Spots Global Cancer Trial Database for Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma

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Trial Identification

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

Official Title: Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma

Study ID: NCT01516593

Conditions

HIV

Burkitt's Lymphoma

Interventions

Induction Phase

Consolidation Phase (on day +50)

Intensification phase

BEAM conditioning

Consolidation radiotherapy

Study Description

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 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.

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 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%.