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

Phase 3

Completed

• Conditions: Follicular Lymphoma; Lymphoplasmacytic Lymphoma; Marginal Zone Lymphoma; Small Lymphocytic Lymphoma
• Interventions: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin; Drug: Prednisone 2; Drug: Prednisone 1

• Registration Number: NCT00801281
• Lead Sponsor: Polish Lymphoma Research Group

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Primary Completion: 2017-06-25
• Study Completion: 2017-06-25
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R-CVP	Prednisone 2	Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
R-CVP	Vincristine	Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
R-CVP	Cyclophosphamide	Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
R-CHOP	Prednisone 1	Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
R-CHOP	Cyclophosphamide	Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
R-CVP	Rituximab	Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
R-CHOP	Rituximab	Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
R-CHOP	Doxorubicin	Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
R-CHOP	Vincristine	Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1

Primary Outcome Measures

Name	Time	Method
Event Free Survival	+3 yrs

Secondary Outcome Measures

Name	Time	Method
Response Rate	+2 yrs

Trial Locations

Locations (12)

Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation; 🇵🇱 Katowice, Poland

Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases; 🇵🇱 Warszawa, Poland

Oncology Centre of Lublin Region; 🇵🇱 Lublin, Poland

M.Sklodowska-Curie Institute - Oncology Centre; 🇵🇱 Warszawa, Poland

Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation; 🇵🇱 Wrocław, Poland

Podkarpacki Oncology Centre; 🇵🇱 Brzozów, Poland

Voivodeship Hospital, Oncology Ward; 🇵🇱 Elbląg, Poland

Institute of Haematology and Transfusiology; 🇵🇱 Warszawa, Poland

Regional Oncology Centre, Ward of Proliferative Diseases; 🇵🇱 Łódź, Poland

Collegium Medicum Jagiellonian University, Clinic of Haematology; 🇵🇱 Kraków, Poland

Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology; 🇵🇱 Gdańsk, Poland

SP ZOZ Silesian Centre of Cellular Transplantation; 🇵🇱 Wrocław, Poland