HIV Clinical Trial
— CARMENOfficial title:
Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma
NCT number | NCT01516593 |
Other study ID # | CARMEN |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 2011 |
Est. completion date | August 2015 |
Verified date | August 2022 |
Source | IRCCS San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | August 2015 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Italy | Oncologia Medica A - Centro di Riferimento Oncologico | Aviano (PN) | |
Italy | Ematologia - A.O. Spedali Civili | Brescia | |
Italy | Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor | Milano | |
Italy | S.C. Oncologia Medica - Ospedale San Paolo | Milano | |
Italy | S.C. Oncologia Medica 3 - IRCCS Istituto Nazionale Tumori (INT) | Milano | |
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 |
Lead Sponsor | Collaborator |
---|---|
Andres J. M. Ferreri |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | ||
Secondary | 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 | |
Secondary | 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 |
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