Ciclophosphamide, Vincristine, Myocet and Prednisone, With Rituximab in 1st-Line Treatment for Patients With No-Hodgkin B Lymphoma and Cardiovascular (CV) Risk

Sponsor
Asociacion Doctor Peset Para el Estudio de la Hematología
Study ID
NCT00849355
Phase
PHASE2
Status
Unknown

Conditions

  • No Hodgkin B Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • RCOMP-14 + rituximab — DRUG
    Pretreatment: vincristine 1mg at day -6 and Methylprednisolone 100 mg from -6 to day 0. Treatment: rituximab 375m/m2 + ciclophosphamide 750 mg/m2 + Vincristine 1.4 mg/m2 + Doxorrubicine 50 mg/m2 at day 1 and every 14d. Prednisone 100 mg/d from day 1 to 5 and every 14 d.

Study Details

The purpose of this study is 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

Key Dates

Start date
Aug 31, 2008
Status verified
Feb 2009
Primary completion
Nov 30, 2009
Completion
Nov 30, 2010

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: unique
    RCOMP-14 with Rituximab

Primary Outcome Measure

Evaluate treatment efficacy by measuring response to treatment [ Time Frame: at the end of study ]

Central Contacts