First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance. (PLRG4)
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ClinicalTrials.gov Identifier: NCT00801281 |
Recruitment Status :
Completed
First Posted : December 3, 2008
Last Update Posted : July 17, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Follicular Lymphoma Marginal Zone Lymphoma Small Lymphocytic Lymphoma Lymphoplasmacytic Lymphoma | Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone 1 Drug: Prednisone 2 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | June 25, 2017 |
Actual Study Completion Date : | June 25, 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: R-CVP
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
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Drug: Rituximab
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
Other Name: MabThera Drug: Cyclophosphamide Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
Other Name: Endoxan, Cytoxan Drug: Vincristine Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
Other Name: Oncovin Drug: Prednisone 2 Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.
Other Name: Deltasone |
Experimental: R-CHOP
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
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Drug: Rituximab
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
Other Name: MabThera Drug: Cyclophosphamide Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
Other Name: Endoxan, Cytoxan Drug: Doxorubicin Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
Other Name: Adriamycin Drug: Vincristine Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
Other Name: Oncovin Drug: Prednisone 1 Prednisone 100 mg p.o. d. 1-5 q. 21 d.
Other Name: Deltasone |
- Event Free Survival [ Time Frame: +3 yrs ]
- Response Rate [ Time Frame: +2 yrs ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801281
Poland | |
Podkarpacki Oncology Centre | |
Brzozów, Poland, 36-200 | |
Voivodeship Hospital, Oncology Ward | |
Elbląg, Poland, 82-300 | |
Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology | |
Gdańsk, Poland, 80-211 | |
Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation | |
Katowice, Poland, 40-029 | |
Collegium Medicum Jagiellonian University, Clinic of Haematology | |
Kraków, Poland, 31-501 | |
Oncology Centre of Lublin Region | |
Lublin, Poland, 20-090 | |
Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases | |
Warszawa, Poland, 02-507 | |
Institute of Haematology and Transfusiology | |
Warszawa, Poland, 02-776 | |
M.Sklodowska-Curie Institute - Oncology Centre | |
Warszawa, Poland, 02-782 | |
Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation | |
Wrocław, Poland, 50-367 | |
SP ZOZ Silesian Centre of Cellular Transplantation | |
Wrocław, Poland, 53-439 | |
Regional Oncology Centre, Ward of Proliferative Diseases | |
Łódź, Poland, 93-509 |
Principal Investigator: | Jan A Walewski, Prof. | Vice-president of PLRG | |
Study Chair: | Maria Podolak-Dawidziak, Prof. | PLRG Board Member | |
Study Chair: | Beata Stella-Hołowiecka, Assoc. Prof. | PLRG Member |
Responsible Party: | Polish Lymphoma Research Group |
ClinicalTrials.gov Identifier: | NCT00801281 |
Other Study ID Numbers: |
R-CVP/CHOP |
First Posted: | December 3, 2008 Key Record Dates |
Last Update Posted: | July 17, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Lymphoma Immunochemotherapy Induction therapy Maintenance therapy |
Follicular lymphoma grade 1,2,3a Marginal zone lymphoma, including MALT type Small lymphocytic lymphoma (BM inv. <30%) |
Lymphoma Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Lymphoma, B-Cell Leukemia, B-Cell Leukemia, Lymphoid |
Leukemia Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Prednisone Cyclophosphamide Rituximab Doxorubicin Vincristine Immunosuppressive Agents |