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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

August 10, 2005
May 5, 2008
March 2003
August 2008   (final data collection date for primary outcome measure)
time to treatment failure
Same as current
Complete list of historical versions of study NCT00129090 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
  • Drug: CHOEP + Rituximab
    8 x CHOEP-14 + 6 x Rituximab
  • Drug: Mega-CHOEP + Rituximab
    4 x R-Mega-CHOEP
  • Active Comparator: 1B
    8 x CHOEP-14 + 6 x R
    Intervention: Drug: CHOEP + Rituximab
  • Experimental: 2B
    4 x R-MegaCHOEP
    Intervention: Drug: Mega-CHOEP + Rituximab
Schmitz N, Nickelsen M, Ziepert M, Haenel M, Borchmann P, Schmidt C, Viardot A, Bentz M, Peter N, Ehninger G, Doelken G, Ruebe C, Truemper L, Rosenwald A, Pfreundschuh M, Loeffler M, Glass B; German High-Grade Lymphoma Study Group (DSHNHL). Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma: an open-label, randomised, phase 3 trial (DSHNHL 2002-1). Lancet Oncol. 2012 Dec;13(12):1250-9. doi: 10.1016/S1470-2045(12)70481-3. Epub 2012 Nov 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
396
March 2011
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Norbert Schmitz, Prof. +49 40 181885 ext 2005 norbert.schmitz@ak-stgeorg.lbk-hh.de
Germany
 
NCT00129090
DSHNHL 2002-1
Not Provided
Deutsche Studiengruppe Hochmaligne Non-Hodgkin-Lymphome (DSHNHL)
German High-Grade Non-Hodgkin's Lymphoma Study Group
Deutsche Krebshilfe e.V., Bonn (Germany)
Principal Investigator: Norbert Schmitz, Prof. German High-Grade Non-Hodgkin's Lymphoma Study Group
German High-Grade Non-Hodgkin's Lymphoma Study Group
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP