditions: Burkitt's lymphoma in HIV-positive patients.; MedDRA version: 14.1Level: PTClassification code 10006595Term: Burkitt's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003487-75-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-23
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified