- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01516593
Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma (CARMEN)
Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Aviano (PN), Italy
- Oncologia Medica A - Centro di Riferimento Oncologico
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Brescia, Italy
- Ematologia - A.O. Spedali Civili
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Milano, Italy
- Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor
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Milano, Italy
- S.C. Oncologia Medica - Ospedale San Paolo
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Milano, Italy
- S.C. Oncologia Medica 3 - IRCCS Istituto Nazionale Tumori (INT)
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Roma, Italy
- U.O.C. Immunodeficienze virali - I.N.M.I. L. Spallanzani
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Terni, Italy
- S.C. Oncoematologia - A.O. Santa Maria
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Torino, Italy
- U.O. Ematologia 2 - Ospedale San Giovanni Battista
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intensive short term immuno-chemotherapy
Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
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At the end of this induction phase, subsequent treatment will be performed according to the objective response:
Other Names:
Other Names:
Other Names:
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
Other Names:
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluation of activity of the induction phase in terms of complete remission rate
Time Frame: at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days
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Objective lymphoma response achieved after the induction phase of the experimental treatment.
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at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and tolerability of the investigational intensive chemotherapy in terms of grade ≥4 adverse events
Time Frame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days
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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)
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participants will be followed for the duration of the whole experimental program, an expected average of 100 days
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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
Time Frame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days
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participants will be followed for the duration of the whole experimental program, an expected average of 100 days
|
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Feasibility and tolerability of intensification phase in terms of prevalence of grade ≥4 adverse events
Time Frame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days
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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.
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participants will be followed for the duration of the whole experimental program, an expected average of 100 days
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Activity of the whole investigational program in terms of complete remission rate
Time Frame: at the end of the whole program, an expected average of 100 days
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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.
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at the end of the whole program, an expected average of 100 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Andrés JM Ferreri, MD, San Raffaele Scientific Institute, Milano, Italy
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- DNA Virus Infections
- Tumor Virus Infections
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- HIV Infections
- Lymphoma, B-Cell
- Lymphoma
- Burkitt Lymphoma
- HIV Seropositivity
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cytarabine
Other Study ID Numbers
- CARMEN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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