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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. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Asociacion Doctor Peset Para el Estudio de la Hematología.
Recruitment status was:  Recruiting
Pivotal S.L.
Information provided by:
Asociacion Doctor Peset Para el Estudio de la Hematología Identifier:
First received: February 20, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders 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
  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 identifier: NCT00849355

hospital del Mar
Barcelona, Spain, 08003
Hospital Vall D'Hebrón
Barcelona, Spain, 08035
Hospital de Castellon
Castellon, Spain, 12004
Hospital Severo Ochoa
Madrid, Spain, 28211
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28220
Hospital de Getafe
Madrid, Spain
Hospital son Llatzer
Mallorca, Spain, 07198
Hospital Morales Messeguer
Murcia, Spain, 30008
Hospital Santa Mª del Rosell
Murcia, Spain, 30203
Hospital general universitario de Valencia
Valencia, Spain, 46014
H. Arnau de Vilanova
Valencia, Spain, 46015
Hospital Universitario Dr. Peset
Valencia, Spain, 46017
Sponsors and Collaborators
Asociacion Doctor Peset Para el Estudio de la Hematología
Pivotal S.L.
  More Information

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 
Study First Received: February 20, 2009
Last Updated: February 20, 2009
Health Authority: Spain: Spanish Agency of Medicines

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 processed this record on January 17, 2017