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

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.

Conditions

• HIV
• Burkitt's Lymphoma

Interventions

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

Sponsors & Collaborators

• Andres J. M. Ferreri

  lead OTHER

Principal Investigators

• Andrés JM Ferreri, MD · San Raffaele Scientific Institute, Milano, Italy

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2013-04-30

Completion

2015-08-31

Countries

• Italy

Study Locations