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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849355
Recruitment Status : Unknown
Verified February 2009 by Asociacion Doctor Peset Para el Estudio de la Hematología.
Recruitment status was:  Recruiting
First Posted : February 23, 2009
Last Update Posted : February 23, 2009
Pivotal S.L.
Information provided by:
Asociacion Doctor Peset Para el Estudio de la Hematología

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

Condition or disease Intervention/treatment Phase
No Hodgkin B Lymphoma Drug: RCOMP-14 + rituximab Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Steroids
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Evaluate treatment efficacy by measuring response to treatment [ Time Frame: at the end of study ]

Secondary Outcome Measures :
  1. evaluate cardiotoxicity and tolerability [ Time Frame: At the end of study ]
  2. Evaluate progression free survival [ Time Frame: At the end of study ]
  3. Evaluate event free survival [ Time Frame: At the end of study ]
  4. Evaluate tumor free survival [ Time Frame: At the end of study ]
  5. Evaluate overall survival [ Time Frame: At the end of study ]
  6. Evaluate response duration [ Time Frame: At the end of study ]
  7. treatment adherence [ Time Frame: At the end of study ]
  8. time to progression [ Time Frame: At the end of the study ]
  9. dose intensity and relative dose intensity [ Time Frame: At the end of the study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00849355

Contact: Secundino Ferrer +34961622536
Contact: Felix Carbonell +34961972000

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 Severo Ochoa Not yet recruiting
Madrid, Spain, 28211
Contact: Pedro Sanchez    +34914818000   
Hospital Universitario Puerta de Hierro Active, not recruiting
Madrid, Spain, 28220
Hospital de Getafe Recruiting
Madrid, Spain
Contact: Jose García    +34916839360   
Hospital son Llatzer Active, not recruiting
Mallorca, Spain, 07198
Hospital Morales Messeguer Not yet recruiting
Murcia, Spain, 30008
Contact: Jose Sanchez    +34606388315   
Hospital Santa Mª del Rosell Not yet recruiting
Murcia, Spain, 30203
Contact: Antonio Martinez    +34968504800   
Hospital general universitario de Valencia Active, not recruiting
Valencia, Spain, 46014
H. Arnau de Vilanova Active, not recruiting
Valencia, Spain, 46015
Hospital Universitario Dr. Peset Active, not recruiting
Valencia, Spain, 46017
Sponsors and Collaborators
Asociacion Doctor Peset Para el Estudio de la Hematología
Pivotal S.L.

Responsible Party: Secundino Ferrer, Asociacion Doctor Peset Para el Estudio de la Hematología Identifier: NCT00849355     History of Changes
Other Study ID Numbers: ADOPEH-LINFMYO-2007
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: February 23, 2009
Last Verified: February 2009

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