Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diffuse Large B-Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

R-COMP

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

375 mg/m2 day 1

Cyclophosphamide

Intervention Type DRUG

750 mg/m2 day 2

Vincristine

Intervention Type DRUG

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

Prednisone

Intervention Type DRUG

40 mg/m2 day 2-6

Doxorubicin

Intervention Type DRUG

50 mg/m2 day 2

Interventions

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Rituximab

375 mg/m2 day 1

Intervention Type DRUG

Cyclophosphamide

750 mg/m2 day 2

Intervention Type DRUG

Vincristine

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

Intervention Type DRUG

Prednisone

40 mg/m2 day 2-6

Intervention Type DRUG

Doxorubicin

50 mg/m2 day 2

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michele Spina, MD

Role: STUDY_DIRECTOR

Centro di riferimento Oncologico di Aviano

Locations

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Ospedale SS Antonio Biagio e Cesare Arrigo

Alessandria, , Italy

Site Status RECRUITING