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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive short term immuno-chemotherapy | Experimental | Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction Phase | Drug |
At the end of this induction phase, subsequent treatment will be performed according to the objective response:
|
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of activity of the induction phase in terms of complete remission rate | Objective lymphoma response achieved after the induction phase of the experimental treatment. | at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and tolerability of the investigational intensive chemotherapy in terms of grade ≥4 adverse events | 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) | participants will be followed for the duration of the whole experimental program, an expected average of 100 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrés JM Ferreri, MD | San Raffaele Scientific Institute, Milano, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncologia Medica A - Centro di Riferimento Oncologico | Aviano (PN) | Italy | ||||
| Ematologia - A.O. Spedali Civili |
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|
|
| Consolidation Phase (on day +50) | Drug |
|
|
|
| Intensification phase | Drug |
|
|
|
| BEAM conditioning | Drug | 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 |
|
|
| Consolidation radiotherapy | Radiation | 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 |
|
|
| 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 intensification phase in terms of prevalence of grade ≥4 adverse events | 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. | participants will be followed for the duration of the whole experimental program, an expected average of 100 days |
| Activity of the whole investigational program in terms of complete remission rate | 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. | at the end of the whole program, an expected average of 100 days |
| Brescia |
| Italy |
| Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor | Milan | Italy |
| S.C. Oncologia Medica - Ospedale San Paolo | Milan | Italy |
| S.C. Oncologia Medica 3 - IRCCS Istituto Nazionale Tumori (INT) | Milan | Italy |
| U.O.C. Immunodeficienze virali - I.N.M.I. L. Spallanzani | Roma | Italy |
| S.C. Oncoematologia - A.O. Santa Maria | Terni | Italy |
| U.O. Ematologia 2 - Ospedale San Giovanni Battista | Torino | Italy |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D019172 | Transplantation Conditioning |
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D007165 | Immunosuppression Therapy |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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