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

Phase 2

Completed

• Conditions: HIV; Burkitt's Lymphoma
• Interventions: Drug: Induction Phase; Drug: Consolidation Phase (on day +50); Drug: Intensification phase; Drug: BEAM conditioning; Radiation: Consolidation radiotherapy

• Registration Number: NCT01516593
• Lead Sponsor: Andres J. M. Ferreri

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%.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Primary Completion: 2013-04
• Study Completion: 2015-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intensive short term immuno-chemotherapy	Induction Phase	Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
intensive short term immuno-chemotherapy	Consolidation Phase (on day +50)	Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
intensive short term immuno-chemotherapy	Intensification phase	Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
intensive short term immuno-chemotherapy	BEAM conditioning	Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
intensive short term immuno-chemotherapy	Consolidation radiotherapy	Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.

Primary Outcome Measures

Name	Time	Method
evaluation of activity of the induction phase in terms of complete remission rate	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility and tolerability of intensification phase in terms of prevalence of grade ≥4 adverse events	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	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.
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	participants will be followed for the duration of the whole experimental program, an expected average of 100 days
Feasibility and tolerability of the investigational intensive chemotherapy in terms of grade ≥4 adverse events	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)

Trial Locations

Locations (8)

Ematologia - A.O. Spedali Civili; 🇮🇹 Brescia, Italy

Oncologia Medica A - Centro di Riferimento Oncologico; 🇮🇹 Aviano (PN), Italy

Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor; 🇮🇹 Milano, Italy

U.O. Ematologia 2 - Ospedale San Giovanni Battista; 🇮🇹 Torino, Italy

S.C. Oncologia Medica 3 - IRCCS Istituto Nazionale Tumori (INT); 🇮🇹 Milano, Italy

S.C. Oncoematologia - A.O. Santa Maria; 🇮🇹 Terni, Italy

U.O.C. Immunodeficienze virali - I.N.M.I. L. Spallanzani; 🇮🇹 Roma, Italy

S.C. Oncologia Medica - Ospedale San Paolo; 🇮🇹 Milano, Italy