Clinical trial NCT01516593: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Burkitt's Lymphoma
Keywords: HIV
Burkitt's lymphoma
intensive
short term
immuno-chemotherapy
HIV-positive patients with Burkitt's lymphoma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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%.

Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of Burkitt's lymphoma (WHO 2008)
* HIV sero-positivity
* Age ≥18 and ≤60 years
* ECOG-PS ≤3

Exclusion Criteria:

* CNS parenchymal involvement
* Absolute neutrophil count \<1.000 cells/μL and platelets count \<75 × 109/L (Burkitt unrelated)
* Creatinine \>1,5N (Burkitt unrelated)
* SGOT and/or SGTP \>2,5N (Burkitt unrelated)
* Bilirubin \>2N (Burkitt unrelated)
* Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance
* Significant cardiac disease or acute myocardial infarction in the last 12 months
* Severe active infection (except for HBV and/or HCV co-infection)

Primary outcomes:
measure: evaluation of activity of the induction phase in terms of complete remission rate
timeFrame: at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days
Secondary outcomes:
measure: Feasibility and tolerability of the investigational intensive chemotherapy in terms of grade ≥4 adverse events
timeFrame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days
measure: 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
timeFrame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days
measure: Feasibility and tolerability of intensification phase in terms of prevalence of grade ≥4 adverse events
timeFrame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days
measure: Activity of the whole investigational program in terms of complete remission rate
timeFrame: at the end of the whole program, an expected average of 100 days
Other outcomes:
Locations:
city: Aviano (PN)
country: Italy
facility: Oncologia Medica A - Centro di Riferimento Oncologico
city: Brescia
country: Italy
facility: Ematologia - A.O. Spedali Civili
city: Milano
country: Italy
facility: Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor
city: Milano
country: Italy
facility: S.C. Oncologia Medica - Ospedale San Paolo
city: Milano
country: Italy
facility: S.C. Oncologia Medica 3 - IRCCS Istituto Nazionale Tumori (INT)
city: Roma
country: Italy
facility: U.O.C. Immunodeficienze virali - I.N.M.I. L. Spallanzani
city: Terni
country: Italy
facility: S.C. Oncoematologia - A.O. Santa Maria
city: Torino
country: Italy
facility: U.O. Ematologia 2 - Ospedale San Giovanni Battista
Study officials:
affiliation: San Raffaele Scientific Institute, Milano, Italy
name: Andrés JM Ferreri, MD
role: STUDY_CHAIR
References: