Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma (CARMEN)
This study is currently recruiting participants.
Verified January 2012 by IRCCS San Raffaele
Sponsor:
Andres J. M. Ferreri
Information provided by (Responsible Party):
Andres J. M. Ferreri, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01516593
First received: January 6, 2012
Last updated: January 24, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Burkitt's Lymphoma |
Drug: Induction Phase Drug: Consolidation Phase (on day +50) Drug: Intensification phase Drug: BEAM conditioning Radiation: Consolidation radiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Cytarabine
U.S. FDA Resources
Further study details as provided by IRCCS San Raffaele:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]Objective lymphoma response achieved after the induction phase of the experimental treatment.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]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)
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]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 [ Time Frame: at the end of the whole program, an expected average of 100 days ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 19 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: intensive short term immuno-chemotherapy
Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
|
Drug: Induction Phase
At the end of this induction phase, subsequent treatment will be performed according to the objective response:
Other Name: Short-term intensive sequential chemoimmunotherapy
Drug: Consolidation Phase (on day +50)
Other Name: high-dose cytarabine; consolidation phase
Drug: Intensification phase
Other Name: unresponsive patients, refractory disease
Drug: BEAM conditioning
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 Name: Conditioning regimen, autologous transplantation
Radiation: Consolidation radiotherapy
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 Name: bulky irradiation; residual lesion
|
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516593
Contacts
| Contact: Andrés JM Ferreri, MD | +39022643 ext 7649 | ferreri.andres@hsr.it |
| Contact: Marta Bruno Ventre, MD | +39022643 ext 7612 | brunoventre.marta@hsr.it |
Locations
| Italy | |
| Oncologia Medica A - Centro di Riferimento Oncologico | Not yet recruiting |
| Aviano (PN), Italy | |
| Contact: Michele Spina, MD +300434659 ext 284 mspina@cro.it | |
| Principal Investigator: Michele Spina, MD | |
| Ematologia - A.O. Spedali Civili | Not yet recruiting |
| Brescia, Italy | |
| Contact: Alessandro Re, MD +39030399 ext 5438 sandrore@aruba.it | |
| Principal Investigator: Alessandro Re, MD | |
| Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor | Recruiting |
| Milano, Italy | |
| Contact: Andrés JM Ferreri, MD +39022643 ext 7649 ferreri.andres@hsr.it | |
| Contact: Marta Bruno Ventre, MD brunoventre.marta@hsr.it | |
| Principal Investigator: Andrés JM Ferreri, MD | |
| S.C. Oncologia Medica 3 - IRCCS Istituto Nazionale Tumori (INT) | Not yet recruiting |
| Milano, Italy | |
| Contact: Massimo Di Nicola, MD +39022390 ext 2360 massimo.dinicola@istitutotumori.mi.it | |
| Principal Investigator: Massimo Di Nicola, MD | |
| S.C. Oncologia Medica - Ospedale San Paolo | Not yet recruiting |
| Milano, Italy | |
| Contact: Niccolò Frungillo, MD niccolo.frungillo@ao.sanpaolo.it | |
| Principal Investigator: Niccolò Frungillo, MD | |
| U.O.C. Immunodeficienze virali - I.N.M.I. L. Spallanzani | Not yet recruiting |
| Roma, Italy | |
| Contact: Andrea Antinori, MD +390655170 ext 348 andrea.antinori@inmi.it | |
| Principal Investigator: Andrea Antinori, MD | |
| S.C. Oncoematologia - A.O. Santa Maria | Not yet recruiting |
| Terni, Italy | |
| Contact: Anna Marina Liberati, MD +390744205 ext 971 marinal@unipg.it | |
| Principal Investigator: Anna Marina Liberati, MD | |
| U.O. Ematologia 2 - Ospedale San Giovanni Battista | Not yet recruiting |
| Torino, Italy | |
| Contact: Dino Allione, MD +39011633 ext 6685 ballione@molinette.piemonte.it | |
| Principal Investigator: Dino Allione, MD | |
Sponsors and Collaborators
Andres J. M. Ferreri
Investigators
| Study Chair: | Andrés JM Ferreri, MD | San Raffaele Scientific Institute, Milano, Italy |
More Information
No publications provided
| Responsible Party: | Andres J. M. Ferreri, MD, IRCCS San Raffaele |
| ClinicalTrials.gov Identifier: | NCT01516593 History of Changes |
| Other Study ID Numbers: | CARMEN |
| Study First Received: | January 6, 2012 |
| Last Updated: | January 24, 2012 |
| Health Authority: | Italy: Ethics Committee Italy: The Italian Medicines Agency |
Keywords provided by IRCCS San Raffaele:
|
HIV Burkitt's lymphoma intensive |
short term immuno-chemotherapy HIV-positive patients with Burkitt's lymphoma |
Additional relevant MeSH terms:
|
Burkitt Lymphoma HIV Seropositivity Lymphoma Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoma, B-Cell Neoplasms, Experimental Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Cytarabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013