NCT00849355

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 23, 2009

Status Verified

February 1, 2009

Enrollment Period

1.3 years

First QC Date

February 20, 2009

Last Update Submit

February 20, 2009

Conditions

No Hodgkin B Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Evaluate treatment efficacy by measuring response to treatment

    at the end of study

Secondary Outcomes (9)

  • evaluate cardiotoxicity and tolerability

    At the end of study

  • Evaluate progression free survival

    At the end of study

  • Evaluate event free survival

    At the end of study

  • Evaluate tumor free survival

    At the end of study

  • Evaluate overall survival

    At the end of study

  • +4 more secondary outcomes

Study Arms (1)

unique

EXPERIMENTAL

RCOMP-14 with Rituximab

Drug: RCOMP-14 + rituximab

Interventions

RCOMP-14 + rituximabDRUG

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.

unique

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

hospital del Mar

Barcelona, 08003, Spain

ACTIVE NOT RECRUITING

Hospital Vall D'Hebrón

Barcelona, 08035, Spain

ACTIVE NOT RECRUITING

Hospital de Castellon

Castellon, 12004, Spain

ACTIVE NOT RECRUITING

Hospital Severo Ochoa

Madrid, 28211, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, 28220, Spain

ACTIVE NOT RECRUITING

Hospital de Getafe

Madrid, Spain

RECRUITING

Hospital son Llatzer

Mallorca, 07198, Spain

ACTIVE NOT RECRUITING

Hospital Morales Messeguer

Murcia, 30008, Spain

NOT YET RECRUITING

Hospital Santa Mª del Rosell

Murcia, 30203, Spain

NOT YET RECRUITING

Hospital general universitario de Valencia

Valencia, 46014, Spain

ACTIVE NOT RECRUITING

H. Arnau de Vilanova

Valencia, 46015, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Secundino Ferrer

CONTACT

+34961622536ferrer_sec@gva.es

Felix Carbonell

CONTACT

+34961972000carbonell_fel@gav.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 23, 2009

Study Start

August 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2010

Last Updated

February 23, 2009

Record last verified: 2009-02

Locations

ES(12)