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

Sponsors and Collaborators:	Asociacion Doctor Peset Para el Estudio de la Hematología Cephalon Pivotal S.L.
Information provided by:	Asociacion Doctor Peset Para el Estudio de la Hematología
ClinicalTrials.gov Identifier:	NCT00849355

Purpose

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

Condition	Intervention	Phase
No Hodgkin B Lymphoma	Drug: RCOMP-14 + rituximab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Prednisone Vincristine Myocet Rituximab Vincristine sulfate

U.S. FDA Resources

Further study details as provided by Asociacion Doctor Peset Para el Estudio de la Hematología:

Primary Outcome Measures:

Evaluate treatment efficacy by measuring response to treatment [ Time Frame: at the end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

evaluate cardiotoxicity and tolerability [ Time Frame: At the end of study ] [ Designated as safety issue: Yes ]
Evaluate progression free survival [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
Evaluate event free survival [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
Evaluate tumor free survival [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
Evaluate overall survival [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
Evaluate response duration [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
treatment adherence [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
time to progression [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
dose intensity and relative dose intensity [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	August 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
unique: Experimental 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.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849355

Contacts

Contact: Secundino Ferrer	+34961622536	ferrer_sec@gva.es
Contact: Felix Carbonell	+34961972000	carbonell_fel@gav.es

Locations

Spain
Hospital general universitario de Valencia	Active, not recruiting
Valencia, Spain, 46014
Hospital Universitario Dr. Peset	Active, not recruiting
Valencia, Spain, 46017
Hospital Universitario Puerta de Hierro	Active, not recruiting
Madrid, Spain, 28220
Hospital de Castellon	Active, not recruiting
Castellon, Spain, 12004
H. Arnau de Vilanova	Active, not recruiting
Valencia, Spain, 46015
Hospital de Getafe	Recruiting
Madrid, Spain
Contact: Jose García +34916839360 garciavela.joseantonio@gmail.com
Hospital Santa Mª del Rosell	Not yet recruiting
Murcia, Spain, 30203
Contact: Antonio Martinez +34968504800 amartifran@ono.com
Hospital son Llatzer	Active, not recruiting
Mallorca, Spain, 07198
hospital del Mar	Active, not recruiting
Barcelona, Spain, 08003
Hospital Severo Ochoa	Not yet recruiting
Madrid, Spain, 28211
Contact: Pedro Sanchez +34914818000 psanchez.hsvo@salud.madrid.org
Hospital Morales Messeguer	Not yet recruiting
Murcia, Spain, 30008
Contact: Jose Sanchez +34606388315 josej.sanchezz3@carm.es
Hospital Vall D'Hebrón	Active, not recruiting
Barcelona, Spain, 08035

Sponsors and Collaborators

Asociacion Doctor Peset Para el Estudio de la Hematología

Cephalon

Pivotal S.L.

More Information

No publications provided

Responsible Party:	Asociacion Doctor Peset Para el Estudio de la Hematología ( Secundino Ferrer )
Study ID Numbers:	ADOPEH-LINFMYO-2007
Study First Received:	February 20, 2009
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00849355 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Immunoproliferative Disorders
Immunologic Factors
Antineoplastic Agents, Hormonal
Rituximab
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Vincristine

Antimitotic Agents
Glucocorticoids
Hormones
Doxorubicin
Lymphatic Diseases
Tubulin Modulators
Antirheumatic Agents
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Lymphoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Therapeutic Uses
Lymphoma
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases

Antineoplastic Agents, Hormonal
Rituximab
Mitosis Modulators
Vincristine
Antimitotic Agents
Glucocorticoids
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Antirheumatic Agents
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 30, 2009