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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


Phase 2
18 Months
N/A
Open (Enrolling)
Both
Diffuse Large B-Cell Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of R-COMP in cardiopathic patients

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Michele Spina, MD

Investigator Role:

Study Director

Investigator Affiliation:

Centro di riferimento Oncologico di Aviano

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

IIL-HEART01

NCT ID:

NCT01009970

Start Date:

May 2010

Completion Date:

May 2012

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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