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Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma

Primary Purpose

Diffuse Large B-Cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Rituximab
Cyclophosphamide
Vincristine
Prednisone
Doxorubicin
Sponsored by
Fondazione Italiana Linfomi - ETS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring Diffuse Large B-Cell Lymphoma

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL;
  • Age >= 18 years;
  • Presence of at least 1 factor that defines the cardiopathy;
  • Life expectancy > 3 months;
  • In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy;
  • Written informed consent.

Exclusion Criteria:

  • Histology different from NHL diffuse large cell CD20 + or follicular IIIb
  • Age < 18 years
  • Inability to sign informed consent;
  • HIV positivity;
  • Patients HBsAg positive;
  • AST/ALT > 2 times the standard;
  • Bilirubin > 2 times the standard;
  • Creatinine > 2.5 mg / dl;
  • Location of CNS disease;
  • Pregnancy ongoing;
  • Damage to that organ or medical problems that could interfere with the therapy;
  • Current uncontrolled infection;
  • Senile dementia

Sites / Locations

  • Ospedale SS Antonio Biagio e Cesare ArrigoRecruiting
  • Università di Bari
  • Ospedale degli Infermi
  • Spedali Civili
  • Ospedale Civitanova Marche
  • AO Annunziata
  • Ospedale San Carlo
  • Ospedale Vito Fazzi
  • Istituto Scientifico Romagnolo per lo studio e la cura dei tumori (IRST)
  • A O Papardo
  • Ospedale Niguarda Cà Granda
  • Ospedale San Raffaele
  • Centro oncologico modeneseRecruiting
  • AO Universitaria Paolo Giaccone
  • Ospedale La Maddalena
  • A O Universitaria di Parma
  • Ospedale Santa Maria della Misericordia
  • Ausl Ravenna
  • Ospedale Bianchi Melacrino Morelli
  • AO Santa Maria Nuova
  • Ausl Rimini
  • Istituto Regina Elena
  • Ospedale Sant'Eugenio
  • Università La Sapienza
  • Clinica Humanitas
  • Casa sollievo della sofferenza
  • Università di Sassari
  • Azienda Ospedaliera senese
  • Ospedale San Giovanni Battista Molinette
  • Ospedale Riuniti
  • Santa Maria della Misericordia
  • Ospedale di circolo e Fondazione Macchi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

R-COMP

Outcomes

Primary Outcome Measures

Feasibility of R-COMP in cardiopathic patients

Secondary Outcome Measures

Response rates
Progression free survival
Overall Survival

Full Information

First Posted
November 6, 2009
Last Updated
October 12, 2011
Sponsor
Fondazione Italiana Linfomi - ETS
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1. Study Identification

Unique Protocol Identification Number
NCT01009970
Brief Title
Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma
Official Title
Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Italiana Linfomi - ETS

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma
Keywords
Diffuse Large B-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
R-COMP
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m2 day 1
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
750 mg/m2 day 2
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
1,4 mg/m2 (max 2 mg) day 2
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
40 mg/m2 day 2-6
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
50 mg/m2 day 2
Primary Outcome Measure Information:
Title
Feasibility of R-COMP in cardiopathic patients
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Response rates
Time Frame
1 year
Title
Progression free survival
Time Frame
2 years
Title
Overall Survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL; Age >= 18 years; Presence of at least 1 factor that defines the cardiopathy; Life expectancy > 3 months; In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy; Written informed consent. Exclusion Criteria: Histology different from NHL diffuse large cell CD20 + or follicular IIIb Age < 18 years Inability to sign informed consent; HIV positivity; Patients HBsAg positive; AST/ALT > 2 times the standard; Bilirubin > 2 times the standard; Creatinine > 2.5 mg / dl; Location of CNS disease; Pregnancy ongoing; Damage to that organ or medical problems that could interfere with the therapy; Current uncontrolled infection; Senile dementia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Denaro
Phone
0039-0131-206129
Email
ddenaro@ospedale.al.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Spina, MD
Organizational Affiliation
Centro di riferimento Oncologico di Aviano
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale SS Antonio Biagio e Cesare Arrigo
City
Alessandria
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Levis, MD
Facility Name
Università di Bari
City
Bari
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgina Specchia, MD
Facility Name
Ospedale degli Infermi
City
Biella
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Tonso, MD
Facility Name
Spedali Civili
City
Brescia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Rossi, MD
Facility Name
Ospedale Civitanova Marche
City
Civitanova Marche
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riccardo Centurioni, MD
Facility Name
AO Annunziata
City
Cosenza
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale San Carlo
City
Cosenza
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Attilio Olivieri, MD
Facility Name
Ospedale Vito Fazzi
City
Lecce
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Di Renzo, MD
Facility Name
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori (IRST)
City
Meldola (FC)
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dino Amadori, MD
Facility Name
A O Papardo
City
Messina
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maura Brugiatelli, MD
Facility Name
Ospedale Niguarda Cà Granda
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Livio Gargantini, MD
Facility Name
Ospedale San Raffaele
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andres Ferreri, MD
Facility Name
Centro oncologico modenese
City
Modena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Federico, MD
Facility Name
AO Universitaria Paolo Giaccone
City
Palermo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatrice Mancuso, MD
Facility Name
Ospedale La Maddalena
City
Palermo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Musso, MD
Facility Name
A O Universitaria di Parma
City
Parma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vittorio Rizzoli, MD
Facility Name
Ospedale Santa Maria della Misericordia
City
Perugia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo Flenghi, MD
Facility Name
Ausl Ravenna
City
Ravenna
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Zaccaria, MD
Facility Name
Ospedale Bianchi Melacrino Morelli
City
Reggio Calabria
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caterina Stelitano, MD
Facility Name
AO Santa Maria Nuova
City
Reggio Emilia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Merli, MD
Facility Name
Ausl Rimini
City
Rimini
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pier Paolo Fattori, MD
Facility Name
Istituto Regina Elena
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Spadea, MD
Facility Name
Ospedale Sant'Eugenio
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabetta Abruzzese, MD
Facility Name
Università La Sapienza
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Martelli, MD
Facility Name
Clinica Humanitas
City
Rozzano (MI)
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Balzarotti Monica, MD
Facility Name
Casa sollievo della sofferenza
City
San giovanni Rotondo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Cascavilla, MD
Facility Name
Università di Sassari
City
Sassari
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Longinotti, MD
Facility Name
Azienda Ospedaliera senese
City
Siena
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Fabbri, MD
Facility Name
Ospedale San Giovanni Battista Molinette
City
Torino
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umberto Vitolo, MD
Facility Name
Ospedale Riuniti
City
Trieste
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Pozzato, MD
Facility Name
Santa Maria della Misericordia
City
Udine
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Zaja, MD
Facility Name
Ospedale di circolo e Fondazione Macchi
City
Varese
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Pinotti, MD

12. IPD Sharing Statement

Learn more about this trial

Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma

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