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.
Lead SponsorPolish Lymphoma Research Group
StatusCompleted No Results Posted
Indication/ConditionFollicular Lymphoma Lymphoplasmacytic Lymphoma Marginal Zone Lymphoma Small Lymphocytic Lymphoma
Intervention/Treatmentprednisone doxorubicin vincristine cyclophosphamide rituximab ...
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.
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
Prednisone 100 mg p.o. d. 1-5 q. 21 d.
Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
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