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Status:

COMPLETED

Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma

Lead Sponsor:

German High-Grade Non-Hodgkin's Lymphoma Study Group

Conditions:

Lymphoma

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with t...

Detailed Description

OBJECTIVES: Primary * Compare the efficacy of 2 different schedules of immunochemotherapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in patients w...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:
  • Grade 3 follicular lymphoma
  • Diffuse B-cell lymphoma, including diffuse large cell lymphoma with any of the following variants:
  • Centroblastic
  • Immunoblastic
  • Plasmablastic
  • Anaplastic large cell
  • T-cell-rich B-cell lymphoma
  • Primary effusion lymphoma
  • Intravascular B-cell lymphoma
  • Primary mediastinal B-cell lymphoma
  • Burkitt's or Burkitt-like lymphoma
  • Mantle cell lymphoma (blastoid)
  • Aggressive marginal zone lymphoma (monocytoid)
  • Previously untreated disease
  • CD20-positive disease
  • International Prognostic Index (IPI) score 0
  • No bulky disease
  • Largest single or conglomerate tumor \< 7.5 cm in diameter
  • No mucosa-associated lymphoid tissue (MALT) lymphoma
  • No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • Platelet count ≥ 100,000/mm\^3
  • WBC ≥ 2,500/mm\^3
  • Lactate dehydrogenase normal
  • Not pregnant or lactating
  • Fertile patients must use effective contraception during and for 1 year after study participation
  • Negative pregnancy test
  • No known hypersensitivity to the study medications
  • No known HIV-positivity
  • No active hepatitis infection
  • No impaired left ventricular function
  • No severe cardiac arrhythmias
  • No other impaired organ function
  • No other serious disorder
  • No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy or radiotherapy
  • No prior immunosuppressive treatment with cytostatics
  • No planned radiotherapy to extranodal involvement
  • No concurrent participation in other treatment studies

Exclusion

    Key Trial Info

    Start Date :

    November 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2018

    Estimated Enrollment :

    592 Patients enrolled

    Trial Details

    Trial ID

    NCT00278421

    Start Date

    November 1 2005

    End Date

    August 1 2018

    Last Update

    March 11 2021

    Active Locations (78)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 20 (78 locations)

    1

    Haematologisch Onkologische Praxis

    Aachen, Germany, 52070

    2

    Klinikum Augsburg

    Augsburg, Germany, DOH-86156

    3

    Klinikum Bayreuth

    Bayreuth, Germany, D-95445

    4

    Haematologisch-Onkologische Schwerpunktpraxis - Weilheim

    Berlin, Germany, 13357