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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01009970

Enrollment

Registered

2009-11-09

Start date

2010-05-31

Completion date

2012-05-31

Last updated

2011-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

Diffuse Large B-Cell Lymphoma

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.

Interventions

DRUGRituximab

375 mg/m2 day 1

DRUGCyclophosphamide

750 mg/m2 day 2

DRUGVincristine

1,4 mg/m2 (max 2 mg) day 2

DRUGPrednisone

40 mg/m2 day 2-6

DRUGDoxorubicin

50 mg/m2 day 2

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Months to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Feasibility of R-COMP in cardiopathic patients	2 years

Secondary

Measure	Time frame
Response rates	1 year
Progression free survival	2 years
Overall Survival	3 years

Countries

Italy

Contacts

Primary ContactDaniela Denaro

ddenaro@ospedale.al.it0039-0131-206129

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026