Overview

Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma

Status:
Unknown status
Trial end date:
2015-08-01
Target enrollment:
0
Participant gender:
All
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 followed by a consolidation or intensified phase according to tumor response. Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL was thought to limit the ability to administer intensive chemotherapeutic regimens due to infection rate. However, the advent of highly active antiretroviral therapy (HAART) and evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard chemotherapeutic regimens with improved outcomes have led investigators to treat HIV-positive patients with the same intensive chemotherapy regimens used to treat immuno-competent patients. Data suggest that these current approaches, along with supportive care, may result in improved patient outcomes, similar to those in the immuno-competent patient population.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Andres J. M. Ferreri
Treatments:
Cytarabine
Criteria
Inclusion Criteria:

- Histologic diagnosis of Burkitt's lymphoma (WHO 2008)

- HIV sero-positivity

- Age ≥18 and ≤60 years

- ECOG-PS ≤3

Exclusion Criteria:

- 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)