Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma
Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients
2 other identifiers
interventional
50
1 country
32
Brief Summary
This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2010
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
November 9, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedOctober 13, 2011
October 1, 2011
1 year
November 6, 2009
October 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of R-COMP in cardiopathic patients
2 years
Secondary Outcomes (3)
Response rates
1 year
Progression free survival
2 years
Overall Survival
3 years
Study Arms (1)
1
EXPERIMENTALR-COMP
Interventions
Eligibility Criteria
You may qualify if:
- NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL;
- Age \>= 18 years;
- Presence of at least 1 factor that defines the cardiopathy;
- Life expectancy \> 3 months;
- In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy;
- Written informed consent.
You may not qualify if:
- Histology different from NHL diffuse large cell CD20 + or follicular IIIb
- Age \< 18 years
- Inability to sign informed consent;
- HIV positivity;
- Patients HBsAg positive;
- AST/ALT \> 2 times the standard;
- Bilirubin \> 2 times the standard;
- Creatinine \> 2.5 mg / dl;
- Location of CNS disease;
- Pregnancy ongoing;
- Damage to that organ or medical problems that could interfere with the therapy;
- Current uncontrolled infection;
- Senile dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Ospedale SS Antonio Biagio e Cesare Arrigo
Alessandria, Italy
Università di Bari
Bari, Italy
Ospedale degli Infermi
Biella, Italy
Spedali Civili
Brescia, Italy
Ospedale Civitanova Marche
Civitanova Marche, Italy
AO Annunziata
Cosenza, Italy
Ospedale San Carlo
Cosenza, Italy
Ospedale Vito Fazzi
Lecce, Italy
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori (IRST)
Meldola (FC), Italy
A O Papardo
Messina, Italy
Ospedale Niguarda Cà Granda
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Centro oncologico modenese
Modena, Italy
AO Universitaria Paolo Giaccone
Palermo, Italy
Ospedale La Maddalena
Palermo, Italy
A O Universitaria di Parma
Parma, Italy
Ospedale Santa Maria della Misericordia
Perugia, Italy
Ausl Ravenna
Ravenna, Italy
Ospedale Bianchi Melacrino Morelli
Reggio Calabria, Italy
AO Santa Maria Nuova
Reggio Emilia, Italy
Ausl Rimini
Rimini, Italy
Istituto Regina Elena
Roma, Italy
Ospedale Sant'Eugenio
Roma, Italy
Università La Sapienza
Roma, Italy
Clinica Humanitas
Rozzano (MI), Italy
Casa sollievo della sofferenza
San Giovanni Rotondo, Italy
Università di Sassari
Sassari, Italy
Azienda Ospedaliera senese
Siena, Italy
Ospedale San Giovanni Battista Molinette
Torino, Italy
Ospedale Riuniti
Trieste, Italy
Santa Maria della Misericordia
Udine, Italy
Ospedale di circolo e Fondazione Macchi
Varese, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michele Spina, MD
Centro di riferimento Oncologico di Aviano
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2009
First Posted
November 9, 2009
Study Start
May 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2012
Last Updated
October 13, 2011
Record last verified: 2011-10