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

NCT00801281 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2017-07-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Rituximab

Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.

DRUG

Cyclophosphamide

Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.

DRUG

Doxorubicin

Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.

DRUG

Vincristine

Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.

DRUG

Prednisone 1

Prednisone 100 mg p.o. d. 1-5 q. 21 d.

DRUG

Prednisone 2

Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.

Sponsors & Collaborators

  • Polish Lymphoma Research Group

    lead NETWORK

Principal Investigators

  • Jan A Walewski, Prof. · Vice-president of PLRG

  • Maria Podolak-Dawidziak, Prof. · PLRG Board Member

  • Beata Stella-Hołowiecka, Assoc. Prof. · PLRG Member

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2017-06-25
Completion
2017-06-25

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00801281 on ClinicalTrials.gov