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.
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Prof. Dr. Norbert Schmitz, German High-Grade Non-Hodgkin's Lymphoma Study Group Identifier:
First received: August 10, 2005
Last updated: September 8, 2015
Last verified: September 2015
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)

Condition Intervention Phase
Non-Hodgkin's Lymphoma (NHL)
Drug: R-CHOEP 14 with 12x Rituximab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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 [ 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

Enrollment: 450
Study Start Date: March 2003
Estimated Study Completion Date: October 2017
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 )
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

Detailed Description:

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.


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00129090

AK St. Georg
Hamburg, Germany, 20099
Sponsors and Collaborators
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
  More Information

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

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Dr. Norbert Schmitz, director of study, German High-Grade Non-Hodgkin's Lymphoma Study Group Identifier: NCT00129090     History of Changes
Other Study ID Numbers: DSHNHL 2002-1
Study First Received: August 10, 2005
Last Updated: September 8, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 30, 2015