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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
Sponsor:
Information provided by (Responsible Party):
Polish Lymphoma Research Group

Study Description
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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.

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

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: R-CVP
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
 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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Event Free Survival [ Time Frame: +3 yrs ]

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: +2 yrs ]

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

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
Contacts and Locations
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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


Locations
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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
Sponsors and Collaborators
Polish Lymphoma Research Group
Investigators
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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
More Information
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Additional Information:

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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
Keywords provided by Polish Lymphoma Research Group:
Lymphoma
Immunochemotherapy
Induction therapy
Maintenance therapy
 Follicular lymphoma grade 1,2,3a
Marginal zone lymphoma, including MALT type
Small lymphocytic lymphoma (BM inv. <30%)
Additional relevant MeSH terms:
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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