Dose-Dense Therapy in Aggressive Lymphoma

August 15, 2007 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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

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.

Study Overview

Status

No longer available

Conditions

Lymphoma

Intervention / Treatment

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Fridrik MA, Hausmaninger H, Lang A, Drach J, Krieger O, Geissler D, Michlmayr G, Ulsperger E, Chott A, Oberaigner W, Greil R. Dose-dense therapy improves survival in aggressive non-Hodgkin's lymphoma. Ann Hematol. 2010 Mar;89(3):273-82. doi: 10.1007/s00277-009-0811-x. Epub 2009 Aug 20.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 15, 2007

First Submitted That Met QC Criteria

August 15, 2007

First Posted (Estimate)

August 17, 2007

Study Record Updates

Last Update Posted (Estimate)

August 17, 2007

Last Update Submitted That Met QC Criteria

August 15, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NHL-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.