Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by German High-Grade Non-Hodgkin's Lymphoma Study Group.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
German High-Grade Non-Hodgkin's Lymphoma Study Group
ClinicalTrials.gov Identifier:
NCT00129090
First received: August 10, 2005
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

Comparison of aggressive conventional therapy with repetitive high-dose therapy plus rituximab. Hypothesis: better overall survival and/or progression-free survival in HDT+R.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: CHOEP + Rituximab
Drug: Mega-CHOEP + Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study to Compare Conventional Chemotherapy (CHOEP-14) + Rituximab vs High-Dose Chemotherapy Followed by Autologous Stem Cell Transplantation (Mega-CHOEP-21) + Rituximab in Younger Patients With Aggressive NHL

Resource links provided by NLM:


Further study details as provided by German High-Grade Non-Hodgkin's Lymphoma Study Group:

Primary Outcome Measures:
  • time to treatment failure

Estimated Enrollment: 396
Study Start Date: March 2003
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1B
8 x CHOEP-14 + 6 x R
Drug: CHOEP + Rituximab
8 x CHOEP-14 + 6 x Rituximab
Experimental: 2B
4 x R-MegaCHOEP
Drug: Mega-CHOEP + Rituximab
4 x R-Mega-CHOEP

Detailed Description:

This study compares aggressive conventional therapy (8 courses of rituximab plus CHOEP given every 2 weeks) with repetitive high-dose therapy (Mega-CHOEP) supplemented with rituximab. The study question is whether overall survival or progression-free survival is better with high-dose therapy than with conventional treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-60 years of age
  • Risk group International Prognostic Index (IPI) 2 and 3 (age adjusted)
  • Performance status: ECOG 0-3
  • Patient's written informed consent
  • Aggressive non-Hodgkin's lymphoma

Exclusion Criteria:

  • Already initiated lymphoma therapy
  • Serious accompanying disorder or impaired organ function
  • Bone marrow involvement > 25%
  • Known hypersensibility to the medications to be used
  • Known HIV-positivity
  • Active hepatitis infection
  • Suspicion that patient compliance will be poor
  • Simultaneous participation in other trials
  • Prior chemo- or radiotherapy for previous disorder
  • Other concomitant tumour disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129090

Contacts
Contact: Norbert Schmitz, Prof. +49 40 181885 ext 2005 norbert.schmitz@ak-stgeorg.lbk-hh.de

Locations
Germany
AK St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Norbert Schmitz, Prof.    +49 40 181885 ext 2005    norbert.schmitz@ak-stgeorg.lbk-hh.de   
Principal Investigator: Schmitz Norbert, Prof.         
Sponsors and Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Principal Investigator: Norbert Schmitz, Prof. German High-Grade Non-Hodgkin's Lymphoma Study Group
  More Information

No publications provided by German High-Grade Non-Hodgkin's Lymphoma Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deutsche Studiengruppe Hochmaligne Non-Hodgkin-Lymphome (DSHNHL)
ClinicalTrials.gov Identifier: NCT00129090     History of Changes
Other Study ID Numbers: DSHNHL 2002-1
Study First Received: August 10, 2005
Last Updated: May 5, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014