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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00801281

Acronym

PLRG4

Enrollment

250

Registered

2008-12-03

Start date

2007-02-28

Completion date

2017-06-25

Last updated

2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma

Keywords

Lymphoma, Immunochemotherapy, Induction therapy, Maintenance therapy, Follicular lymphoma grade 1,2,3a, Marginal zone lymphoma, including MALT type, Small lymphocytic lymphoma (BM inv. <30%)

Brief 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.

Detailed description

Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy.

Interventions

DRUGRituximab

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

DRUGCyclophosphamide

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

DRUGDoxorubicin

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

DRUGVincristine

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

DRUGPrednisone 1

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

DRUGPrednisone 2

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Event Free Survival	+3 yrs

Secondary

Measure	Time frame
Response Rate	+2 yrs

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026