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

October 12, 2011 updated by: Fondazione Italiana Linfomi ONLUS

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Alessandria, Italy
        • Recruiting
        • Ospedale SS Antonio Biagio e Cesare Arrigo
      • Bari, Italy
        • Not yet recruiting
        • Universita Di Bari
        • Principal Investigator:
          • Giorgina Specchia, MD
      • Biella, Italy
        • Not yet recruiting
        • Ospedale Degli Infermi
        • Principal Investigator:
          • Anna Tonso, MD
      • Brescia, Italy
        • Not yet recruiting
        • Spedali Civili
        • Principal Investigator:
          • Giuseppe Rossi, MD
      • Civitanova Marche, Italy
        • Not yet recruiting
        • Ospedale Civitanova Marche
        • Principal Investigator:
          • Riccardo Centurioni, MD
      • Cosenza, Italy
        • Not yet recruiting
        • AO Annunziata
      • Cosenza, Italy
        • Not yet recruiting
        • Ospedale San Carlo
      • Lecce, Italy
        • Not yet recruiting
        • Ospedale Vito Fazzi
      • Meldola (FC), Italy
        • Not yet recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
      • Messina, Italy
        • Not yet recruiting
        • A O Papardo
      • Milano, Italy
        • Not yet recruiting
        • Ospedale San Raffaele
      • Milano, Italy
        • Not yet recruiting
        • Ospedale Niguarda Cà Granda
        • Principal Investigator:
          • Livio Gargantini, MD
      • Modena, Italy
        • Recruiting
        • Centro Oncologico Modenese
      • Palermo, Italy
        • Not yet recruiting
        • Ospedale La Maddalena
      • Palermo, Italy
        • Not yet recruiting
        • AO Universitaria Paolo Giaccone
      • Parma, Italy
        • Not yet recruiting
        • A O Universitaria di Parma
        • Principal Investigator:
          • Vittorio Rizzoli, MD
      • Perugia, Italy
        • Not yet recruiting
        • Ospedale Santa Maria della Misericordia
      • Ravenna, Italy
        • Not yet recruiting
        • Ausl Ravenna
      • Reggio Calabria, Italy
        • Not yet recruiting
        • Ospedale Bianchi Melacrino Morelli
      • Reggio Emilia, Italy
        • Not yet recruiting
        • AO Santa Maria Nuova
      • Rimini, Italy
        • Not yet recruiting
        • Ausl Rimini
        • Principal Investigator:
          • Pier Paolo Fattori, MD
      • Roma, Italy
        • Not yet recruiting
        • Istituto Regina Elena
        • Principal Investigator:
          • Antonio Spadea, MD
      • Roma, Italy
        • Not yet recruiting
        • Ospedale Sant'Eugenio
      • Roma, Italy
        • Not yet recruiting
        • Università La Sapienza
      • Rozzano (MI), Italy
        • Not yet recruiting
        • Clinica Humanitas
        • Principal Investigator:
          • Balzarotti Monica, MD
      • San giovanni Rotondo, Italy
        • Not yet recruiting
        • Casa Sollievo della Sofferenza
      • Sassari, Italy
        • Not yet recruiting
        • Università di Sassari
      • Siena, Italy
        • Not yet recruiting
        • Azienda Ospedaliera senese
      • Torino, Italy
        • Not yet recruiting
        • Ospedale San Giovanni Battista Molinette
      • Trieste, Italy
        • Not yet recruiting
        • Ospedale Riuniti
        • Principal Investigator:
          • Gabriele Pozzato, MD
      • Udine, Italy
        • Not yet recruiting
        • Santa Maria della Misericordia
      • Varese, Italy
        • Not yet recruiting
        • Ospedale di Circolo e Fondazione Macchi
        • Principal Investigator:
          • Gabriella Pinotti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
R-COMP
Drug: Rituximab
375 mg/m2 day 1
Drug: Cyclophosphamide
750 mg/m2 day 2
Drug: Vincristine
1,4 mg/m2 (max 2 mg) day 2
Drug: Prednisone
40 mg/m2 day 2-6
Drug: Doxorubicin
50 mg/m2 day 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of R-COMP in cardiopathic patients
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 2 years
2 years
Overall Survival
Time Frame: 3 years
3 years
Response rates
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Investigators

  • Study Director: Michele Spina, MD, Centro di Riferimento Oncologico di Aviano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (ESTIMATE)

November 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIL-HEART01
  • 2009-012143-42

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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