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

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: No Hodgkin B Lymphoma
• Intervention / Treatment: Drug: RCOMP-14 + rituximab

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Secundino Ferrer; Phone Number: +34961622536; Email: ferrer_sec@gva.es
• Study Contact Backup: Name: Felix Carbonell; Phone Number: +34961972000; Email: carbonell_fel@gav.es

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
    • Not yet recruiting
    • Hospital Severo Ochoa
    • Contact: Pedro Sanchez; Phone Number: +34914818000; Email: psanchez.hsvo@salud.madrid.org
  • Madrid, Spain, 28220
    • Active, not recruiting
    • Hospital Universitario Puerta de Hierro
  • Madrid, Spain
    • Recruiting
    • Hospital de Getafe
    • Contact: Jose García; Phone Number: +34916839360; Email: garciavela.joseantonio@gmail.com
  • Mallorca, Spain, 07198
    • Active, not recruiting
    • Hospital Son Llatzer
  • Murcia, Spain, 30008
    • Not yet recruiting
    • Hospital Morales Messeguer
    • Contact: Jose Sanchez; Phone Number: +34606388315; Email: josej.sanchezz3@carm.es
  • Murcia, Spain, 30203
    • Not yet recruiting
    • Hospital Santa Mª del Rosell
    • Contact: Antonio Martinez; Phone Number: +34968504800; Email: amartifran@ono.com
  • 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

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

How is the study designed?

Design Details

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

Number of Arms

1

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	at the end of study

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Evaluate response duration	At the end of study
treatment adherence	At the end of study
time to progression	At the end of the study
dose intensity and relative dose intensity	At the end of the study

Collaborators and Investigators

• Sponsor: Asociacion Doctor Peset Para el Estudio de la Hematología
• Collaborators: Cephalon; Pivotal S.L.

Study record dates

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: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: ADOPEH-LINFMYO-2007