Overview

This trial is active, not recruiting.

Conditions follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma
Treatments rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone 1, prednisone 2
Phase phase 3
Target CD20
Sponsor Polish Lymphoma Research Group
Start date February 2007
End date June 2017
Trial size 250 participants
Trial identifier NCT00801281, R-CVP/CHOP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
rituximab MabThera
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
cyclophosphamide Endoxan, Cytoxan
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
vincristine Oncovin
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
prednisone 2 Deltasone
Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.
(Experimental)
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
rituximab MabThera
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
cyclophosphamide Endoxan, Cytoxan
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
doxorubicin Adriamycin
Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
vincristine Oncovin
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
prednisone 1 Deltasone
Prednisone 100 mg p.o. d. 1-5 q. 21 d.

Primary Outcomes

Measure
Event Free Survival
time frame: +3 yrs

Secondary Outcomes

Measure
Response Rate
time frame: +2 yrs

Eligibility Criteria

Male or female participants at least 18 years old.

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 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

Additional Information

Official title First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG.
Principal investigator Jan A Walewski, Prof.
Description Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Polish Lymphoma Research Group.