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Dose-Dense Therapy in Aggressive Lymphoma

Expanded access is no longer available for this treatment.

Sponsored by: Arbeitsgemeinschaft medikamentoese Tumortherapie
Information provided by: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT00517894
  Purpose

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 Intervention
Lymphoma
Drug: CEOP/IMVP-Dexa chemotherapy

MedlinePlus related topics:   Lymphoma   

ChemIDplus related topics:   Mesna    Ifosfamide    Etoposide    Filgrastim    Cyclophosphamide    Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus    Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Methotrexate    Prednisolone    6-Methylprednisolone    Depo-medrol    Medrol veriderm    Methylprednisolone    Methylprednisolone hemisuccinate    Methylprednisolone Sodium Succinate    Prednisolone acetate    Prednisolone sodium phosphate    Prednisolone Sodium Succinate    Vincristine sulfate    Vincristine    Etoposide phosphate    Epirubicin hydrochloride    Epirubicin    Calcium gluconate   

U.S. FDA Resources

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

Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

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
Detailed Description:

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

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both

Criteria

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
  Contacts and Locations

No Contacts or Locations Provided
  More Information


Study ID Numbers:   NHL-5
First Received:   August 15, 2007
Last Updated:   August 15, 2007
ClinicalTrials.gov Identifier:   NCT00517894
Health Authority:   Austria: Federal Ministry for Health and Women

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
lymphoma  
aggressive  
chemotherapy  
dose-dense  

Study placed in the following topic categories:
Dexamethasone
Immunoproliferative Disorders
Methylprednisolone
Lymphoma, small cleaved-cell, diffuse
Vincristine
Leucovorin
Methylprednisolone acetate
Prednisolone acetate
Cyclophosphamide
Epirubicin
Etoposide phosphate
Lymphatic Diseases
Ifosfamide
Prednisolone
Methotrexate
Lymphoma, Non-Hodgkin
Aggression
Lymphoproliferative Disorders
Mesna
Etoposide
Lymphoma
Dexamethasone acetate
Methylprednisolone Hemisuccinate
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on October 07, 2008




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