Ciclophosphamide, Vincristine, Myocet and Prednisone, With Rituximab in 1st-Line Treatment for Patients With No-Hodgkin B Lymphoma and Cardiovascular (CV) Risk

February 20, 2009 updated by: Asociacion Doctor Peset Para el Estudio de la Hematología

Phase II, Multicenter Trial to Evaluate the Efficacy and Safety of the Following Treatment Squeme:Ciclophosphamide, Vincristine, Lyposomal Doxorrubicine, Myocet and Prednisone,Combined With Rituximab in First Line Treatment for Patients With Aggresive No Hodgkin B Lymphoma and Cardiovascular Risk

The purpose of this study is to evaluate the efficacy (and safety) of the following treatment squeme:Ciclophosphamide, Vincristine, lyposomal Doxorrubicine (Myocet) and Prednisone,combined with Rituximab in first line treatment for patients with aggresive No Hodgkin B lymphoma and cardiovascular risk

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Phase II, multicenter, open , 1-arm study.

Study Type

Interventional

Enrollment (Anticipated)

44

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 Locations

  • Spain
      • Barcelona, Spain, 08003
        • Active, not recruiting
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Active, not recruiting
        • Hospital Vall D'Hebron
      • Castellon, Spain, 12004
        • Active, not recruiting
        • Hospital de Castellón
      • Madrid, Spain, 28211
      • Madrid, Spain, 28220
        • Active, not recruiting
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain
      • Mallorca, Spain, 07198
        • Active, not recruiting
        • Hospital Son Llatzer
      • Murcia, Spain, 30008
        • Not yet recruiting
        • Hospital Morales Messeguer
        • Contact:
      • Murcia, Spain, 30203
        • Not yet recruiting
        • Hospital Santa Mª del Rosell
        • Contact:
      • Valencia, Spain, 46014
        • Active, not recruiting
        • Hospital General Universitario de Valencia
      • Valencia, Spain, 46015
        • Active, not recruiting
        • H. Arnau de Vilanova
      • Valencia, Spain, 46017
        • Active, not recruiting
        • Hospital Universitario Dr. Peset

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with histological diagnosis of Lymphoma no Hodgkin B CD20+ high degree of mailgnancy
  2. Patients no previously treated
  3. stage III o IV
  4. Informed consent
  5. At least one measurable injury
  6. Age >18
  7. ECOG 0-2
  8. Life expectancy >6 months
  9. Cardiovascular risk defined as:Mild-moderate systolic dysfunction,isquemic cardiopathy, diabetes mellitus, hypertension,left ventricular hypertrophy, cardiac arrhythmia, moderate pulmonar hypertension
  10. adequate organic functionallity (creatinine<2mg/dl;bilirubin<2mg/dl; ALT-AST-FA<5 FSN; neutrphyls total count >1.5x 109/l and platellet count >100x1097l)
  11. Use of a contraceptive method during study + 3 months -

Exclusion Criteria:

  1. stage I or II with IPI=0
  2. Symptomatic tumoral affection of Nervous central system
  3. Lymphoma no hodgkin B indolent
  4. Lymphoma no hodgkin B mantle-cell
  5. Lymphoma no hodgkin T
  6. lymphoprolifertaive syndrome post-transplantation or immunosuppression associated
  7. cardiovacualr disease symptomatic
  8. Cronic infection or acute serious
  9. history of neoplasia in past 5 years
  10. not able to understand the study or poor protocol adherence
  11. Known Hypersensivity to any atudy drug
  12. pregnant/lactant women
  13. Previous participation in clinicla study in past 30 days
  14. Previous treatment with antraciclines or any drug used in this study

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: unique
RCOMP-14 with Rituximab
Drug: RCOMP-14 + rituximab

Pretreatment: vincristine 1mg at day -6 and Methylprednisolone 100 mg from -6 to day 0.

Treatment: rituximab 375m/m2 + ciclophosphamide 750 mg/m2 + Vincristine 1.4 mg/m2 + Doxorrubicine 50 mg/m2 at day 1 and every 14d. Prednisone 100 mg/d from day 1 to 5 and every 14 d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate treatment efficacy by measuring response to treatment
Time Frame: at the end of study
at the end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
evaluate cardiotoxicity and tolerability
Time Frame: At the end of study
At the end of study
Evaluate progression free survival
Time Frame: At the end of study
At the end of study
Evaluate event free survival
Time Frame: At the end of study
At the end of study
Evaluate tumor free survival
Time Frame: At the end of study
At the end of study
Evaluate overall survival
Time Frame: At the end of study
At the end of study
Evaluate response duration
Time Frame: At the end of study
At the end of study
treatment adherence
Time Frame: At the end of study
At the end of study
time to progression
Time Frame: At the end of the study
At the end of the study
dose intensity and relative dose intensity
Time Frame: At the end of the study
At the end of the study

Collaborators and Investigators

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

Sponsor

Asociacion Doctor Peset Para el Estudio de la Hematología

Collaborators

Cephalon
Pivotal S.L.

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

August 1, 2008

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (Estimate)

February 23, 2009

Study Record Updates

Last Update Posted (Estimate)

February 23, 2009

Last Update Submitted That Met QC Criteria

February 20, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADOPEH-LINFMYO-2007

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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