Trial | NCT00801281  Report issue

Title

First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    250
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.
Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy.
Study Started
Feb 28
2007
Primary Completion
Jun 25
2017
Study Completion
Jun 25
2017
Last Update
Jul 17
2017

Drug Rituximab

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

  • Other names: MabThera

Drug Cyclophosphamide

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

  • Other names: Endoxan, Cytoxan

Drug Doxorubicin

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

  • Other names: Adriamycin

Drug Vincristine

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

  • Other names: Oncovin

Drug Prednisone 1

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

  • Other names: Deltasone

Drug Prednisone 2

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

  • Other names: Deltasone

R-CVP Active Comparator

Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2

R-CHOP Experimental

Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1

Criteria 

Inclusion Criteria:

Histologically confirmed:
Follicular lymphoma grade 1, 2, 3a
Marginal zone lymphoma, including MALT type
Small lymphocytic lymphoma (BM inv. < 30%)
Lymphoplasmacytic lymphoma
Clinical stage II-IV (Ann Arbor). Stage I is allowed if bulky (Ø > 7 cm) or if radiotherapy is not appropriate in judgment of treating physician
Measurable lesion(s) in at least one site
Patients previously untreated
Patients presenting with symptoms requiring treatment:
Progressive disease
Symptoms related to tumor bulk
Cytopenias related to bone marrow and/or spleen involvement B symptoms
Age ≥ 18 years
Performance status </=2
Written informed consent

Exclusion Criteria:

Grade 3b FL
Transformed lymphoma
CNS involvement
Patient taking steroids for > 2 weeks during last 4 weeks at a dose equivalent to ≥ 20 mg prednisone
Other malignancy
Major surgery within 4 weeks
Hb < 8 g/dl, ANC < 1.5 x 109/L, Plt <100 109/L unless due to lymphoma
Impairment of renal function (creatinine > 1.5 x UNV) or liver function (total bilirubin 1.5 x UNV, SGOT > 2.5 x UNV not due to lymphoma
Known infection, with HBV, HCV (acute < 6 mos. or chronic hepatitis) or HIV
Serious underlying medical conditions
Life expectancy < 6 months
Known allergy to murine protein
No Results Posted