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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Asociacion Doctor Peset Para el Estudio de la Hematología.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Cephalon
Pivotal S.L.
Information provided by:
Asociacion Doctor Peset Para el Estudio de la Hematología
ClinicalTrials.gov Identifier:
NCT00849355
First received: February 20, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
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.


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Rituximab
Vincristine
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014