Dose-Dense Therapy in Aggressive Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517894
Recruitment Status : No longer available
First Posted : August 17, 2007
Last Update Posted : August 17, 2007
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie

Brief Summary:
To investigate if a dose-dense chemotherapy with weekly chemotherapy compared to standard treatment every 3 weeks results in better survival in aggressive non-Hodgkin's lymphoma.

Condition or disease Intervention/treatment
Lymphoma Drug: CEOP/IMVP-Dexa chemotherapy

Detailed Description:
Patients are randomized to receive dose-dense CEOP/IMVP-Dexa chemotherapy or standard 3-weekly CHOP.

Study Type : Expanded Access
Official Title: Phase 3 Study of Dose-Dense Therapy Versus CHOP in Aggressive Non-Hodgkin's Lymphoma

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Intervention Details:
    Drug: CEOP/IMVP-Dexa chemotherapy
    Cyclophosphamide 750 mg/m2 i.v. d 1, epirubicin 70 mg/m2 i.v d 1, vincristine 1.4 mg/m2 i.v. d 1+8, prednisolone 100 mg p.o. d 1-5, ifosfamide 2000 mg/m2 i.v. d 15-17, etoposide 100 mg/m2 i.v. d 15-17, dexamethasone 40 mg p.o. or i.v. d 15-19, methotrexate 800 mg/m2 i.v. d 22. Mesna was given with ifosfamide, calcium-folinate rescue after methotrexate. Filgrastim was given on days 2-7, 9-12, 18-21, 23-28

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • 18 and 70 years of age
  • Centrally reviewed, histologically proven diffuse large B-cell, anaplastic large-cell, or peripheral T-cell unspecified
  • Measurable disease
  • All stages

Exclusion Criteria:

  • Lymphoblastic or Burkitt histology
  • CNS-disease
  • HIV-positive
  • pregnant or lactating women
  • Pretreatment
  • Other malignancy
  • Concomitant diseases that forbid chemotherapy

No Contacts or Locations Provided

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00517894     History of Changes
Other Study ID Numbers: NHL-5
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: August 17, 2007
Last Verified: August 2007

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms