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

Last updated: July 12, 2017
Sponsor: Polish Lymphoma Research Group
Overall Status: Completed

Phase

3

Condition

Lymphoproliferative Disorders

Chronic Lymphocytic Leukemia

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

NCT00801281
R-CVP/CHOP
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ifradiotherapy 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

Exclusion Criteria:

  • Grade 3b FL

  • Transformed lymphoma

  • CNS involvement

  • Patient taking steroids for > 2 weeks during last 4 weeks at a dose equivalent to ≥ 20mg 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 (totalbilirubin 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

Total Participants: 250
Study Start date:
February 01, 2007
Estimated Completion Date:
June 25, 2017

Study Description

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

Connect with a study center

  • Podkarpacki Oncology Centre

    Brzozów, 36-200
    Poland

    Site Not Available

  • Podkarpacki Oncology Centre

    Brzozów, 36-200
    Poland

    Site Not Available

  • Voivodeship Hospital, Oncology Ward

    ElblÄ…g, 82-300
    Poland

    Site Not Available

  • Voivodeship Hospital, Oncology Ward

    Elbląg, 82-300
    Poland

    Site Not Available

  • Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology

    Gdańsk, 80-211
    Poland

    Site Not Available

  • Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology

    Gdańsk, 80-211
    Poland

    Site Not Available

  • Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation

    Katowice, 40-029
    Poland

    Site Not Available

  • Collegium Medicum Jagiellonian University, Clinic of Haematology

    Kraków, 31-501
    Poland

    Site Not Available

  • Collegium Medicum Jagiellonian University, Clinic of Haematology

    Kraków, 31-501
    Poland

    Site Not Available

  • Voivodeship Podkarpacki Hospital

    Krosno, 38-400
    Poland

    Site Not Available

  • Oncology Centre of Lublin Region

    Lublin, 20-090
    Poland

    Site Not Available

  • Health Care Centre Mrukmed Sp. p.

    Rzeszów, 35-242
    Poland

    Site Not Available

  • Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases

    Warszawa, 02-507
    Poland

    Site Not Available

  • Institute of Haematology and Transfusiology

    Warszawa, 02-776
    Poland

    Site Not Available

  • M.Sklodowska-Curie Institute - Oncology Centre

    Warszawa, 02-782
    Poland

    Site Not Available

  • Medical Academy in WrocÅ‚aw; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation

    Wrocław, 50-367
    Poland

    Site Not Available

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

    Wrocław, 50-367
    Poland

    Site Not Available

  • SP ZOZ Silesian Centre of Cellular Transplantation

    Wrocław, 53-439
    Poland

    Site Not Available

  • Regional Oncology Centre, Ward of Proliferative Diseases

    Łódź, 93-509
    Poland

    Site Not Available

  • Regional Oncology Centre, Ward of Proliferative Diseases

    Łódź, 93-509
    Poland

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.