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

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ClinicalTrials.gov Identifier: NCT00129090
Recruitment Status : Unknown
Verified September 2015 by Prof. Dr. Norbert Schmitz, German High-Grade Non-Hodgkin's Lymphoma Study Group.
Recruitment status was:  Active, not recruiting
First Posted : August 11, 2005
Last Update Posted : September 9, 2015
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

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma (NHL) Drug: R-CHOEP 14 with 12x Rituximab Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2003
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. time to treatment failure [ Time Frame: 3 years after study inclusion ]
    At 3 year follow up rate of treatments and time to treatment failure will be determined



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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: 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129090


Locations
Germany
AK St. Georg
Hamburg, Germany, 20099
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Norbert Schmitz, director of study, German High-Grade Non-Hodgkin's Lymphoma Study Group
ClinicalTrials.gov Identifier: NCT00129090     History of Changes
Other Study ID Numbers: DSHNHL 2002-1
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

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