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

Sponsor
German High-Grade Non-Hodgkin's Lymphoma Study Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT00129090
Collaborator
Deutsche Krebshilfe e.V., Bonn (Germany) (Other)
450
Enrollment
1
Location
1
Arm
175
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
Actual Enrollment :
450 participants
Allocation:
N/A
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 :
Mar 1, 2003
Actual Primary Completion Date :
Oct 1, 2014
Anticipated Study Completion Date :
Oct 1, 2017

Arms and Interventions

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 Names:
  • 12 x Rituximab with 8 cycles of standard CHOEP-14

    		•

    Outcome Measures

    Primary Outcome Measures

    1. time to treatment failure [3 years after study inclusion]

      At 3 year follow up rate of treatments and time to treatment failure will be determined

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Norbert Schmitz, director of study, German High-Grade Non-Hodgkin's Lymphoma Study Group
    ClinicalTrials.gov Identifier:
    NCT00129090
    Other Study ID Numbers:
    • DSHNHL 2002-1
    First Posted:
    Aug 11, 2005
    Last Update Posted:
    Sep 9, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Rituximab

    Study Results

    No Results Posted as of Sep 9, 2015