Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma
Condition: HIV; Burkitt's Lymphoma
MeSH terms: Burkitt Lymphoma; HIV Seropositivity; Lymphoma
Study type: Interventional
Phase: Phase 2

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%.
    

Intervention name(s): Induction Phase; Consolidation Phase (on day +50); Intensification phase; BEAM conditioning; Consolidation radiotherapy
Intervention type(s): Drug; Drug; Drug; Drug; Radiation
Intervention description(s): dd -2 to 1: Methylprednisolone
dd 0-1, Cyclophosphamide, associated on day 0 with Vincristine
dd 2, Rituximab
dd 7, Methotrexate
dd 14, Rituximab
dd 15, Etoposide
dd 21, Methotrexate
dd 29, Rituximab and Doxorubicin
dd 36, Rituximab and VCR
At the end of this induction phase, subsequent treatment will be performed according to the objective response:
pts in CR: consolidation phase followed by bulky site irradiation
pts in PR: consolidation phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation
pts with SD after induction or PD during or after induction: intensification phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation; dd 1-2: cytarabine twice a day
dd 3 and 11: rituximab
dd 11-13: leukapheresis for PBPC collection.; One or two courses of R-IVAC or R-ICE chemoimmunotherapy regimen, every three weeks as debulking.
CTX (dd 1) associated with rituximab on dd 3 and 10, followed by PBPC collection (dd 11-13);
AraC every 12 hours for four days (dd -5 to -2) supported by reinfusion of CD34+ cells (dd 0), rituximab infusion (dd -1 and +11) and second in-vivo purged PBPC collection (if needed).; BCNU on dd 1; VP-16 every 12 hours on dd 2-5 and araC every 12 hours on dd 2-5; melphalan on dd 6, followed by the reinfusion of CD34+ cells; At the end of the whole program, patients will be evaluated for involved-field irradiation with 6-10 MeV photons and a dose of 36 Gy (2 Gy/d, five fractions a week). Three subgroups of patients will be considered for radiotherapy
Other intervention name(s): Short-term intensive sequential chemoimmunotherapy; high-dose cytarabine; consolidation phase; unresponsive patients, refractory disease; Conditioning regimen, autologous transplantation; bulky irradiation; residual lesion
Intervention MeSH terms: Cytarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Burkitt's lymphoma; intensive; short term; immuno-chemotherapy; HIV-positive patients with Burkitt's lymphoma