Dose-Dense Therapy in Aggressive Lymphoma

Lymphoma Clinical Trial

Official title:

Phase 3 Study of Dose-Dense Therapy Versus CHOP in Aggressive Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00517894
• Other study ID #: NHL-5
• Status: No longer available
• Phase: N/A
• First received: August 15, 2007
• Last updated: August 15, 2007

Study information

• Verified date: August 2007
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Expanded Access

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Lymphoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie