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

Primary Purpose

No Hodgkin B Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
RCOMP-14 + rituximab
Sponsored by
Asociacion Doctor Peset Para el Estudio de la Hematología
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for No Hodgkin B Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • hospital del Mar
  • Hospital Vall D'Hebrón
  • Hospital de Castellon
  • Hospital Severo Ochoa
  • Hospital Universitario Puerta de Hierro
  • Hospital de GetafeRecruiting
  • Hospital son Llatzer
  • Hospital Morales Messeguer
  • Hospital Santa Mª del Rosell
  • Hospital general universitario de Valencia
  • H. Arnau de Vilanova
  • Hospital Universitario Dr. Peset

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

unique

Arm Description

RCOMP-14 with Rituximab

Outcomes

Primary Outcome Measures

Evaluate treatment efficacy by measuring response to treatment

Secondary Outcome Measures

evaluate cardiotoxicity and tolerability
Evaluate progression free survival
Evaluate event free survival
Evaluate tumor free survival
Evaluate overall survival
Evaluate response duration
treatment adherence
time to progression
dose intensity and relative dose intensity

Full Information

First Posted
February 20, 2009
Last Updated
February 20, 2009
Sponsor
Asociacion Doctor Peset Para el Estudio de la Hematología
Collaborators
Cephalon, Pivotal S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT00849355
Brief Title
Ciclophosphamide, Vincristine, Myocet and Prednisone, With Rituximab in 1st-Line Treatment for Patients With No-Hodgkin B Lymphoma and Cardiovascular (CV) Risk
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Asociacion Doctor Peset Para el Estudio de la Hematología
Collaborators
Cephalon, Pivotal S.L.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
Phase II, multicenter, open , 1-arm study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
No Hodgkin B 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
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
unique
Arm Type
Experimental
Arm Description
RCOMP-14 with Rituximab
Intervention Type
Drug
Intervention Name(s)
RCOMP-14 + rituximab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate treatment efficacy by measuring response to treatment
Time Frame
at the end of study
Secondary Outcome Measure Information:
Title
evaluate cardiotoxicity and tolerability
Time Frame
At the end of study
Title
Evaluate progression free survival
Time Frame
At the end of study
Title
Evaluate event free survival
Time Frame
At the end of study
Title
Evaluate tumor free survival
Time Frame
At the end of study
Title
Evaluate overall survival
Time Frame
At the end of study
Title
Evaluate response duration
Time Frame
At the end of study
Title
treatment adherence
Time Frame
At the end of study
Title
time to progression
Time Frame
At the end of the study
Title
dose intensity and relative dose intensity
Time Frame
At the end of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histological diagnosis of Lymphoma no Hodgkin B CD20+ high degree of mailgnancy Patients no previously treated stage III o IV Informed consent At least one measurable injury Age >18 ECOG 0-2 Life expectancy >6 months Cardiovascular risk defined as:Mild-moderate systolic dysfunction,isquemic cardiopathy, diabetes mellitus, hypertension,left ventricular hypertrophy, cardiac arrhythmia, moderate pulmonar hypertension 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) Use of a contraceptive method during study + 3 months - Exclusion Criteria: stage I or II with IPI=0 Symptomatic tumoral affection of Nervous central system Lymphoma no hodgkin B indolent Lymphoma no hodgkin B mantle-cell Lymphoma no hodgkin T lymphoprolifertaive syndrome post-transplantation or immunosuppression associated cardiovacualr disease symptomatic Cronic infection or acute serious history of neoplasia in past 5 years not able to understand the study or poor protocol adherence Known Hypersensivity to any atudy drug pregnant/lactant women Previous participation in clinicla study in past 30 days Previous treatment with antraciclines or any drug used in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Secundino Ferrer
Phone
+34961622536
Email
ferrer_sec@gva.es
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Carbonell
Phone
+34961972000
Email
carbonell_fel@gav.es
Facility Information:
Facility Name
hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Vall D'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Castellon
City
Castellon
ZIP/Postal Code
12004
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Severo Ochoa
City
Madrid
ZIP/Postal Code
28211
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Sanchez
Phone
+34914818000
Email
psanchez.hsvo@salud.madrid.org
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
ZIP/Postal Code
28220
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Getafe
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose García
Phone
+34916839360
Email
garciavela.joseantonio@gmail.com
Facility Name
Hospital son Llatzer
City
Mallorca
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Morales Messeguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Sanchez
Phone
+34606388315
Email
josej.sanchezz3@carm.es
Facility Name
Hospital Santa Mª del Rosell
City
Murcia
ZIP/Postal Code
30203
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Martinez
Phone
+34968504800
Email
amartifran@ono.com
Facility Name
Hospital general universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
H. Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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