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

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

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

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

Intervention / Treatment
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* Drug: Rituximab
* Drug: Cyclophosphamide
* Drug: Doxorubicin
* Drug: Vincristine
* Drug: Prednisone 1
* Drug: Prednisone 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: R-CVP<br>Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2 | Drug: Rituximab<br>* Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.<br>* Other names: MabThera;Drug: Cyclophosphamide<br>* Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.<br>* Other names: Endoxan, Cytoxan;Drug: Vincristine<br>* Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.<br>* Other names: Oncovin;Drug: Prednisone 2<br>* Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.<br>* Other names: Deltasone;|
| Experimental: R-CHOP<br>Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1 | Drug: Rituximab<br>* Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.<br>* Other names: MabThera;Drug: Cyclophosphamide<br>* Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.<br>* Other names: Endoxan, Cytoxan;Drug: Doxorubicin<br>* Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.<br>* Other names: Adriamycin;Drug: Vincristine<br>* Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.<br>* Other names: Oncovin;Drug: Prednisone 1<br>* Prednisone 100 mg p.o. d. 1-5 q. 21 d.<br>* Other names: Deltasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival |  | +3 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | +2 yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Immunochemotherapy, Induction therapy, Maintenance therapy, Follicular lymphoma grade 1,2,3a, Marginal zone lymphoma, including MALT type, Small lymphocytic lymphoma (BM inv. <30%)