First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
NCT ID: NCT00801281
Last Updated: 2017-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2007-02-28
2017-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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R-CVP
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
Rituximab
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
Cyclophosphamide
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
Vincristine
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
Prednisone 2
Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.
R-CHOP
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
Rituximab
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
Cyclophosphamide
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
Doxorubicin
Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
Vincristine
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
Prednisone 1
Prednisone 100 mg p.o. d. 1-5 q. 21 d.
Interventions
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Rituximab
Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
Cyclophosphamide
Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
Doxorubicin
Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
Vincristine
Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
Prednisone 1
Prednisone 100 mg p.o. d. 1-5 q. 21 d.
Prednisone 2
Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Polish Lymphoma Research Group
NETWORK
Responsible Party
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Principal Investigators
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Jan A Walewski, Prof.
Role: PRINCIPAL_INVESTIGATOR
Vice-president of PLRG
Maria Podolak-Dawidziak, Prof.
Role: STUDY_CHAIR
PLRG Board Member
Beata Stella-Hołowiecka, Assoc. Prof.
Role: STUDY_CHAIR
PLRG Member
Locations
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Podkarpacki Oncology Centre
Brzozów, , Poland
Voivodeship Hospital, Oncology Ward
Elblag, , Poland
Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology
Gdansk, , Poland
Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation
Katowice, , Poland
Collegium Medicum Jagiellonian University, Clinic of Haematology
Krakow, , Poland
Regional Oncology Centre, Ward of Proliferative Diseases
Lodz, , Poland
Oncology Centre of Lublin Region
Lublin, , Poland
Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases
Warsaw, , Poland
Institute of Haematology and Transfusiology
Warsaw, , Poland
M.Sklodowska-Curie Institute - Oncology Centre
Warsaw, , Poland
Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation
Wroclaw, , Poland
SP ZOZ Silesian Centre of Cellular Transplantation
Wroclaw, , Poland
Countries
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Related Links
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Click here to provide more information about this study: PLRG4
Other Identifiers
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R-CVP/CHOP
Identifier Type: -
Identifier Source: org_study_id
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