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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Prof. Dr. Norbert Schmitz, German High-Grade Non-Hodgkin's Lymphoma Study Group
ClinicalTrials.gov Identifier:
NCT00129090
First received: August 10, 2005
Last updated: September 8, 2015
Last verified: September 2015

August 10, 2005
September 8, 2015
March 2003
October 2014   (final data collection date for primary outcome measure)
time to treatment failure [ Time Frame: 3 years after study inclusion ] [ Designated as safety issue: No ]
At 3 year follow up rate of treatments and time to treatment failure will be determined
time to treatment failure
Complete list of historical versions of study NCT00129090 on ClinicalTrials.gov Archive Site
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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
According to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better time to treatment failure (TTTF)

This study was primarily designed to compare aggressive conventional chemotherapy with a repetitive high-dose (HD) therapy program using identical, effective drugs at highest possible dose and dose intensity with/without addition of rituximab (initially 4 treatment arms). In 2004 the first amendment had to be added in order to close two treatment arms without rituximab due to recent data revealing a significant advantage for rituximab-treated patients with CD20+lymphoma.

A planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was raised from 6 to 12 administrations as recent publications gave hint for advantage. The last amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation problems.

As the high-dose arm was closed only CD20+ B-lymphoma were included past amendment 2.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma (NHL)
Drug: R-CHOEP 14 with 12x Rituximab
after amendment 3 patients receive 4x 375mg/m2 in cycle 1 (day 0,1,4,8), 2x 375/m2 in cycle 2 (day1,8) and 1x 375mg/m2 cycle 3-8 (day 1 of each cycle)
Other Name: 12 x Rituximab with 8 cycles of standard CHOEP-14
Experimental: R-CHOEP14 with 12x Rituximab
8 cycles of standard CHOP with etoposide in 14-day intervals. Patients with CD20+ lymphoma receive 12 doses of Rituximab (day 0,1,4,8 of cycle 1, day 1 and 8 of cycle 2, day1 of cycle 3-8 )
Intervention: Drug: R-CHOEP 14 with 12x 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
October 2017
October 2014   (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: Eastern Cooperative Oncology Group (ECOG) 0-3
  • Patient's written informed consent
  • Aggressive non-Hodgkin's lymphoma with CD20+ histology

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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00129090
DSHNHL 2002-1
Yes
Not Provided
Not Provided
Prof. Dr. Norbert Schmitz, German High-Grade Non-Hodgkin's Lymphoma Study Group
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
September 2015

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