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Status:

COMPLETED

Rituximab and Combination Chemotherapy in Treating Older Patients With Previously Untreated B-Cell Lymphoma

Lead Sponsor:

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

Conditions:

Lymphoma

Eligibility:

All Genders

61-80 years

Phase:

PHASE2

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 * Determine a pharmacokinetic profile for pharmacokinetics-based or rituximab within a CHOP-14 regimen comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, and pr...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histological diagnosis of aggressive B-cell lymphoma
  • Previously untreated disease
  • Stage I-IV disease
  • CD20-positive disease
  • Any International Prognostic Index (IPI) score
  • No secondary lymphoma after prior chemotherapy or radiotherapy
  • No primary CNS lymphoma
  • No primary gastrointestinal (MALT) lymphoma
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • AST and ALT ≤ 3 times normal unless related to lymphoma
  • Bilirubin ≤ 2 mg/dL unless related to lymphoma
  • Creatinine ≤ 2 times normal unless related to lymphoma
  • Fertile patients must use effective contraception
  • No known allergic reactions against foreign proteins
  • No active infections requiring systemically administered antibiotics or antiviral medications
  • No noncompensated heart failure
  • No dilatative cardiomyopathy
  • No coronary heart disease with ST-segment depression in ECG
  • No myocardial infarction during the past 6 months
  • No chronic lung disease with hypoxemia
  • No severe noncompensated hypertension
  • No severe noncompensated diabetes mellitus
  • No clinical signs of cerebral dysfunction
  • No severe psychiatric disease
  • No known HIV infection
  • No active chronic hepatitis B or C infection
  • No other concurrent diseases that exclude the administration of therapy as outlined by the study protocol
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • More than 12 weeks since prior clinical trial participation
  • No prior participation in this study
  • No prior therapy, including murine antibody, for this cancer
  • No prior organ transplantation
  • No concurrent response-adapted radiotherapy ("iceberg radiotherapy")
  • No other concurrent anticancer chemotherapy or other study medication

Exclusion

    Key Trial Info

    Start Date :

    February 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2015

    Estimated Enrollment :

    586 Patients enrolled

    Trial Details

    Trial ID

    NCT00290667

    Start Date

    February 1 2004

    End Date

    November 1 2015

    Last Update

    May 18 2021

    Active Locations (338)

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

    Page 1 of 85 (338 locations)

    1

    University Hospital Brno

    Brno, Czechia, CZ-662 63

    2

    Charles University Hospital

    Prague, Czechia, CZ-150 06

    3

    Hopital Debrousse

    Lyon, France, 69322

    4

    Haematologisch Onkologische Praxis

    Aachen, Germany, 52070