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
Recruitment status was Recruiting
Sponsor:
Asociacion Doctor Peset Para el Estudio de la Hematología
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
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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:
- 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 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 May 19, 2013