First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance. (PLRG4)

Polish Lymphoma Research Group

Status and phase: Completed; Phase 3

Conditions: Marginal Zone Lymphoma; Small Lymphocytic Lymphoma; Follicular Lymphoma; Lymphoplasmacytic Lymphoma

Treatments: Drug: Prednisone 1; Drug: Prednisone 2; Drug: Doxorubicin; Drug: Vincristine; Drug: Cyclophosphamide; Drug: Rituximab

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00801281

R-CVP/CHOP

Details and patient eligibility

About

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.

Full description

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

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

R-CVP

Active Comparator group

Description:

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

Treatment:

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Vincristine

Drug: Prednisone 2

R-CHOP

Experimental group

Description:

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

Treatment:

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Vincristine

Drug: Doxorubicin

Drug: Prednisone 1