First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.

Sponsor
Polish Lymphoma Research Group
Study ID
NCT00801281
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
  • Cyclophosphamide — DRUG
    Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
  • Doxorubicin — DRUG
    Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
  • Vincristine — DRUG
    Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
  • Prednisone 1 — DRUG
    Prednisone 100 mg p.o. d. 1-5 q. 21 d.
  • Prednisone 2 — DRUG
    Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.

Study Details

Evaluation of event free survival (EFS) of patients treated with the study chemotherapy induction program: R-CHOP compared to the standard R-CVP regimen and response rates, time to best response, PFS, OS, neutropenic fever rate, infection rate, change in Ig levels, change in lymphocyte subpopulations counts in previously untreated indolent lymphoma patients in need of systemic treatment.

Key Dates

First listed
Dec 3, 2008
Start date
Feb 28, 2007
Status verified
Jul 2017
Primary completion
Jun 25, 2017
Completion
Jun 25, 2017

Study Design

Enrollment
250 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: R-CVP
    Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
  • Experimental: R-CHOP
    Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1

Primary Outcome Measure

Event Free Survival [ Time Frame: +3 yrs ]

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