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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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
No Hodgkin B Lymphoma

Thank you

Trial Information

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


Phase II, multicenter, open , 1-arm study.


Inclusion Criteria:



1. Patients with histological diagnosis of Lymphoma no Hodgkin B CD20+ high degree of
mailgnancy

2. Patients no previously treated

3. stage III o IV

4. Informed consent

5. At least one measurable injury

6. Age >18

7. ECOG 0-2

8. Life expectancy >6 months

9. Cardiovascular risk defined as:Mild-moderate systolic dysfunction,isquemic
cardiopathy, diabetes mellitus, hypertension,left ventricular hypertrophy, cardiac
arrhythmia, moderate pulmonar hypertension

10. 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)

11. Use of a contraceptive method during study + 3 months -

Exclusion Criteria:

1. stage I or II with IPI=0

2. Symptomatic tumoral affection of Nervous central system

3. Lymphoma no hodgkin B indolent

4. Lymphoma no hodgkin B mantle-cell

5. Lymphoma no hodgkin T

6. lymphoprolifertaive syndrome post-transplantation or immunosuppression associated

7. cardiovacualr disease symptomatic

8. Cronic infection or acute serious

9. history of neoplasia in past 5 years

10. not able to understand the study or poor protocol adherence

11. Known Hypersensivity to any atudy drug

12. pregnant/lactant women

13. Previous participation in clinicla study in past 30 days

14. Previous treatment with antraciclines or any drug used in this study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate treatment efficacy by measuring response to treatment

Outcome Time Frame:

at the end of study

Safety Issue:

No

Authority:

Spain: Spanish Agency of Medicines

Study ID:

ADOPEH-LINFMYO-2007

NCT ID:

NCT00849355

Start Date:

August 2008

Completion Date:

November 2010

Related Keywords:

  • No Hodgkin B Lymphoma
  • Lymphoma

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