NCT01516593

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Andres J. M. Ferreri · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• HIV
• Burkitt's Lymphoma

Interventions

Type	Name	Description
DRUG	Induction Phase	* 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: 1. pts in CR: consolidation phase followed by bulky site irradiation 2. pts in PR: consolidation phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation 3. pts with SD after induction or PD during or after induction: intensification phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation
DRUG	Consolidation Phase (on day +50)	* dd 1-2: cytarabine twice a day * dd 3 and 11: rituximab * dd 11-13: leukapheresis for PBPC collection.
DRUG	Intensification phase	1. One or two courses of R-IVAC or R-ICE chemoimmunotherapy regimen, every three weeks as debulking. 2. CTX (dd 1) associated with rituximab on dd 3 and 10, followed by PBPC collection (dd 11-13); 3. 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).
DRUG	BEAM conditioning	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
RADIATION	Consolidation radiotherapy	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

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-04-01
• Completion: 2015-08-01
• First posted: 2012-01-25
• Last updated: 2022-08-04

Locations

8 sites across 1 country: Italy