Text Size

Dose-Dense Therapy in Aggressive Lymphoma

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00517894
First received: August 15, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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

No publications provided by Arbeitsgemeinschaft medikamentoese Tumortherapie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

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

Additional relevant MeSH terms:
Aggression
Lymphoma
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013