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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 CA 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Feasibility of R-COMP in cardiopathic patients
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Italiana Linfomi ONLUS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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