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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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%.
Sponsor: Andres J. M. Ferreri

Current Primary Outcome: evaluation of activity of the induction phase in terms of complete remission rate [ Time Frame: at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days ]

Objective lymphoma response achieved after the induction phase of the experimental treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Feasibility and tolerability of the investigational intensive chemotherapy in terms of grade ≥4 adverse events [ Time Frame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days ]
    Assessment of incidence of grade 4 AE during experimental treatment (induction, consolidation and intensification phases as well as conditioning and autologous stem cell transplantation (if indicated)
  • Feasibility and tolerability of the consolidation phase followed by BEAM conditioning and autologous stem cell transplantation in terms of prevalence of grade ≥4 adverse events [ Time Frame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days ]
  • Feasibility and tolerability of intensification phase in terms of prevalence of grade ≥4 adverse events [ Time Frame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days ]
    Participants who will not achieve a complete or partial response after induction and consolidation phases will be referred to intensification phase, which will be followed by BEAM + ASCT. These patients will be assess for tolerabbility and AE during these therapeutic phases.
  • Activity of the whole investigational program in terms of complete remission rate [ Time Frame: at the end of the whole program, an expected average of 100 days ]
    Participants will be assessed by conventional exams to define complete remission rate after the whole experiemntal program; that is after consolidation phase for patients who achieved complete remission after induction phase, after BEAM + ASCt for patients who achieved partial response after induction phase, and after intensification phase for patients who did not achieve an objective response after induction phase.


Original Secondary Outcome: Same as current

Information By: IRCCS San Raffaele

Dates:
Date Received: January 6, 2012
Date Started: November 2011
Date Completion: August 2015
Last Updated: January 24, 2012
Last Verified: January 2012